CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
BIVV009drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03347396
NCT03347396Phase 3Completed
CompareCT.gov

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

Bioverativ, a Sanofi company·interventional·Posted Nov 20, 2017·Updated Oct 31, 2022

In Brief

A Phase 3 clinical trial evaluating BIVV009 for Agglutinin Disease, Cold. Completed, enrolled 24 participants across 49 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgglutinin Disease, Cold
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 20, 2017
Enrollment StartMar 5, 2018
Primary CompletionOct 5, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.6 years ago

Interventions

BIVV009drug

Sutimlimab was administered as intravenous (IV) infusion.