Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Low Risk

Score: 15/100

Failure Rate

6.3%

1 terminated/withdrawn out of 16 trials

Success Rate

93.3%

+6.8% vs industry average

Late-Stage Pipeline

50%

8 trials in Phase 3/4

Results Transparency

64%

9 of 14 completed trials have results

Key Signals

9 with results

Enrollment Performance

Analytics

Phase 3
7(43.8%)
Phase 1
6(37.5%)
Phase 2
2(12.5%)
Phase 4
1(6.3%)
16Total
Phase 3(7)
Phase 1(6)
Phase 2(2)
Phase 4(1)

Activity Timeline

Global Presence

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Clinical Trials (16)

Showing 16 of 16 trials
NCT04658472Phase 2Completed

Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Role: lead

NCT04770935Phase 1Completed

To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

Role: lead

NCT04269551Phase 1Completed

A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease

Role: lead

NCT04161495Phase 3Completed

A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A

Role: lead

NCT04802057Phase 1Terminated

Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088

Role: lead

NCT04759131Phase 3Completed

Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A

Role: lead

NCT04669600Phase 2Completed

A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)

Role: lead

NCT04644575Phase 3Active Not Recruiting

Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A

Role: lead

NCT03275454Phase 1Completed

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP)

Role: lead

NCT03347422Phase 3Completed

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion

Role: lead

NCT03347396Phase 3Completed

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)

Role: lead

NCT02502903Phase 1Completed

Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders

Role: lead

NCT03205163Phase 1Completed

A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)

Role: lead

NCT02234323Phase 3Completed

An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

Role: lead

NCT03093480Phase 4Completed

A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)

Role: lead

NCT02234310Phase 3Completed

Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B

Role: lead

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