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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Osivelotor (drug)
How long the study runs: Study runs about 123 months (dates as stated)
About the drug or intervention: Osivelotor — drug: Tablets which contain drug substance
Patient visit burden: Not specified by the sponsor

In plain English

This is a Phase 2/3 study looking at a medicine called osivelotor in adults and teenagers with sickle cell disease. It has different parts: Part A, Part B, and an open-label extension (OLE) for people who finish Part B. It is funded by Pfizer.

Who can take part

Males or females with sickle cell disease of the types HbSS or HbSB-zero
A haemoglobin level between 5.5 and 10.5 g/dL at screening, and considered stable by the study doctor
If taking hydroxyurea and/or L-glutamine, the dose must have been stable for at least 90 days before joining, with no expected need to change it during the study
For Part B: aged 12 or older at screening
For Part B: between 2 and 10 vaso-occlusive crises (VOCs, painful sickle cell episodes) in the 12 months before screening
For the open-label extension: people who have successfully completed Part B

Who may not be able to

More than 10 VOCs (painful sickle cell episodes) in the 12 months before screening
People who are pregnant or breastfeeding
Regular red blood cell transfusions, or any red blood cell transfusion within 90 days of Day 1
Being in hospital for a sickle cell crisis or other blockage episode within 14 days of joining, or any time during screening
Living in Sub-Saharan Africa or having moved from there within the past 6 months
For the open-label extension: any ongoing significant side effect, abnormal test result, or safety finding from Part B that the study doctor thinks makes the study drug riskier; meeting the rules for stopping treatment during Part B; having withdrawn consent; or being unable to follow the study procedures

What taking part involves

• The study medicine is called osivelotor — Not stated — ask the trial team for full details of what treatment involves.

Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 12 Years and over
Who: All
Number of participants: 389
Started: 2022-09-22
Last checked: 2026-08

Plain English Summary

What is this study?

• Testing a new treatment for sickle cell disease
• Phase2/Phase3 - 389 participants
• The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor

Who can take part?

• Ages 12 Years and over
• Diagnosed with sickle cell disease

Where?

• Bristol - University Hospitals Bristol and Weston NHS Foundation Trust
• Bristol - Bristol Royal Infirmary
• London - University College London Hospital
• London - Guy's & St Thomas' NHS Foundation Trust
• +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Sickle Cell Disease

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 12 Years and over
Who can join: All genders

Biomarkers mentioned

Met

What the study is looking for

✓Part A and Part B:
✓Male or female with SCD, HbSS and HbSB-zero
✓Participants with red blood cell level ≥ 5.5 and ≤ 10.5 g/dL during Screening and considered stable by the Investigator.
✓Part B:
✓Participants with SCD ages 12 years and older, inclusive at screening.

Who cannot take part

✗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...
✗Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF or...

See the 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