NCT07282210

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of SIL-8301 in Sickle Cell Disease (SCD) Patients With a Predominantly Hemolytic Phenotype

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Biossil Inc. · Industry
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease
• Sickle Cell Anaemia
• Sickle Cell Anemia

Interventions

Type	Name	Description
DRUG	Senicapoc	10 mg tablets; administered at a loading dose of 20 mg twice daily for 4 days, followed by a maintenance dose of 10 mg once daily for up to 24 weeks
DRUG	Placebo	Tablets similar in size and color; matching administration schedule

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-11-01
• Completion: 2029-01-01
• First posted: 2025-12-15
• Last updated: 2025-12-15