Clinical Trial

Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype

Study acronym: RESCUE
Not Yet Recruiting Phase 2
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Summary
SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children. The purpose of this study is to compare the effects of senicapoc to placebo in patients with sickle cell disease that have had fewer than 2 acute sickle-related painful crises per year over the preceding 2 years, and have a predominantly hemolytic phenotype, defined as presence or history of at least one hemolytic complication and a baseline Hb of 9 g/dL or less, despite receiving hydroxyurea (an oral drug used for treatment of sickle cell disease) as standard of care. Participants will take senicapoc or matching placebo daily and continue on hydroxyurea as prescribed for up to 24 weeks.
Trial Details
NCT Number NCT07282210
Lead Sponsor Biossil Inc.
Conditions Sickle Cell Disease, Sickle Cell Anaemia, Sickle Cell Anemia
Enrollment 105 participants
Start Date 2026-01
Primary Completion 2028-11 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-15