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RESCUENCT07282210

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 10 months later across 2 updates, enrollment reduced 38%.

See at-risk trials from Biossil Inc.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 105 → 65 participants Show 6 more changesShow less
    • Primary completion pushed from Jan 2029 to Oct 2029
    • Start date: Aug 13, 2026 to Nov 2026
    • Study completion pushed from Feb 2029 to Oct 2031
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 13 to 11
    • Site details revised at 3 of 4 sites
  2. Recruitment openedv2 Show 5 more changesShow less
    • Start date: Jan 2026 to Aug 13, 2026
    • Primary completion pushed from Nov 2028 to Jan 2029
    • Trial sites expanded: 0 → 4 locations
    • Study completion date: Jan 2029 to Feb 2029
    • Secondary endpoints: 10 to 13
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Hb response rate
Timeframe: 24 Weeks

Secondary (11)

Change from baseline in Hb (g/dL)
Change from baseline in lactate dehydrogenase (LDH) (u/L)
Change from baseline in indirect bilirubin (µmol/L)
Change from baseline in reticulocyte count (%)
Proportion of participants with a Hb increase of > 2g/dL from baseline
Show 6 moreShow less
Percent change from baseline in urine albumin-creatinine ratio (uACR)
Change from baseline in overall score and subscale domain scores of the Participant-Reported Outcomes Measurement Information System (PROMIS)
Sickle cell disease complication rate
Proportion of participants with at least one category of improvement from baseline in Clinician and Patient Global Impression of Change
Frequency of acute sickle cell-related painful crises
Incidence of AEs, SAEs, and sickle cell disease related AEs

Arms and interventions

Senicapoc (SIL-8301)Experimental

20 mg twice daily for 4 days, followed by 10 mg once daily for up to 24 weeks

PlaceboPlacebo comparator

Matching placebo tablets twice daily for 4 days, followed by once daily for up to 24 weeks

Drugs: Senicapoc, Placebo

Sites

4 sites in 1 country