NCT03347396

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)

A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bioverativ, a Sanofi company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to \>= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.

Conditions

• Agglutinin Disease, Cold

Interventions

Type	Name	Description
DRUG	BIVV009	Sutimlimab was administered as intravenous (IV) infusion.

Timeline

• Start date: 2018-03-05
• Primary completion: 2021-10-05
• Completion: 2021-10-05
• First posted: 2017-11-20
• Last updated: 2022-10-31
• Results posted: 2022-10-31

Locations

49 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Spain, United Kingdom

Regulatory

• FDA-regulated drug study