clinical trials

BIVV020 - A Safety and Tolerability Study of BIVV020 in Adults with Cold Agglutinin Disease Phase 1 Sanofi Genzyme

https://clinicaltrials.gov/ct2/show/NCT04269551 

Recruiting 

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
https://clinicaltrials.gov/ct2/show/NCT03347422
Active, Not Recruiting
Estimated Completion Date December 2021 

Efficacy, Safety and Pharmacokinetics of Rilizabrutinib in Patients with Warm Autoimmue Hemolytic Anemia (wAIHA) This is a single group treatment, Phase 2 open-label, study to evaluate the efficacy, safety and pharmacokinetics of rilizabrutinib in adult patients with wAIHA.

ACT17209 - ClinicalTrials.gov 

As of September 29, 2021 Active, Not Recruiting YET

Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmunce Hemolytic Anemia (wAIHA).  Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA Part B: To evaluate the efficacy of the selected dose in adults with wAIHA 

ACT16832 - ClinicalTrials.gov

Active, Recruiting

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.  

Read Here for More:

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

The pivotal study is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of iopofosine I-131. The study will enroll 50 WM patients. Patients in the study will receive up to four doses of iopofosine I-131 over two cycles (cycle one days 1, 15, and cycle two days 57, 71). The primary endpoint of the study is response rate as defined as a partial response (a minimum of a 50% reduction in the biological marker IgM) or better in patients that receive a minimum total body dose of 60 mCi with secondary endpoints of treatment free survival, duration of response and progression free survival. An independent data monitoring committee (iDMC) will perform an interim safety and futility evaluation on the first 10 patients enrolled. The assessment will occur patient by patient and will conclude after the tenth patient is evaluated; there is no planned study stoppage. The study will include WM patients who have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitor failed or suboptimal response patients. 

To learn more about the clinical study please visit CLOVER-WaM Study (wmclinicaltrial.com).

Study of CLR 131 in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia - ClinicalTrials.gov

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.

https://clinicaltrials.gov/ct2/show/NCT03764618;

Active, Recruiting.

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

https://clinicaltrials.gov/ct2/show/NCT04138927

Active, Recruiting.

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.