Kezar Life Sciences, Inc is now enrolling MARINA, a phase 2 study evaluating KZR-616, a selective immunoproteasome inhibitor in patients with Autoimmune Hemolytic Anemia (AIHA), including those diagnosed with cold agglutinin disease (CAD).

https://clinicaltrials.gov/ct2/show/NCT04039477 


The MARINA study is currently recruiting at multiple clinical trial sites in the United States. The trial is to evaluate KZR-616 to see if it can help improve AIHA. All participants in the study will receive KZR-616 once weekly through an injection at the clinic or in their home by a certified nurse for a period of 13 weeks. 


There will be a follow-up period requiring monthly visits to the clinic for an additional 12 weeks. Study participants have the option of enrolling in an extension study to continue KZR-616 longer than 13 weeks.


All study assessments, study drug, and procedures will be provided at no cost to participants.


If you are interested in participating or have any questions about the study, please email clinicaltrials@kezarbio.com or visit www.kezarlifesciences.com/MARINAstudy.

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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

http://clinicaltrials.gov/ct12/show/NCT02502903

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

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 

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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

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