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

Sickle Cell Disease Clinical Trial

Official title:
A Phase 2/3 Randomized, Multicenter Study of Osivelotor Administered Orally to Participants With Sickle Cell Disease and an Open-Label Pharmacokinetics Study in Pediatric Participants With Sickle Cell Disease

Clinical Trial Summary

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

Clinical Trial Description

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. Part B will evaluate the efficacy of osivelotor versus placebo in adult and adolescent participants with SCD for 48 weeks. Part C will evaluate the pharmacokinetics (PK) and safety of single and multiple doses (MD) of open-label single arm osivelotor administered to pediatric participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05431088
Study type Interventional
Source Pfizer
Contact Pfizer Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Status Recruiting
Phase Phase 2/Phase 3
Start date September 22, 2022
Completion date October 2, 2026
View Details
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