BIVV009-01 - Safety, Tolerability and Activity of BBIVV009 in Healthy Volunteers and Patients with Complement Mediated Disorders (BIVV009-01) Phase 1 Sanofi (Bioverativ) and Collaborators
Recruiting Last Updated Post December 18, 2019
Estimated Completion Date March 2021
BIVV020 - A Safety and Tolerability Study of BIVV020 in Adults with Cold Agglutinin Disease Phase 1 Sanofi Genzyme
Estimated Completion Date November 2021
BIVV009 - (Sutimlimab - press release May 14, 2020 ) A Study to Assess the Efficacy and safety of BIVV009 in Participants With Primary Cold Agglutinin Diseases Without A Recent History of Blood transfusion (Cadenza Study) Phase 3 Sanofi Genzyme
Active, Not Recruiting
Estimated Completion Date December 2021
We are writing to introduce ourselves and to share some exciting cold agglutinin disease (CAD) news.
Apellis is a development stage, global biopharmaceutical company that was established 10 years ago to combine courageous science, creativity, and compassion to deliver life-changing medicines for a broad range of serious diseases.
APL-2 - Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 (Pegcetacoplan) in Patients With wAIHA or CAD (Plaudit Study) Phase 2
Apellis Pharmaceuticals https://clinicaltrials.gov/ct2/show/NCT04269551
Active, Not Recruiting Last Updated Post February 7, 2020
Estimated Completion Date December 2020
A Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen.
Estimated end of recruitment: Oct 2021.
Subjects who complete 24 weeks of treatment will be invited to participate in the Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA
Estimated end of recruitment: Apr 2022
Please click on link to clinicaltrials.gov for points-of-contact for each of these studies.
The purpose of the current study is to assess the efficacy and safety/tolerability of two dose regimens of RVT-1401 (currently known as IMVT-1401) in the treatment of patients who have failed or not tolerated at least one prior treatment for WAIHA. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in IgG and other exploratory biomarkers.
https://ascendwaihastudy.com/ and the trial video below.
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