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NCT07401823

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

Enrolling by Invitation
PHASE2Ages 18+InterventionalTreatment
Fulcrum Therapeutics
~50 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:Pociredir

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
Measured over Up to Week 196
+3 more outcomes measured

Conditions

Sickle Cell Disease

Explore related trials

Sickle Cell DiseaseHemoglobin F

Where it's being run

8 sites across 7 states
New York2
Arkansas1
California1
Louisiana1
Massachusetts1
Texas1
Virginia1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Participants aged ≥18 years and older must have previously participated in and successfully completed Study 6058-SCD-101.
Participant has signed and dated the informed consent form (ICF) before any study-specific procedures are performed and is willing and able to comply with the study procedures and restrictions.
Participants, who if female and of childbearing potential, agree to use 2 effective methods of contraception, 1 of which must be highly effective, or practice abstinence starting at the time of the ICF signing to 90 days after the last dose of study drug, and, who if male, should use condoms or practice abstinence from the time of ICF signing to 90 days after the last dose of study drug.
Documented HbF benefit, as judged by the Investigator, from prior study.
Participant must meet both of the following laboratory values during Screening:
Absolute reticulocyte count during Screening \> 100 × 10\^9/liter.

Exclusion

Major surgery, serious illness (acute or chronic), infection (clinically significant bacterial, fungal, parasitic or viral infection which requires therapy), fever not resolved within 3 days of onset and requiring treatment, significant bleeding, cerebrovascular accident, or seizure within 14 days prior to signing the ICF and 14 days prior to starting study drug.
Sickle cell complication requiring more than 24-hour care from a medical provider in hospital or emergency care setting in the 14 days prior to starting study drug.
Use of medications that are moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 or CYP2C8, inhibit P-glycoprotein, breast cancer resistance protein, or multidrug and toxin extrusion protein 2-K, or are substrates of CYP2B6 within 14 days prior to first dose of study drug or anticipated need for any of these medications during the study.
Participation in any other study with an investigational agent other than pociredir within the past 60 days prior to the first dose of study drug.
History of bone marrow transplant or hematopoietic stem cell transplant or gene therapies.
Vaccination in the previous 7 days prior to the first dose of study drug.

What this trial measures

  • Number of participants reporting Treatment Emergent Adverse Events (TEAEs)Up to Week 196
  • Number of participants with clinically significant changes in 12-lead Electrocardiogram (ECGs)Up to Week 196
  • Number of participants with clinically significant changes in Vital signsUp to Week 196
  • Number of participants with clinically significant changes in Clinical laboratory testsUp to Week 196

    Laboratory assessments including hematology, coagulation, serum chemistry and electrolytes, lipid panel, SCD characterization, serology, urinalysis and pregnancy tests will be performed.