Recruiting
Phase 2

Senicapoc

Sponsor:

Biossil Inc.

Code:

NCT07282210

Conditions

Sickle Cell Disease

Sickle Cell Anaemia

Sickle Cell Anemia

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Interventions

Senicapoc

Placebo

Study Details

Brief 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

Study ID

NCT07282210

Start date

Aug 13, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Placebo

Tablets similar in size and color; matching administration schedule

Primary outcome measure

  • Hb response rate [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

Head of Clinical Operations

(978) 245-7397trials@biossil.ai

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Biossil Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • senicapoc
  • Anemia, Hemolytic, Congenital
  • Anemia, Hemolytic
  • Anemia
  • Hematologic Diseases
  • Hemic and Lymphatic Diseases
  • Hemoglobinopathies
  • Genetic Diseases, Inborn
  • Congenital, Hereditary, and Neonatal Diseases and Abnormalities
  • Anemia, Sickle Cell
  • Anaemia, Sickle Cell

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Biossil Inc. on 2026-08-17.