A Phase 2/3 Study in Adult and Adolescent Participants With SCD
Recruiting now · Phase 2/Phase 3
Conditions studied: Sickle Cell Disease
In brief
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Key facts
- Study ID
- NCT05431088
- Run by
- Pfizer
- People needed
- 389
- Starts
- 2022-09-22
- Expected to finish
- 2032-12-31
- Last updated by the study team
- 2026-03-20
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Part A, Part B, and OLE:
- Male or female with SCD
- Participants with stable Hb value as judged 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 to 65 years, inclusive
- Participants with more than or equal to 2 and ≤ 10 VOCs within 12 months of Screening.
- OLE:
- Participants who have completed the Part B will be eligible.
You may not qualify if…
- Part A, Part B, and OLE:
- Participants who had more than 10 VOC within 12 months of screening
- Female participant who is breastfeeding or pregnant
- Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1
- Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF or anytime during the screening period.
Where it is running
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (enrolling)
- Edward Jenner Research Group Center LLC — Plantation, Florida, United States (enrolling)
- St. Mary's Medical Center — West Palm Beach, Florida, United States
- Alpha Clinical Research Georgia — Dunwoody, Georgia, United States
- Sonar Clinical Research — Riverdale, Georgia, United States
- University of Illinois at Chicago Clinical Research Center — Chicago, Illinois, United States
- University of Illinois Hospital and Health Sciences System - Investigational Drug Services (IDS) — Chicago, Illinois, United States
- University of Illinois Hospital and Health Sciences System — Chicago, Illinois, United States
- LSU Health Baton Rouge-North Clinic — Baton Rouge, Louisiana, United States
- Our Lady of the Lake Hospital, Inc. — Baton Rouge, Louisiana, United States
- Our lady of the Lake Hospital — Baton Rouge, Louisiana, United States
- University Medical Center New Orleans — New Orleans, Louisiana, United States
- Mississippi Center for Advanced Medicine — Madison, Mississippi, United States
- University Health — Kansas City, Missouri, United States
- Clinical & Translational Research Center (CTRC) — Chapel Hill, North Carolina, United States
- UNC Health — Chapel Hill, North Carolina, United States
- UNC Eastowne Medical Office Building - Consent Only — Chapel Hill, North Carolina, United States
- UNC IDS — Morrisville, North Carolina, United States
- McGovern Medical School at UTHealth — Houston, Texas, United States
- Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU) — Houston, Texas, United States
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
- UT Physicians Comprehensive Sickle Cell Clinic — Houston, Texas, United States
- Hospital Universitario Professor Edgar Santos — Salvador, Estado de Bahia, Brazil
- Multihemo Servicos Medicos S/A — Recife, Pernambuco, Brazil
- Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP — Ribeirão Preto, São Paulo, Brazil
Full record on ClinicalTrials.gov
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