A Phase 3 interventional study of IPP-201101 and Placebo in Lupus Erythematosus, Systemic, sponsored by ImmuPharma. Completed at 30 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-11.
Sponsored by ImmuPharma · Phase 3, Interventional, and Treatment
This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's enrollment of 202 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →ImmuPharma is the lead sponsor of 2 studies on the registry; none are open to participants now.
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.
Exclusion Criteria:
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
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.
Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Drug: IPP-201101 · Other: Standard of Care
Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Drug: Placebo · Other: Standard of Care
Also known as: Lupuzor, regiremod
Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52
A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline. The decrease of 4 points of the SRI is considered as better ouctome.
Time frame: At week 52
| Milestone | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC |
|---|---|---|
| Started | 101 | 101 |
| Completed | 77 | 76 |
| Not completed | 24 | 25 |
A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline. The decrease of 4 points of the SRI is considered as better ouctome.
| percentage of patient responder | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC |
|---|---|---|
| Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52 | 52.5 | 44.6 |
EU patients who had an assessment of "Yes" for anti-dsDNA at randomization and responders at week 52
| percentage of patient responder | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC |
|---|---|---|
| Proportion of Responders of EU Patients Having Anti-dsDNA ar Randomization | 61.5 | 47.3 |
Collected over Adverse event collection was done during 52 weeks for each patient.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IPP-201101 200-mcg Plus SOC | 0/101 (0%) | 13/101 (12.9%) | 94/101 (93.1%) |
| PLACEBO Plus SOC | 0/101 (0%) | 16/101 (15.8%) | 96/101 (95%) |
| Event | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC |
|---|---|---|
| PregnancyPregnancy, puerperium and perinatal conditions | 1/101 | 3/101 |
| HypertensionVascular disorders | 0/101 | 2/101 |
| AnemiaBlood and lymphatic system disorders | 2/101 | 1/101 |
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 1/101 | 2/101 |
| Deep vein thrombosisVascular disorders | 0/101 | 1/101 |
| Mesothelioma malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/101 | 0/101 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/101 | 0/101 |
| face EdemaGeneral disorders | 1/101 | 0/101 |
| depressionPsychiatric disorders | 0/101 | 1/101 |
| Pelvic fluid collectionReproductive system and breast disorders | 1/101 | 0/101 |
| Event | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 20/101 | 28/101 |
| Urinary tract infectionInfections and infestations | 23/101 | 10/101 |
| HeadacheNervous system disorders | 12/101 | 17/101 |
| ArthritisMusculoskeletal and connective tissue disorders | 15/101 | 14/101 |
| AlopeciaSkin and subcutaneous tissue disorders | 12/101 | 13/101 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/101 | 13/101 |
| RashSkin and subcutaneous tissue disorders | 12/101 | 8/101 |
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 2/101 | 10/101 |
| Back painMusculoskeletal and connective tissue disorders | 9/101 | 9/101 |
| LeukopeniaRespiratory, thoracic and mediastinal disorders | 8/101 | 7/101 |
| Age, Categorical(Participants) | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 101 | 101 | 202 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC | Total |
|---|---|---|---|
| Female | 96 | 92 | 188 |
| Male | 5 | 9 | 14 |
| Race/Ethnicity, Customized(Participants) | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC | Total |
|---|---|---|---|
| Not Hispanic or Latino | 88 | 84 | 172 |
| Hispanic or Latino | 13 | 19 | 32 |
| Region of Enrollment(Participants) | IPP-201101 200-mcg Plus SOC | PLACEBO Plus SOC | Total |
|---|---|---|---|
| Hungary | 9 | 15 | 24 |
| United States | 36 | 37 | 73 |
| Czechia | 10 | 5 | 15 |
| Poland | 12 | 20 | 32 |
| France | 3 | 4 | 7 |
| Mauritius | 27 | 22 | 49 |
| Germany | 3 | 1 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2015 to primary completion in Jan 2018, 34 months.
Results were first posted in Apr 2019, 1 year 3 months after primary completion.
Of 53 phase 3 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 84. This study's 34 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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