Phase 3 Trial of Luspatercept Begins in U.S.


May 6, 2016 – Celgene in partnership with Acceleron is currently conducting a Phase 3 study of the protein luspatercept in beta-thalassemia called The BELIEVE Study.

Previous studies indicate that luspatercept helps increase the production of mature red blood cells. In a Phase 2 study of adult patients with beta-thalassemia, luspatercept was shown to increase hemoglobin levels and to decrease transfusion requirements and liver iron concentration.

The global Phase 3 study will compare outcomes in patients treated with luspatercept versus placebo. The study will enroll 300 adult patients who require regular blood transfusions due to beta-thalassemia. The first trial site has already begun to enroll patients in Los Angeles. Additional trial sites are expected to open in the near future in the following locations: (1) Oakland, CA; (2) Chicago, IL; (3) Boston, MA; (4) New York, NY; (5) Philadelphia, PA.

Further information about this study can be found at: https://clinicaltrials.gov/ct2/show/study/NCT02604433?term=luspatercept&rank=1&show_locs=Y#locn

A brochure can also be downloaded by clicking here.

The Cooley’s Anemia Foundation provides information on select clinical trials that may be of interest to the thalassemia population. This information is provided for educational purposes only and does not imply an endorsement of any trial. Patients who are considering participating in a clinical trial and do not know what questions to ask may want to consult with CAF Patient Outreach Director Sandy Gilbert (sgilbert@thalassemia.org) who can help them determine what questions they should ask the investigators to determine if a trial is right for them.

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