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

Testing SIL-8301 for safety and effectiveness in sickle cell disease.

Recruiting
16-35 years
All
Phase 2

This study is testing a medicine called SIL-8301 (senicapoc) for people with sickle cell disease, a blood disorder that affects red blood cells. The study compares the effects of senicapoc to a placebo, which looks like the medicine but doesn't contain the active ingredient. Participants will continue taking hydroxyurea, a standard treatment for sickle cell disease, along with senicapoc or placebo for up to 24 weeks.

**Key Points**

  • The study lasts for 24 weeks.
  • Participants may need to visit a medical facility once a year for a sickle cell crisis.
  • Participants must be aged 16-35 years and currently using hydroxyurea.

Eligibility includes having sickle cell disease, being 16-35 years old, having certain blood levels (Hb ≤ 9.0 g/dL), and a history of no more than one severe crisis per year in the last two years. If you have been in a study with senicapoc before, have certain health conditions, or are part of a blood transfusion program, you cannot join this study. This study aims to help manage sickle cell disease by hopefully reducing symptoms and improving quality of life.

Study details
    Sickle Cell Disease
    Sickle Cell Anaemia
    Sickle Cell Anemia

NCT07282210

Biossil Inc.

12 September 2026

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