Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
Recruiting now Phase 2 NCT07282210
Run by Biossil Inc. · for 16 to 35 · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- Documented diagnosis of sickle cell disease
- 16-35 years of age
- Hb ≤ 9.0 g/dL
- History of no more than 1 acute SCD-related painful crises requiring a visit to a medical facility per year within the preceding 2 years
- History of at least one hemolytic complication
- Current treatment with hydroxyurea
🚫 You may not be able to join if…
- Receipt of senicapoc in a previous investigational study
- Current Red Blood Cell (RBC) transfusion or exchange transfusion program
- History of pulmonary hypertension
- Active cardiovascular, neurologic, endocrine, hepatic, or renal disorders
- Diagnosis of cancer (except non-melanoma skin cancer in situ, cervical cancer in situ, or breast cancer in situ) within the last 5 years
- History of liver disease
Where this trial is running
- The Hospital for Sick Children, Toronto, Ontario, Canada
- University Health Network, Toronto General Hospital, Toronto, Ontario, Canada
- Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada
- McGill University Health Centre, Montreal, Quebec, Canada
Who to contact
Head of Clinical Operations · (978) 245-7397 · trials@biossil.ai
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07282210.
Verify everything on the official ClinicalTrials.gov record. Page updated September 2026.