A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients with Autoimmune Hemolytic Anemia and Immune Thrombocytopenia
Kezar Life Sciences, Inc is evaluating an investigational drug in a clinical research study to determine whether it can help improve the symptoms of Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP).
We are currently looking for eligible participants that have been diagnosed by a physician with anemia or low platelets from AIHA, ITP, or Evans Syndrome to be enrolled into the Phase 2 MARINA study at multiple clinical trial sites in the United States. Participants with warm AIHA, cold agglutinin disease, and mixed AIHA may be eligible to participate.
All participants in the study will receive the investigational drug, KZR-616 given once weekly through an injection (a shot) 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 study site for an additional 12 weeks. Study participants may have the option to enroll in an extension study.
All study assessments, study drugs, and procedures will be provided at no cost to participants.
The aim of the current study is to investigate whether treatment with KRZ-616 can improve red blood cell and/or platelet counts and help improve the symptoms of AIHA/ITP.
Autoimmune Hemolytic Anemia is a group of disorders caused by the immune system attacking red blood cells, which carry oxygen throughout the body. People may present with no symptoms or with fatigue, shortness of breath, or pale skin. There are no approved treatments for AIHA and patients may be treated with corticosteroids, immunosuppressants, or immune globulin.
Immune Thrombocytopenia is a bleeding disorder caused by the immune system attacking platelets, which are necessary for the clotting of blood. Patients may present with no symptoms or with fatigue or with easy or excessive bruising, bleeding under the skin appearing as pinpoint-sized reddish-purple spots, bleeding from mucosal membranes like the gums or nose, or blood in urine or stools. ITP may be treated with drugs that increase platelet production or affect the immune response with corticosteroids, immunosuppressants, or immune globulin.
KZR-616, which is the investigational drug in this study, is a selective immunoproteasome inhibitor. The immunoproteasome is found inside cells of the immune system and is responsible for breaking down various proteins in these cells. By blocking protein breakdown, laboratory research has indicated that KZR-616 can reduce inflammation and decrease autoimmune processes that underly diseases like AIHA and ITP. We believe that KZR-616 may have broad therapeutic potential across multiple autoimmune diseases, while having the potential to avoid immunosuppression.
Eligible participants will need to either visit the study site or have a home nurse visit once a week during the 13-week treatment period and will have to visit the study site once a month during the 12-week follow up period.
To be considered eligible for the MARINA study, participants must:
Additional sites to be opened, please check back for updates.