Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 20 study locations across 15 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03347422
The ClinicalTrials.gov registry entry for NCT03347422 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ, a Sanofi company, which has 14 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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
Similar trials for Cold Agglutinin Disease
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.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.