A Phase 3 interventional study of HYQVIA and 0.25% albumin placebo solution with rHuPH20 in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by Baxalta now part of Shire. Completed at 83 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Baxalta now part of Shire (part of Takeda) · Phase 3, Interventional, and Treatment
The aim of this study is to learn more about the following treatment options in adults with CIDP:
The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C.
The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
This study's enrollment of 138 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →Baxalta now part of Shire is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
First submitted before Baxalta became part of Takeda.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
INCAT disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1 (whether from upper or lower extremities), or 2 (if at least 1 point is from an upper extremity) at screening and/or baseline will be required to have a history of significant disability as defined by an INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. Participants will be eligible if one of the below eligibility criteria are met:
Screening and Baseline INCAT disability score of between 3 and 7 inclusive.
Exclusion Criteria:
Any neuropathy of other causes, including:
Abnormal laboratory values at screening:
Participants with acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of develop thrombotic events. Examples include:
a. Hereditary Thrombophilias i. Factor V Leiden mutation. ii. Prothrombin 20210A mutation. iii. Protein C deficiency. iv. Protein S deficiency. v. Antithrombin deficiency. b. Acquired thrombophilias i. Antiphospholipid antibody syndrome. ii. Activated protein C Resistance acquired. iii. Homocystinemia.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, following by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.
Biological: HYQVIA
Participants received rHuPH20 80 U/I0 mL placebo solution, followed by SC placebo infusion at matching infusion volume as the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.
Biological: 0.25% albumin placebo solution with rHuPH20
Participants who were enrolled to receive placebo with rHuPH20 and achieved chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg bi-weekly (BW), followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.
Biological: IGIV GAMMAGARD LIQUID/KIOVIG
Participants who were enrolled to receive HYQVIA/HyQvia (rHuPH20) and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 28.67 weeks or until relapse.
Biological: IGIV GAMMAGARD LIQUID/KIOVIG
Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Biological: IGIV GAMUNEX®-C
Drug pages: Immunoglobulin G · Hyaluronoglucosaminidase
Participants will receive HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
Also known as: 10%) with recombinant human hyaluronidase (rHuPH20), Immune Globulin Infusion 10% (Human) (IGI, IGI, 10% with rHuPH20
Participants will receive placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20.
Drug page: Immunoglobulins
Participants will receive GAMMAGARD LIQUID/KIOVIG
Also known as: Immune Globulin Infusion (Human), Intravenous immunoglobulin G, 10% (GAMMAGARD LIQUID/KIOVIG), GAMMAGARD LIQUID
Participants will receive GAMUNEX®-C
Also known as: Immune Globulin Infusion (Human), Intravenous immunoglobulin G, Approved IGIV product for US sites
Epoch 1: Relapse Rate
Relapse rate is defined as the percentage of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of \>=1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
Time frame: Week 32 End of Epoch 1 Treatment (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET)
Epoch 2: Responder Rate
Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of \>=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period \[6 months\] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
Time frame: Up to 6 Months post-Epoch 1 (End of Epoch 2 Treatment [EOE2T])/Unscheduled visit assessment (UV)/Early Termination
Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability
Defined as one or more of the following: an increase of \>=1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience CIDP worsening (defined as a \>=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); \>=4 points decrease in raw Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period). Participants are rounded off to nearest single decimal point.
Time frame: Week 32 (EOET1)/UV/ET
Time to Relapse
Time to relapse is defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse. Participants who did not relapse were censored at their end of study.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS)
The Rasch-Built Overall Disability Scale (R-ODS) is a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participant with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (i.e, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion. The centile metric R-ODS score range is 0 to 100. Higher scores indicate better condition. The centile metric R-ODS score was used in the ANCOVA analysis. ANCOVA was used for the analysis.
Time frame: Pre-subcutaneous (SC) treatment baseline, end of Epoch 1 treatment (approximately 7.3 months)
Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality
An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Participants Experiencing Causally Related Serious and/or Non-Serious Adverse Events (SAEs and/or AEs)
AE=any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g.,abnormal laboratory finding), symptom (e.g.,rash, pain, discomfort, fever, dizziness, etc.), disease (e.g.,peritonitis,bacteremia,etc.), outcome of death temporally associated with use of IP,considered causally related to the IP. SAE=untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, thromboembolic events, hemolytic anemia. Non-SAE=AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality
AE: any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. SAE: an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. Participants can have more than one adverse event.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Adverse Events (AEs) Temporally Associated With Infusions
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one temporally associated with infusion adverse event.
Time frame: During an infusion or within 72 hours after completion of an infusion (up to Week 32)
Epoch 1: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions
AR plus suspected AR: any AE that meets any of the criteria: AE considered by either investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following end of IP infusion, or AE for which causality assessment is missing or indeterminate. SAE: untoward medical occurrence that at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. Nonserious AE is AE that does not meet the criteria. Infusion per event = number of events / total number of infusions administered (started) to participants in analysis set. Participants can have more than one AR/suspected AR associated with infusion.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one TEAE associated with infusion.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions
AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. Treatment-emergent adverse events (TEAEs) are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Infusions in Participants for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs)
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Participant
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-year
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Infusion
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Time frame: Week 32 (EOET1)/UV/ET
Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
Number of participants who developed binding and/or neutralizing antibodies to rHuPH20 in Epoch 1 were reported. High-binding antibodies is defined as number of participants who had at least one anti-rHuPH20 antibody titer ≥1:160 during treatment.
Time frame: Week 32 (EOET1)/UV/ET
Epoch 2: Number of Participants Experiencing Any Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality
Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events regardless of causality in Epoch 2 was reported.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Number of Participants Experiencing Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs)
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs
An adverse reaction/suspected adverse reaction is defined as an Adverse Event that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one adverse event.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Number of Adverse Events (AEs) Temporally Associated With Infusions
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one adverse event.
Time frame: During an infusion or within 72 hours after completion of an infusion (up to Week 32)
Epoch 2: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one AR/SAR.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one treatment-emergent systemic AEs.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions
AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. TEAEs are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-Year
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected Ars, Expressed as Number of Events Per Infusion
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Epoch 2: Percentage of Participants With Clinically Meaningful Improvement in Functional Ability
Defined as one or more of the following: a decrease of \>=1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience CIDP improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; \>=4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period \[6 months\] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
Time frame: Throughout Epoch 2, up to 6 months post-Epoch 1
Participants took part in the study at 54 investigative sites from December 15, 2015 to February 23, 2022. Participants with a diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) were enrolled in this study.
| Milestone | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|---|---|
| Started | 70 | 62 | 0 | 0 | 0 |
| Completed | 46 | 48 | 0 | 0 | 0 |
| Not completed | 24 | 14 | 0 | 0 | 0 |
| Withdrew: Relapsed and entered epoch 2 (e2) | 17 | 4 | 0 | 0 | 0 |
| Withdrew: Relapsed and did not enter e2 | 5 | 2 | 0 | 0 | 0 |
| Withdrew: Did not relapse;ended treatment (et) from epoch1 | 2 | 8 | 0 | 0 | 0 |
| Milestone | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|---|---|
| Started | 0 | 0 | 16 | 4 | 1 |
| Completed | 0 | 0 | 16 | 4 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
Relapse rate is defined as the percentage of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of \>=1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
| percentage of participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Epoch 1: Relapse Rate | 31.4 (21.76 to 43.03) | 9.7 (4.51 to 19.55) |
Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of \>=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period \[6 months\] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
| percentage of participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG |
|---|---|
| Epoch 2: Responder Rate | 100 (80.64 to 100.00) |
Defined as one or more of the following: an increase of \>=1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience CIDP worsening (defined as a \>=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); \>=4 points decrease in raw Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period). Participants are rounded off to nearest single decimal point.
| percentage of participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability | 54.4 (42.66 to 65.70) | 37.5 (26.01 to 50.59) |
Time to relapse is defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse. Participants who did not relapse were censored at their end of study.
| days | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Time to Relapse | NA (20 to 221) | NA (7 to 217) |
The Rasch-Built Overall Disability Scale (R-ODS) is a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participant with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (i.e, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion. The centile metric R-ODS score range is 0 to 100. Higher scores indicate better condition. The centile metric R-ODS score was used in the ANCOVA analysis. ANCOVA was used for the analysis.
| score on a scale | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS) | -6.1 ± 1.64 | -0.9 ± 1.69 |
An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
| Participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Any TEAE | 40 | 49 |
| Any Serious TEAE | 5 | 2 |
AE=any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g.,abnormal laboratory finding), symptom (e.g.,rash, pain, discomfort, fever, dizziness, etc.), disease (e.g.,peritonitis,bacteremia,etc.), outcome of death temporally associated with use of IP,considered causally related to the IP. SAE=untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, thromboembolic events, hemolytic anemia. Non-SAE=AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
| Participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Any IP-related TEAE | 19 | 38 |
| Any Serious IP-related TEAE | 5 | 1 |
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
| Participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| All AR/SAR | 27 | 41 |
| Serious AR/SAR | 5 | 1 |
AE: any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. SAE: an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. Participants can have more than one adverse event.
| events in participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Non-serious AEs | 144 | 340 |
| Serious AEs | 5 | 2 |
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
| causally related events in participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Casually Related Non-serious Adverse Events | 53 | 223 |
| Casually Related Serious Adverse Events | 5 | 1 |
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one temporally associated with infusion adverse event.
| events in participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Epoch 1: Number of Adverse Events (AEs) Temporally Associated With Infusions | 61 | 251 |
AR plus suspected AR: any AE that meets any of the criteria: AE considered by either investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following end of IP infusion, or AE for which causality assessment is missing or indeterminate. SAE: untoward medical occurrence that at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. Nonserious AE is AE that does not meet the criteria. Infusion per event = number of events / total number of infusions administered (started) to participants in analysis set. Participants can have more than one AR/suspected AR associated with infusion.
| events in participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Non-Serious AR/Suspected AR | 76 | 261 |
| Serious AR/Suspected AR | 5 | 1 |
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one TEAE associated with infusion.
| events in participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Epoch 1: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions | 149 | 342 |
AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. Treatment-emergent adverse events (TEAEs) are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.
| events in participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Epoch 1: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions | 20 | 141 |
| number of infusions | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Epoch 1: Number of Infusions in Participants for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs) | 1 | 3 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
| number of AEs/infusion | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Systemic Adverse Events | 0.20 | 0.34 |
| Local Adverse Events | 0.03 | 0.24 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
| number of AEs/participant | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Systemic AEs | 1.84 | 3.24 |
| Local AEs | 0.29 | 2.27 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
| number of AEs/1000 participant-year | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Systemic AEs | 4689.22 | 7341.52 |
| Local AEs | 727.01 | 5150.02 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
| number of AEs/infusion | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| IP-Related Systemic TEAE | 0.06 | 0.17 |
| IP-Related Local TEAE | 0.02 | 0.21 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
| number of AEs/participant | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| IP-related Systemic TEAE | 0.54 | 1.6 |
| IP-related Local TEAE | 0.21 | 2 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.
| number of AEs/1000 participant-year | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| IP-related Systemic TEAE | 1381.32 | 3615.98 |
| IP-related Local TEAE | 545.26 | 4529.1 |
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
| number of ARs/infusion | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Systemic Plus Suspected ARs | 0.09 | 0.20 |
| Local Plus Suspected ARs | 0.03 | 0.24 |
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
| number of ARs/participant | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Systemic Plus Suspected ARs | 0.80 | 1.94 |
| Local Plus Suspected ARs | 0.29 | 2.27 |
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
| number of ARs/1000 Participant year | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Systemic Plus Suspected ARs | 2035.63 | 4383.00 |
| Local Plus Suspected ARs | 727.01 | 5150.02 |
Number of participants who developed binding and/or neutralizing antibodies to rHuPH20 in Epoch 1 were reported. High-binding antibodies is defined as number of participants who had at least one anti-rHuPH20 antibody titer ≥1:160 during treatment.
| Participants | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia |
|---|---|---|
| Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) | 7 | 1 |
Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events regardless of causality in Epoch 2 was reported.
| Participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Any IP related TEAE | 11 | 3 | 1 |
| Any IP related serious TEAE | 0 | 0 | 0 |
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
| Participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Causally related AEs | 8 | 3 | 0 |
| Causally related SAEs | 0 | 0 | 0 |
An adverse reaction/suspected adverse reaction is defined as an Adverse Event that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion.
| Participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Any AR/SAR | 10 | 3 | 0 |
| Any Serious AR/SAR | 0 | 0 | 0 |
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one adverse event.
| events in participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Serious AEs | 0 | 0 | 0 |
| Non-serious AEs | 35 | 25 | 1 |
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
| events in participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Any TEAE | 23 | 0 | 0 |
| Any serious TEAE | 0 | 0 | 0 |
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one adverse event.
| events in participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Epoch 2: Number of Adverse Events (AEs) Temporally Associated With Infusions | 25 | 11 | 0 |
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one AR/SAR.
| events in participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| AR/SAR | 28 | 11 | 0 |
| Serious AR/SAR | 0 | 0 | 0 |
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one treatment-emergent systemic AEs.
| events in participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Epoch 2: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions | 35 | 25 | 1 |
AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. TEAEs are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.
| events in participants | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Epoch 2: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions | 0 | 0 | 0 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
| number of infusions | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG |
|---|---|---|
| Epoch 2: Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or Adverse Events (AEs) | 1 | 1 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set
| number of AEs/infusion | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Systemic AEs | 0.11 | 0.41 | 0.06 |
| Local AEs | 0 | 0 | 0 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
| number of AEs/participant | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Systemic AEs | 2.19 | 6.25 | 1.00 |
| Local AEs | 0 | 0 | 0 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
| number of AEs/1000 participant-year | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Systemic AEs | 4645.26 | 12806.80 | 2135.96 |
| Local AEs | 0 | 0 | 0 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set
| number of AEs/infusion | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| IP-related Systemic Adverse Events | 0.07 | 0.13 | 0 |
| IP-related Local Adverse Events | 0 | 0 | 0 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
| number of AEs/participant | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| IP-related Systemic Adverse Events | 1.44 | 2 | 0 |
| IP-related Local Adverse Events | 0 | 0 | 0 |
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.
| number of AEs/1000 participant-year | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| IP-related Systemic Adverse Events | 3052.6 | 4098.18 | 0 |
| IP-related Local Adverse Events | 0 | 0 | 0 |
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
| number of ARs/infusion | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Systemic plus Suspected ARs | 0.09 | 0.18 | 0 |
| Local plus Suspected ARs | 0 | 0 | 0 |
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
| number of ARs/participant | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Systemic plus Suspected ARs | 1.75 | 2.75 | 0 |
| Local plus Suspected ARs | 0 | 0 | 0 |
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
| number of ARs/1000 participant-year | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|
| Systemic plus Suspected ARs | 3716.21 | 5634.99 | 0 |
| Local plus Suspected ARs | 0 | 0 | 0 |
Defined as one or more of the following: a decrease of \>=1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience CIDP improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; \>=4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period \[6 months\] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
| percentage of participants | Epoch 2: E1: Placebo Relapse - E2: IGIV | Epoch 2: E1: HYQVIA Relapse - E2: IGIV |
|---|---|---|
| Epoch 2: Percentage of Participants With Clinically Meaningful Improvement in Functional Ability | 100 (80.64 to 100) | 100 (NA to NA) |
Collected over From the date of signing of the informed consent form up to the end of the study, approximately 74 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epoch 1: Placebo With rHuPH20 | 0/70 (0%) | 5/70 (7.1%) | 19/70 (27.1%) |
| Epoch 1: HYQVIA/HyQvia | 0/62 (0%) | 2/62 (3.2%) | 42/62 (67.7%) |
| Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | 0/16 (0%) | 0/16 (0%) | 11/16 (68.8%) |
| Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|---|---|
| Chronic inflammatory demyelinating polyradiculoneuropathyNervous system disorders | 4/70 | 0/62 | 0/16 | 0/4 | 0/1 |
| Cerebrovascular accidentNervous system disorders | 0/70 | 1/62 | 0/16 | 0/4 | 0/1 |
| Otitis media chronicInfections and infestations | 0/70 | 1/62 | 0/16 | 0/4 | 0/1 |
| ArrhythmiaCardiac disorders | 1/70 | 0/62 | 0/16 | 0/4 | 0/1 |
| Event | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia | Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG | Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG | Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C |
|---|---|---|---|---|---|
| Benign prostatic hyperplasiaReproductive system and breast disorders | 1/70 | 0/62 | 0/16 | 0/4 | 1/1 |
| HeadacheNervous system disorders | 8/70 | 8/62 | 6/16 | 2/4 | 0/1 |
| Abdominal pain upperGastrointestinal disorders | 0/70 | 0/62 | 0/16 | 1/4 | 0/1 |
| ChillsGeneral disorders | 0/70 | 1/62 | 0/16 | 1/4 | 0/1 |
| Ear painEar and labyrinth disorders | 0/70 | 0/62 | 0/16 | 1/4 | 0/1 |
| NasopharyngitisInfections and infestations | 1/70 | 1/62 | 0/16 | 1/4 | 0/1 |
| PainGeneral disorders | 0/70 | 0/62 | 0/16 | 1/4 | 0/1 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/70 | 3/62 | 0/16 | 1/4 | 0/1 |
| PyrexiaGeneral disorders | 1/70 | 7/62 | 1/16 | 1/4 | 0/1 |
| VomitingGastrointestinal disorders | 4/70 | 1/62 | 0/16 | 1/4 | 0/1 |
Epoch 1 safety analysis set included all participants who received any study treatment.
| Age, Continuous(years) | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia | Total |
|---|---|---|---|
| Mean | 53.9 ± 13.42 | 55.0 ± 14.26 | 54.4 ± 13.78 |
| Sex: Female, Male(Participants) | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia | Total |
|---|---|---|---|
| Female | 32 | 26 | 58 |
| Male | 38 | 36 | 74 |
| Ethnicity (NIH/OMB)(Participants) | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 9 | 23 |
| Not Hispanic or Latino | 46 | 47 | 93 |
| Unknown or Not Reported | 10 | 6 | 16 |
| Race (NIH/OMB)(Participants) | Epoch 1: Placebo With rHuPH20 | Epoch 1: HYQVIA/HyQvia | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 64 | 58 | 122 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 3 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Dec 2015 to primary completion in Feb 2022, 74 months.
Results were first posted in May 2023, 1 year 3 months after primary completion.
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Studies of the drugs tested here: Immunoglobulin G · Hyaluronoglucosaminidase · Immunoglobulins
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →