sutimlimab: Clinical Trials

3 completed, 1 active not recruiting. 3 Phase 3.

By phase and status

Phase	Trials	Status
Phase 3	3	Completed 3

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan sutimlimab - Cold Agglutinin Disease	Phase 3	Completed	Sanofi	7	2021-11-11	2025-09-15
Cold Agglutinin Disease Real World Evidence Registry Sutimlimab - Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)		Active not recruiting	RECORDATI GROUP	429	2019-12-12	2026-04-22
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 sutimlimab (BIVV009), placebo - Cold Agglutinin Disease	Phase 3	Completed	Bioverativ, a Sanofi company	42	2018-03-17	2022-12-23
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) BIVV009 - Agglutinin Disease, Cold	Phase 3	Completed	Bioverativ, a Sanofi company	24	2018-03-05	2022-10-31

Conditions studied

Anemia, Hemolytic, Autoimmune (4)

Sponsors

Bioverativ, a Sanofi company (2)  ·  RECORDATI GROUP (1)  ·  Sanofi (1)

Countries

Japan (4)  ·  Austria (3)  ·  France (3)  ·  Germany (3)  ·  Italy (3)  ·  Spain (3)  ·  United Kingdom (3)  ·  United States (3)  ·  Australia (2)  ·  Belgium (2)  ·  Canada (2)  ·  Israel (2)  ·  Netherlands (2)  ·  Norway (2)

Top investigators

Ignacio Alvarez Rojo (1)

Results publications

PMID 33826820, PMID 34778998, PMID 35687757, PMID 35999387, PMID 36403132, PMID 37246953, PMID 37459203

NIH funding

2017 (2)