Sickle Cell Disease Clinical Trial
Official title:
A Phase 3, Prospective, Randomized, Double-Blind, Placebo Controlled, Multi-center Study of SC411 for Sickle Cell Disease
The objective of this study is to assess the efficacy of SC411 in reducing the number of sickle cell crisis (SCC) events in sickle cell disease (SCD) subjects receiving SC411 compared to those subjects receiving placebo.
This Phase 3, prospective, randomized, double-blinded, placebo-controlled, multi-center study
will enroll approximately 210 subjects at up to 70 sites in the United States. Participation
will consist of a Screening Period, followed by a minimum 12-month Treatment Period. SC411 is
administered orally as a soft gel mini capsule.
This study will enroll subjects aged ≥5 to ≤17 years who have a diagnosis of SCD that
includes the phenotypes hemoglobin SS homozygous (HbSS), hemoglobin SC (HbSC), and hemoglobin
S/β°-thalassemia (HbS/ β°-thalassemia); and have had at least 2 but no more than 10
documented SCC events (as defined above) within 12 months prior to the Screening Visit.
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