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
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.
Timeline
- Start
- 2018-03-17
- Primary completion
- 2021-12-03
- Completion
- 2021-12-03
Outcome
Met primary endpoint
registry NUMBER BIVV009: 72.7 (49.8 to 89.3) percentage of participants NCT03347422 ↗
registry analysis (superiority test); BIVV009 vs Placebo; p <0.001; Odds Ratio (OR) 15.94 (95% CI 2.88 to 88.04) NCT03347422 ↗
release “Phase 3 data from the CADENZA study met the primary composite endpoint with statistical significance; secondary endpoint data were clinically meaningful” sanofi.com ↗
release “Seventy-three percent (n=16) of patients treated with sutimlimab met the primary composite endpoint” sanofi.com ↗
Publications
- Roth A, Broome CM, Barcellini W, Jilma B, Hill QA, Cella D, Tvedt THA, Yamaguchi M, Lee M, Shafer F, Wardecki M, Jiang X, Patel P, Joly F, Weitz IC. Sutimlimab provides clinically meaningful improvements in patient-reported outcomes in patients with cold agglutinin disease: Results from the randomised, placebo-controlled, Phase 3 CADENZA study. Eur J Haematol. 2023 Mar;110(3):280-288. doi: 10.1111/ejh.13903. Epub 2022 Dec 9.
- Roth A, Berentsen S, Barcellini W, D'Sa S, Jilma B, Michel M, Weitz IC, Yamaguchi M, Nishimura JI, Vos JMI, Storek M, Wong N, Patel P, Jiang X, Vagge DS, Wardecki M, Shafer F, Lee M, Broome CM. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022 Sep 1;140(9):980-991. doi: 10.1182/blood.2021014955.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sutimlimab | Monoclonal antibody | 6.5 g | Intravenous |
| Subject | sutimlimab | Monoclonal antibody | 7.5 g | Intravenous |