Sickle Cell Disease study: Osivelotor
Official title A Phase 2/3 Study of Osivelotor in Adult and Adolescent Participants With SCD
ClinicalTrials.gov ID: NCT05431088
What this study is testing
What is Osivelotor?
Osivelotor is an investigational oral tablet being studied as a potential treatment for sickle cell disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether osivelotor is safe, how well it works, and how it behaves in the body for people with sickle cell disease.
- Who it's for
- You may be able to join if you are an adult or teen with sickle cell disease.
- What's involved
- You will receive osivelotor and have blood tests and check‑ins to see how it affects you.
- Time commitment
- The study lasts several months and includes regular visits for tests and follow‑ups.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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.
- 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.
You likely can't join if
- 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...
- Have any unresolved clinically significant adverse event, laboratory abnormality, or safety finding from Part B that, in the opinion of the...
- Met permanent treatment discontinuation criteria during Part B.
See the full eligibility criteria
- 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.
- 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.
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Plantation, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Flowood, Mississippi, United States
- Kansas City, Missouri, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Greenville, North Carolina, United States
- Clinton, South Carolina, United States
- Greenville, South Carolina, United States
- Greer, South Carolina, United States
- Simpsonville, South Carolina, United States
- Travelers Rest, South Carolina, United States
- Fairfax, Virginia, United States
- São José do Rio Preto, São Paulo, Brazil
- Surat, Gujarat, India
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mobile, Alabama, United States; Plantation, Florida, United States; West Palm Beach, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Flowood, Mississippi, United States and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.