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New treatment option for Sickle Cell Disease
Official title A Phase 2/3 Study in Adult and Adolescent Participants With SCD
ClinicalTrials.gov ID: NCT05431088
What this study is testing
What is Osivelotor?
Osivelotor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for sickle cell disease.
Also referred to as PF-07940367 or GBT021601.
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
- The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
- 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
- Part A, Part B, and OLE:
- Male or female with SCD
- Participants with stable Hb value as judged 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...
- Participants with SCD ages 12 to 65 years, inclusive
You likely can't join if
- Part A, Part B, and OLE:
- 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...
See the full eligibility criteria
- Part A, Part B, and OLE:
- Male or female with SCD
- Participants with stable Hb value as judged 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...
- Participants with SCD ages 12 to 65 years, inclusive
- Participants with more than or equal to 2 and ≤ 10 VOCs within 12 months of Screening. OLE: \- Participants who have completed the Part B will be eligible.
- Part A, Part B, and OLE:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Plantation, Florida, United States
- West Palm Beach, Florida, United States
- Dunwoody, Georgia, United States
- Riverdale, Georgia, United States
- Chicago, Illinois, United States
- Baton Rouge, Louisiana, United States
- New Orleans, Louisiana, United States
- Madison, Mississippi, United States
- Kansas City, Missouri, United States
- Chapel Hill, North Carolina, United States
- Morrisville, North Carolina, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Salvador, Estado de Bahia, Brazil
- Recife, Pernambuco, Brazil
- Ribeirão Preto, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, SÃO Paulo- Brasil, Brazil
+ 10 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 - 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?
Study sites include New Haven, Connecticut, United States; Plantation, Florida, United States; West Palm Beach, Florida, United States; Dunwoody, Georgia, United States; Riverdale, Georgia, United States; Chicago, Illinois, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.