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RecruitingPhase 2/Phase 3

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

Pfizer · NCT05431088

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
389
US sites recruiting
27
Study start
September 22, 2022
Record last updated
August 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Osivelotor

Conditions: Sickle Cell Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Pfizer Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com
A Phase 2/3 Study of Osivelotor in Adult and Adolescent… (NCT05431088) | Bored Studies