Tests osivelotor, a pill, in people with sickle cell disease
Tests the oral drug osivelotor in teens and adults with sickle cell disease.
Plain-language title generated from the registry record
Registry title: A Phase 2/3 Study of Osivelotor in Adult and Adolescent Participants With SCD
Key facts
- Where
- Atlanta, Baton Rouge, Chapel Hill, Chicago, Clinton, Detroit, Dunwoody, Durham, Fairfax, Flowood, Greenville, Greer, Hartford, Houston, Kansas City, Madison, Mobile, Morrisville, New Brunswick, New Haven, New Orleans, New York, Plantation, Riverdale, Simpsonville, Southfield, The Bronx, Travelers Rest, and West Palm Beach, United StatesSee the 46 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 64 years old?
Source: NCT05431088, who can take part
Where in United States
- Children's Center for Advanced PediatricsAtlanta, United StatesTaking people
- LSU Health Baton Rouge-North ClinicBaton Rouge, United StatesNo longer taking part
- Our Lady of the Lake HospitalBaton Rouge, United StatesNo longer taking part
- Our Lady of the Lake Hospital, Inc.Baton Rouge, United StatesNo longer taking part
- Clinical & Translational Research Center (CTRC)Chapel Hill, United StatesNot yet recruiting
- UNC Eastowne Medical Office Building - Consent OnlyChapel Hill, United StatesNot yet recruiting
- UNC HealthChapel Hill, United StatesNot yet recruiting
- University of Illinois at Chicago Clinical Research CenterChicago, United StatesTaking people
- University of Illinois Hospital and Health Sciences SystemChicago, United StatesTaking people
- University of Illinois Hospital and Health Sciences System - Investigational Drug Services (IDS)Chicago, United StatesTaking people
- Prisma Health Laurens County HospitalClinton, United StatesTaking people
- Children's Hospital of MichiganDetroit, United StatesNot yet recruiting
- Alpha Clinical Research GeorgiaDunwoody, United StatesNo longer taking part
- Duke University IDS PharmacyDurham, United StatesTaking people
- Duke University Medical CenterDurham, United StatesTaking people
- Inova Schar Cancer InstituteFairfax, United StatesTaking people
- Southern Specialty ResearchFlowood, United StatesTaking people
- ECU Physicians, Brody Outpatient ClinicGreenville, United StatesTaking people
- Prisma Health Greenville Memorial HospitalGreenville, United StatesTaking people
- Prisma Health Outpatient Radiology - GreenvilleGreenville, United StatesTaking people
- Prisma Health Patewood HospitalGreenville, United StatesTaking people
- Prisma Health-UpstateGreenville, United StatesTaking people
- Prisma Health Greer Memorial HospitalGreer, United StatesTaking people
- Connecticut Children's Medical CenterHartford, United StatesNot yet recruiting
- McGovern Medical School at UTHealthHouston, United StatesNo longer taking part
- Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)Houston, United StatesNo longer taking part
- The University of Texas Health Science Center at HoustonHouston, United StatesNo longer taking part
- UT Physicians Comprehensive Sickle Cell ClinicHouston, United StatesNo longer taking part
- University HealthKansas City, United StatesTaking people
- Mississippi Center for Advanced MedicineMadison, United StatesNo longer taking part
- AMR ClinicalMobile, United StatesTaking people
- UNC IDSMorrisville, United StatesNot yet recruiting
- Jack & Sheryl Morris Cancer CenterNew Brunswick, United StatesTaking people
- Robert Wood Johnson University HospitalNew Brunswick, United StatesTaking people
- Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
- Smilow Cancer HospitalNew Haven, United StatesNot yet recruiting
- University Medical Center New OrleansNew Orleans, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Edward Jenner Research Group LLCPlantation, United StatesTaking people
- Sonar Clinical ResearchRiverdale, United StatesNo longer taking part
- Prisma Health Hillcrest HospitalSimpsonville, United StatesTaking people
- Great Lakes Research Institute, Flourish DetroitSouthfield, United StatesNot yet recruiting
- Jacobi Medical CenterThe Bronx, United StatesTaking people
- Prisma Health North Greenville HospitalTravelers Rest, United StatesTaking people
- Pediatric Hematology / Oncology a division of Kidz Medical servicesWest Palm Beach, United StatesTaking people
- St. Mary's Medical CenterWest Palm Beach, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05431088EU 2023-508766-14-00
- Record updated
- 18 August 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.Read full original descriptionShow less
A PHASE 2/3 RANDOMIZED, MULTICENTER STUDY OF OSIVELOTOR ADMINISTERED ORALLY TO ADULT AND ADOLESCENT PARTICIPANTS WITH SICKLE CELL DISEASE
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Inclusion: Part A and Part B:; Male or female with SCD, HbSS and HbSB-zero; Participants with Hemoglobin ≥ 5.5 and ≤ 10.5 g/dL during Screening and considered stable by the Investigator; For participants taking hydroxyurea and/or L-glutamine, the dose must be stable for at least 90 days prior to signing the ICF or assent and with no anticipated need for dose adjustments during the study in the opinion of the Investigator; Part B:; Participants with SCD ages 12 years and older, inclusive at screening; Participants with more than or equal to 2 and ≤ 10 VOCs within 12 months of Screening; OLE:; Participants who have completed the Part B successfully will be eligible.
Exclusion: Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1; Have any unresolved clinically significant adverse event, laboratory abnormality, or safety finding from Part B that, in the opinion of the Investigator, increases the risk of study drug administration; Part A and Part B:; Participants who had more than 10 VOC within 12 months of screening; Female participant who is breastfeeding or pregnant; Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF or anytime during the screening period; Participants in Sub-Saharan Africa or who have relocated from Sub-Saharan Africa within 6 months; OLE:; Met permanent treatment discontinuation criteria during Part B; Have withdrawn consent or are unable to comply with study procedure.