A PHASE 2/3 RANDOMIZED, MULTICENTER STUDY OF OSIVELOTOR ADMINISTERED ORALLY TO ADULT AND ADOLESCENT PARTICIPANTS WITH SICKLE CELL DISEASE
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.
This is a three-part, multicenter, Phase 2/3 study of orally administered osivelotor in participants with sickle cell disease (SCD).
Part A will evaluate the safety, tolerability, and efficacy of osivelotor in adult participants with SCD to determine an optimal dose. (Complete) Part B will evaluate the efficacy of osivelotor versus placebo in adult and adolescent participants with SCD for 48 weeks.
Open Label Extension (OLE) will evaluate the long-term safety and hematologic responses of open-label osivelotor in adult and adolescent participants having completed Part B.
Inclusion Criteria:
Part A and Part B:
Part B:
OLE:
- Participants who have completed the Part B successfully will be eligible.
Exclusion Criteria:
Part A and Part B:
OLE:
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
West Palm Beach, Florida 33407, United States
Chicago, Illinois 60612, United States
Chicago, Illinois 60612, United States
Chicago, Illinois 60612, United States
Baton Rouge, Louisiana 70805, United States
Baton Rouge, Louisiana 70808, United States
New Orleans, Louisiana 70112, United States
Southfield, Michigan 48075, United States
Madison, Mississippi 39110, United States
Chapel Hill, North Carolina 27514, United States
Chapel Hill, North Carolina 27517, United States
Greenville, South Carolina 29605, United States
Travelers Rest, South Carolina 29690, United States
Houston, Texas 77030, United States
Houston, Texas 77030, United States
Houston, Texas 77030, United States
Ribeirão Preto, São Paulo 14051-140, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
São Paulo, São Paulo 01321 001, Brazil
São Paulo, São Paulo 01323-900, Brazil
São, São Paulo 01228-000, Brazil
São Paulo, SÃO Paulo- Brasil 01232-011, Brazil
Rio de Janeiro, 20211-030, Brazil
São Paulo, 05403-000, Brazil
São Paulo, 05403-010, Brazil
Nashik, Maharashtra 422005, India
Kisumu, Siaya County 40600, Kenya
Nairobi, 00100, Kenya
Nairobi, 00200, Kenya
Bristol, BS2 8ED, United Kingdom
London, W12 0HS, United Kingdom