A Phase 2/3 Study in Adult and Adolescent Participants With SCD

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT05431088
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Osivelotor — DRUG
    Tablets which contain drug substance

Study Details

The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.

Key Dates

Start date
Sep 22, 2022
Status verified
Mar 2026
Primary completion
Dec 30, 2030
Completion
Dec 31, 2032

Study Design

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

Arms

  • Active Comparator: Part A
    Initially, participants will be randomized 1:1 to 100 mg and 150 mg daily. Upon review of the 150 mg safety data from at least 6 participants, there will be 1:1:1 randomization: 100 mg, 150 mg, and up to 200 mg. Participants will then receive maintenance once daily doses through Week 12.
  • Placebo Comparator: Part B
    Study drug arm: Adult participants will receive osivelotor at 300 mg QD loading dose for 7 days followed by 150 mg QD through Week 48. Adolescent participant dose will be defined in a future protocol amendment. Placebo arm: Participants will receive placebo tablets for 48 weeks.
  • Experimental: OLE
    Adult Participants will receive 150 mg open-label osivelotor up to 2 years after the last participant's visit in Part B or when the drug is commercially available in that region. The appropriate doses for adolescents will be defined in a future protocol amendment.

Primary Outcome Measure

Part A [ Time Frame: Through week 12 ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Smilow Cancer HospitalNew HavenConnecticut06511-
Edward Jenner Research Group Center LLCPlantationFlorida33317-
Pediatric Hematology / Oncology a division of Kidz Medical servicesWest Palm BeachFlorida33407-
St. Mary's Medical CenterWest Palm BeachFlorida33407-
Alpha Clinical Research GeorgiaDunwoodyGeorgia30350-
Sonar Clinical ResearchRiverdaleGeorgia30274-
University of Illinois at Chicago Clinical Research CenterChicagoIllinois60612-
University of Illinois Hospital and Health Sciences SystemChicagoIllinois60612-
University of Illinois Hospital and Health Sciences System - Investigational Drug Services (IDS)ChicagoIllinois60612-
LSU Health Baton Rouge-North ClinicBaton RougeLouisiana70805-
Our lady of the Lake HospitalBaton RougeLouisiana70808-
Our Lady of the Lake Hospital, Inc.Baton RougeLouisiana70808-
University Medical Center New OrleansNew OrleansLouisiana70112-
Mississippi Center for Advanced MedicineMadisonMississippi39110-
University HealthKansas CityMissouri64108-
Clinical & Translational Research Center (CTRC)Chapel HillNorth Carolina27514-
UNC Eastowne Medical Office Building - Consent OnlyChapel HillNorth Carolina27517-
UNC HealthChapel HillNorth Carolina27514-
UNC IDSMorrisvilleNorth Carolina27560-
McGovern Medical School at UTHealthHoustonTexas77030-
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)HoustonTexas77030-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
UT Physicians Comprehensive Sickle Cell ClinicHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in New Haven, CT

By condition
Sickle cell disease
By research site
Smilow Cancer Hospital· New Haven, CTEdward Jenner Research Group Center LLC· Plantation, FLPediatric Hematology / Oncology a division of Kidz Medical services· West Palm Beach, FLSt. Mary's Medical Center· West Palm Beach, FLAlpha Clinical Research Georgia· Dunwoody, GASonar Clinical Research· Riverdale, GA

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