Tests osivelotor, a pill, in people with sickle cell disease
Tests the oral drug osivelotor in teens and adults with sickle cell disease.
Plain-language title generated from the registry record
Registry title: A Phase 2/3 Study of Osivelotor in Adult and Adolescent Participants With SCD
Key facts
- Where
- Bhubaneswar, Nashik, New Delhi, Raipur, Surat, and Vadodara, IndiaSee the 6 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 64 years old?
Source: NCT05431088, who can take part
Where in India
- AIIMS, BhubaneswarBhubaneswar, IndiaNot yet recruiting
- Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart InstituteNashik, IndiaTaking people
- AIIMS,DelhiNew Delhi, IndiaNot yet recruiting
- AIIMS RaipurRaipur, IndiaNot yet recruiting
- Nirmal Hospital Pvt Ltd.Surat, IndiaTaking people
- Haemato Oncology Care CentreVadodara, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05431088EU 2023-508766-14-00
- Record updated
- 18 August 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.Read full original descriptionShow less
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.
Inclusion: 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: Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1; 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; 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 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:; Met permanent treatment discontinuation criteria during Part B; Have withdrawn consent or are unable to comply with study procedure.