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

Sponsor
Biossil Inc.
Study ID
NCT07282210
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Senicapoc — DRUG
    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
  • Placebo — DRUG
    Tablets similar in size and color; matching administration schedule

Study Details

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.

Key Dates

First listed
Dec 15, 2025
Start date
Aug 13, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Senicapoc (SIL-8301)
    20 mg twice daily for 4 days, followed by 10 mg once daily for up to 24 weeks
  • Placebo Comparator: Placebo
    Matching placebo tablets twice daily for 4 days, followed by once daily for up to 24 weeks

Primary Outcome Measure

Hb response rate [ Time Frame: 24 Weeks ]

Central Contacts

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