Open-Label Extension Study to Pioneer Study 6058-SCD-101

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Fulcrum Therapeutics
Study ID
NCT07401823
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pociredir — DRUG
    Pociredir Oral Capsules will be administered

Study Details

This is an open-label study to evaluate the safety and tolerability of long-term treatment with pociredir without a comparator in participants with SCD who have previously been treated and shown benefit with pociredir in feeder study 6058-SCD-101 (NCT05169580). Participants in this study will receive once daily doses of pociredir for up to 48 months.

Key Dates

Start date
Mar 30, 2026
Status verified
Apr 2026
Primary completion
Feb 4, 2030
Completion
Jul 5, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pociredir
    Participants will receive Pociredir orally once daily (QD)

Primary Outcome Measure

Number of participants reporting Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 196 ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
University of California, Los AngelesLos AngelesCalifornia90095-
Our Lady of the Lake HospitalBaton RougeLouisiana70808-
Boston Medical CenterBostonMassachusetts02118-
Queens Hospital Cancer CenterJamaicaNew York11432-
Jacobi Medical CenterThe BronxNew York10461-
University of Texas HoustonHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Little Rock, AR

By condition
Sickle cell disease
By research site
University of Arkansas for Medical Sciences· Little Rock, ARUniversity of California, Los Angeles· Los Angeles, CAOur Lady of the Lake Hospital· Baton Rouge, LABoston Medical Center· Boston, MAQueens Hospital Cancer Center· Jamaica, NYJacobi Medical Center· The Bronx, NY

Related Studies