NCT03347422

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (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 (\>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without 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 primary CAD.

Detailed description

The planned total study duration per participant was approximately 1.5 to 2.5 years.

Conditions

• Cold Agglutinin Disease

Interventions

Type	Name	Description
DRUG	sutimlimab (BIVV009)	Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)
DRUG	placebo	Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.)

Timeline

• Start date: 2018-03-17
• Primary completion: 2021-12-03
• Completion: 2021-12-03
• First posted: 2017-11-20
• Last updated: 2022-12-23
• Results posted: 2022-12-23

Locations

53 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