Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIVV009 · 1 trial · 1 indication
A participant was considered a responder: if he or she did not receive a blood transfusion from Week 5 through Week 26 (end of treatment in Part A) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, the participant's hemoglobin (Hgb) level must meet either of the following criteria: Hgb level \>= 12 grams per deciliter (g/dL) at the treatment assessment endpoint (defined as the average of the values from the Week 23, 25, and 26 visits), or Hgb increased \>= 2 g/dL from baseline (defined as the last Hgb value before administration of the first dose of study drug) at treatment assessment endpoint. Percentage of responders was calculated together with a 95% exact Clopper-Pearson confidence interval (CI).
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from the first investigational medicinal product \[IMP\] administration in Part B to the last IMP administration + 9 weeks follow up period).
| Arm | Type | Description |
|---|---|---|
| BIVV009 | EXPERIMENTAL | Participants with primary CAD who had a recent history of transfusion (defined as at least 1 transfusion during the last 6 months prior to screening) received an intravenous (IV) infusion of BIVV009 6.5 grams (g) (if body weight was less than \[\<\] 75 kilograms \[kg\]) or BIVV009 7.5 g (if body weight was greater than or equal to \[\>=\] 75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) could continue to receive BIVV009 in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks. All participants who completed Part A elected to continue in Part B. |
| Name | Type | Description |
|---|---|---|
| BIVV009 | DRUG | Sutimlimab was administered as intravenous (IV) infusion. |
Inclusion Criteria: * Body weight of \>= 39 kg at screening. * Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific DAT strongly positive for C3d; d) Cold agglutinin titer \>= 64 at 4 degre...
BIVV009 is an investigational drug being studied for the treatment of cold agglutinin disease, a condition where the immune system attacks and destroys red blood cells at low temperatures. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
BIVV009 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 3 clinical trials for cold agglutinin disease.
BIVV009 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The drug is being studied for the treatment of cold agglutinin disease, and its Phase 3 trial has been completed.
BIVV009 has one completed Phase 3 clinical trial with the identifier NCT03347396, known as the Cardinal Study. This trial assessed the efficacy and safety of BIVV009 in participants with primary cold agglutinin disease who had a recent history of blood transfusion. The study enrolled 24 participants.
Yes, BIVV009 is also known as sutimlimab. The clinical trial NCT03347396, which studied BIVV009, is titled 'A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study).'