A Phase 2/3 Study of Osivelotor in Adult and Adolescent Participants With SCD
ConditionSickle Cell Disease
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorPfizer
About this trial
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Eligibility criteria
Qualifiers
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.
Participants with SCD ages 12 years and older, inclusive at screening.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Osivelotor
Treatment groups
389 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov