A Phase 1 interventional study of BIVV009 6.5 grams and BIVV009 7.5 grams in Purpura, Thrombocytopenic, Idiopathic, sponsored by Bioverativ, a Sanofi company. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-18.
Sponsored by Bioverativ, a Sanofi company (part of Sanofi) · Phase 1, Interventional, and Treatment
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Among 110 studies in Purpura, Thrombocytopenic, Idiopathic with a site in United States — 18 open to participants now, 22 under way, 9 of them phase 3. Purpura, Thrombocytopenic, Idiopathic · United States.
Among the 110 studies in Purpura, Thrombocytopenic, Idiopathic with a site in United States, this one is the 78th largest by enrollment of the 94 interventional ones that give a count, is one of 2 that started in 2017, is one of 15 in phase 1, and was the 59th registered.
504 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 159 are open to participants now.
Browse Purpura, Thrombocytopenic, Idiopathic studies →18 of the 110 studies in Purpura, Thrombocytopenic, Idiopathic with a site in United States are open now. Recruiting first, the newest first:
Amgen · Sites in United States
Ages 18–100
Novartis Pharmaceuticals · Sites in United States
Ages 18+
CRISPR Therapeutics AG · Sites in United States, Germany, Spain
Ages 18+
Incyte Corporation · Sites in United States, Australia, France and 4 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 103 Purpura, Thrombocytopenic, Idiopathic studies recruiting now, 49 (48%) set no upper age limit and 42 (41%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
110 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 43 · Phase 3 33 · Phase 4 2
First in 1999; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 58 across 377 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Median enrollment 42 across the 94 interventional studies, 97 across the 15 observational. Of the 80 that completed or were terminated, 46 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
79 of 110 have an industry lead sponsor. The 10 most frequent:
This study is registered under Bioverativ, a Sanofi company, one of the names counted as Sanofi. Under that name alone:
Bioverativ, a Sanofi company is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Sanofi has 8 studies filed under Purpura, Thrombocytopenic, Idiopathic — fewer than ten, so there is no comparison to draw.
9 of the studies in Purpura, Thrombocytopenic, Idiopathic with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07059000Phase 3Kedrion S.p.A.A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP) | 2026-12 |
| NCT04812925Phase 3argenxA Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | 2027-10 |
| NCT07007962Phase 3SanofiStudy to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment | 2027-11-05 |
| NCT07083960Lakefront Biotherapeutics West LLCOM336 in Autoimmune Cytopenias | 2026-12 |
| NCT07786077Novartis PharmaceuticalsA Study of Patients' Preferences for Primary Immune Thrombocytopenia Treatment | 2026-12-15 |
Add all 9 to your calendar (.ics) → With an account.
Among the 110 studies in Purpura, Thrombocytopenic, Idiopathic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia.
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.
Part A:
Part B:
Exclusion Criteria:
Part A:
Part B:
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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).
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.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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 condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
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.
Participants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009 intravenous (IV) infusion and participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009 every 2 weeks for approximately 21 weeks in Part A (based on time to complete 11 doses of study drug). There will be a 9-week safety follow-up/washout period after administration of the last dose of study drug in Part A. Participants who have been shown to benefit from BIVV009 treatment during Part A, will receive BIVV009 (based on weight) biweekly for up to 52 weeks of BIVV009 after Last Patient In (LPI) in part B.
Drug: BIVV009 6.5 grams · Drug: BIVV009 7.5 grams
Participants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009.
Participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009.
Incidence of Treatment-Emergent Adverse Events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 97 weeks
Number of Participants With Premature Study Terminations
Number of participants with premature study terminations will be assessed.
Time frame: Approximately 97 weeks
Number of Participants With Clinical Laboratory Abnormalities
Clinical laboratory abnormalities including one or more specific target-organs for toxicity of BIVV009, abnormalities in D-dimer, thrombin-anti-thrombin assay, and Systemic Lupus Erythematosus (SLE) panel.
Time frame: Approximately 97 weeks
Part A: Change From Baseline in Peripheral Blood Platelet Count at Part A End of Treatment (A-EOT)
Change from baseline in peripheral blood platelet count at A-EOT will be assessed.
Time frame: Baseline and A-EOT (Day 147)
Part A: Change From Baseline in Peripheral Blood Platelet Count during BIVV009 Treatment
Change from baseline in peripheral blood platelet count during BIVV009 treatment will be assessed.
Time frame: Baseline up to Day 147
Part A: Number of Participants who are independent from using combination Immune Thrombocytopenia (ITP) therapy during A-EOT but receive combination ITP therapy after A-EOT
Number of participants who are independent from using combination ITP therapy during A-EOT but receive combination ITP therapy after A-EOT will be assessed.
Time frame: Day 147 (A-EOT) up to Day 196 (EOS)
Part A: Number of Participants who Achieve Complete Response Through A-EOT
Complete response (CR) is defined as a platelet count greater than or equal to (\>=) 100\*10\^9/liter (L) measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits.
Time frame: Up to Day 147
Part A: Number of Participants who Achieve Response Through A-EOT
Response or Better: Response (R) is defined as a platelet count \>= 30\*10\^9/L and a greater than 2-fold increase from baseline measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits; and CR: A platelet count \>=100\*10\^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits.
Time frame: Up to Day 147
Part A: Duration of Complete Response per Each CR
Duration of CR is defined as the number of consecutive days in which a patient's peripheral blood platelet count is \>= 100\*10\^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy.
Time frame: Up to Day 196
Part A: Duration of Response per Each Response
Duration of response is defined as the number of consecutive days in which a patient's peripheral blood platelet count is \>= 30\*10\^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy.
Time frame: Up to Day 196
Part A: Time to First Platelet Response
Time to first platelet response is defined as greater than or equal to 30\*10\^9/L, 50\*10\^9/L, 100\*10\^9/L (confirmed by a consecutive platelet response at least 7 days apart).
Time frame: Up to Day 196
Part A: Number of Participants who Report Loss of Response Among Those who Achieve Response
Number of participants who report loss of response among those who achieve response will be reported. For a participant with a response (R), the loss of the response is defined as a platelet count \< 30\*10\^9/L measured on 2 consecutive occasions at least 1 day apart, or a less than 2-fold increase in platelet count from baseline measured on 2 consecutive occasions at least 1 day apart, or the presence of bleeding, or use of the combination ITP therapy.
Time frame: Up to Day 196
Part A: Number of Participants who Report Loss of Complete Response Among Those who Achieve Complete Response
Number of participants who report loss of complete response among those who achieve complete response will be reported. For a participant with a complete response (CR), loss of complete response is defined as a platelet count less than (\<) 100\*10\^9/L measured on 2 consecutive occasions more than 1 day apart and/or the presence of bleeding or use of the combination ITP therapy.
Time frame: Up to Day 196
Part B: Change From Baseline in Peripheral Blood Platelet Count to B-EOT
Change from baseline (Part B) in peripheral blood platelet count to B-EOT will be assessed.
Time frame: Baseline up to 52 weeks
Part B: Number of Participants who Achieve CR and the Lack of Platelet Transfusions or Other ITP Therapy During Treatment Period
Number of participants who achieve CR and the lack of platelet transfusions or other ITP therapy during Part B treatment period will be reported. Complete response (CR): A platelet count \>= 100\*10\^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding on and through these two visits and the lack of combination ITP therapy on and through these two visits.
Time frame: Up to 52 weeks
Part B: Number of Participants who Achieve Response Through Part B End of Treatment (B-EOT)
Number of participants who achieve response through B-EOT will be reported.
Time frame: Up to 52 weeks
Part B: Duration of Complete Response per Each CR
Duration of CR is defined as the number of consecutive days in which a participant's peripheral blood platelet count is \>= 100\*10\^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy.
Time frame: Up to 52 weeks
Part B: Duration of Response per each Response
Duration of response is defined as the number of consecutive days in which a participant's peripheral blood platelet count is \>= 30\*10\^9/L and the absence of bleeding, and the lack of platelet transfusions or other ITP therapy.
Time frame: Up to 52 weeks
Part B: Number of Participants who achieve a platelet count >= 100*10^9/L on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT
Number of participants who achieve a platelet count \>= 100\*10\^9/L on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT will be assessed.
Time frame: Up to 52 weeks
Part B: Number of Participants who achieve a platelet count >=30*10^9/L, a >2-fold increase from baseline measured on 2 consecutive occasions at least 7 days apart, have absence of bleeding on and through these two visits, use any combination ITP therapy
Number of participants who achieve a platelet count \>= 30\*10\^9/L and a greater than (\>) 2-fold increase from baseline measured on 2 consecutive occasions at least 7 days apart and have the absence of bleeding on and through these two visits and use any combination ITP therapy through B-EOT will be assessed.
Time frame: Up to 52 weeks
Part B: Number of Participants who do not Require Other Immune Thrombocytopenia (ITP) Therapy (non-transfusion) During the Part B Treatment Period
Number of Participants who do not require other ITP therapy (non-transfusion) following the last BIVV009 dose will be assessed.
Time frame: Up to 52 weeks
Part B: Number of Participants who do not Require Platelet Transfusions During the Part B Treatment Period
Number of Participants who do not require platelet transfusions during the Part B treatment period will be reported.
Time frame: Up to 52 weeks
Part B: Number of Participants who Experience any Bleeding Episode, Bleeding by Grade or Serious Bleeding
Number of participants who experience any bleeding episode, bleeding by grade or serious bleeding according to the International Working Group (IWG) Bleeding Assessment Tool (BAT) will be reported.
Time frame: Up to 52 weeks
Plasma Concentrations of BIVV009
Plasma concentrations of BIVV009 will be assessed.
Time frame: Approximately 97 weeks
Maximum Observed Plasma Concentration (Cmax) of BIVV009
Maximum observed concentration of BIVV009 in plasma will be assessed.
Time frame: Approximately 97 weeks
Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIVV009
Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIVV009 will be assessed.
Time frame: Approximately 97 weeks
Area Under the Concentration-time Curve (AUC) From Hour 0 to the last quantifiable time point (AUC [0-t]) of BIVV009
AUC (0-t) is the area under the Concentration-time curve (AUC) from hour 0 to the last quantifiable time point of BIVV009.
Time frame: Approximately 97 weeks
Number of Participants With Anti-drug antibodies (ADAs) Against BIVV009
Blood samples will be collected to determine number of participants with anti-drug antibodies (ADAs) against BIVV009.
Time frame: Up to 97 weeks
Complement System Classical Pathway Levels as Measured by WIESLAB Assay
Inhibition by BIVV009 of the complement system classical pathway measured by the WIESLAB assay.
Time frame: Up to 97 weeks
Total Complement (CH50) Levels
Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity. It will be assessed using complement assays.
Time frame: Up to 97 weeks
Total Complement Factor C4 Levels
Total C4 Levels will be assessed in plasma using complement assays.
Time frame: Up to 97 weeks
C1 Complex Components: C1q
C1q Levels will be assessed in plasma using complement assays.
Time frame: Up to 97 weeks
Thrombopoietin Level
Thrombopoietin level will be assessed in plasma using complement assays.
Time frame: Up to 97 weeks
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Aug 2017 to primary completion in Feb 2021, 42 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sutimlimab
Purpura, Thrombocytopenic, Idiopathic →
Bioverativ, a Sanofi company →