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

RecruitingPhase 2, Phase 3

Sponsor: Pfizer

Conditions: Sickle Cell Disease

Interventions: Osivelotor

Countries: United States, Brazil, India, Kenya, Nigeria, Saudi Arabia, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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 Criteria:

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 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.
* Participants in Sub-Saharan Africa or who have relocated from Sub-Saharan Africa within 6 months.

OLE:

* 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.
* Met permanent treatment discontinuation criteria during Part B.
* Have withdrawn consent or are unable to comply with study procedure

Locations (80)

Mobile, Alabama, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Plantation, Florida, United States
West Palm Beach, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Dunwoody, Georgia, United States
Riverdale, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baton Rouge, Louisiana, United States
Baton Rouge, Louisiana, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Southfield, Michigan, United States
Flowood, Mississippi, United States
Madison, Mississippi, United States
Kansas City, Missouri, United States
New Brunswick, New Jersey, United States
New Brunswick, New Jersey, United States
New Brunswick, New Jersey, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Chapel Hill, North Carolina, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
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