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NCT03347422 · ClinicalTrials.gov registry record · Phase 3
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 study of Cold Agglutinin Disease, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
- 20
- Study locations
NCT03347422: Completed Phase 3 study of Cold Agglutinin Disease, sponsored by Bioverativ, a Sanofi company.
NCT03347422 is a Phase 3 study of Cold Agglutinin Disease that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 42 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03347422, a Phase 3 study of Cold Agglutinin Disease, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
A participant was considered a responder: if he or she did not receive blood transfusion from Week 5 through Week 26 (end of treatment) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, participant's hemoglobin (Hgb) level must have increased to \>=1.5 grams per deciliter (g/dL) from baseline (defined as last Hgb value before administration of first dose of study drug) at treatment assessment timepoint (defined as average of values from the Week 23, 25,
Conditions Studied
Interventions
- DRUG placebo
- DRUG sutimlimab (BIVV009)
Study Locations (20)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
New York
- Montefiore Medical Center - New York
- New York Medical College at Westchester Medical Center - Valhalla
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Victoria
- Ballarat Oncology & Haematology - Ballarat
- Monash Medical Centre - Clayton
Other
- Medical University of Vienna - Vienna
- ZNA Stuivenberg - Antwerp
Arizona
- Arizona Oncology Associates PC - Tucson
California
- USC/Keck School of Medicine - Los Angeles
District of Columbia
- Georgetown University Medical Center - Georgetown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-03-17 |
| Est. Completion | 2021-12-03 |
| Phase | Phase 3 |
What the finished NCT03347422 record still lists
NCT03347422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Cold Agglutinin Disease appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT03347422 names 20 study sites across 15 states, led by Massachusetts, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03347422 about?
NCT03347422 is a clinical study titled "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". 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 b...
What is the current status of trial NCT03347422?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2018-03-17. Estimated completion is 2021-12-03.
What conditions does trial NCT03347422 study?
This clinical trial studies the following conditions: Cold Agglutinin Disease.
What interventions are being tested in trial NCT03347422?
The interventions under investigation include: placebo (DRUG), sutimlimab (BIVV009) (DRUG).
Who is sponsoring clinical trial NCT03347422?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03347422 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03347422's enrollment target sits among peer trials
42 1877th of 2000 higher than 124 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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