A Phase 2/3 Study of Osivelotor in Adult and Adolescent Participants With SCD
Recruiting · NCT05431088 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
Osivelotor
What this trial is about
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Who can take part
Age range
12 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
- LE:
- \- 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.
- LE:
- 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- Have withdrawn consent or are unable to comply with study procedure
Where it is running
60 locations listed across 15 US states.
- AMR Clinical - Mobile, Alabama, United States
- Connecticut Children's Medical Center - Hartford, Connecticut, United States
- Smilow Cancer Hospital - New Haven, Connecticut, United States
- Edward Jenner Research Group LLC. - Plantation, Florida, United States
- Pediatric Hematology / Oncology a division of Kidz Medical services - West Palm Beach, Florida, United States
- St. Mary's Medical Center - West Palm Beach, Florida, United States
- Children's Center for Advanced Pediatrics - Atlanta, Georgia, United States
- Alpha Clinical Research Georgia - Dunwoody, Georgia, United States
- Sonar Clinical Research - Riverdale, Georgia, United States
- University of Illinois at Chicago Clinical Research Center - Chicago, Illinois, United States
- University of Illinois Hospital and Health Sciences System - Investigational Drug Services (IDS) - Chicago, Illinois, United States
- University of Illinois Hospital and Health Sciences System - Chicago, Illinois, United States
- LSU Health Baton Rouge-North Clinic - Baton Rouge, Louisiana, United States
- Our Lady of the Lake Hospital, Inc. - Baton Rouge, Louisiana, United States
- Our lady of the Lake Hospital - Baton Rouge, Louisiana, United States
- University Medical Center New Orleans - New Orleans, Louisiana, United States
- Children's Hospital of Michigan - Detroit, Michigan, United States
- Great Lakes Research Institute, Flourish Detroit - Southfield, Michigan, United States
- Southern Specialty Research - Flowood, Mississippi, United States
- Mississippi Center for Advanced Medicine - Madison, Mississippi, United States
- University Health - Kansas City, Missouri, United States
- Jack & Sheryl Morris Cancer Center - New Brunswick, New Jersey, United States
- Robert Wood Johnson University Hospital - New Brunswick, New Jersey, United States
- Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Jacobi Medical Center - The Bronx, New York, United States
- Clinical & Translational Research Center (CTRC) - Chapel Hill, North Carolina, United States
- UNC Health - Chapel Hill, North Carolina, United States
- UNC Eastowne Medical Office Building - Consent Only - Chapel Hill, North Carolina, United States
- Duke University IDS Pharmacy - Durham, North Carolina, United States
- Duke University Medical Center - Durham, North Carolina, United States
- ECU Physicians, Brody Outpatient Clinic - Greenville, North Carolina, United States
- UNC IDS - Morrisville, North Carolina, United States
- Prisma Health Laurens County Hospital - Clinton, South Carolina, United States
- Prisma Health - Upstate - Greenville, South Carolina, United States
- Prisma Health Greenville Memorial Hospital - Greenville, South Carolina, United States
- Prisma Health Outpatient Radiology - Greenville - Greenville, South Carolina, United States
- Prisma Health Patewood Hospital - Greenville, South Carolina, United States
- Prisma Health Greer Memorial Hospital - Greer, South Carolina, United States
- Prisma Health Hillcrest Hospital - Simpsonville, South Carolina, United States
- Prisma Health North Greenville Hospital - Travelers Rest, South Carolina, United States
- McGovern Medical School at UTHealth - Houston, Texas, United States
- Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU) - Houston, Texas, United States
- The University of Texas Health Science Center at Houston - Houston, Texas, United States
- UT Physicians Comprehensive Sickle Cell Clinic - Houston, Texas, United States
- Inova Schar Cancer Institute - Fairfax, Virginia, United States
- University Hospitals Bristol and Weston NHS Foundation Trust - Bristol, United Kingdom
- Bristol Royal Infirmary - Bristol, United Kingdom
- Aminu Kano Teaching Hospital - Kano, Nigeria
- Lagos University Teaching Hospital - Lagos, Nigeria
- University College London Hospital - London, United Kingdom
- Guy's & St Thomas' NHS Foundation Trust - London, United Kingdom
- King's College Hospital NHS Foundation Trust - London, United Kingdom
- Hammersmith Hospital, Imperial College Healthcare NHS Trust - London, United Kingdom
- Hammersmith Hospital - London, United Kingdom
- Gertrude's Children's Hospital - Nairobi, Kenya
- Kenya Medical Research Institute - Centre for Respiratory Disease Research - Nairobi, Kenya
- Center for Research In Therapeutic Sciences (CREATES), Strathmore University Medical Centre - Nairobi, Kenya
- Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO - Rio de Janeiro, Brazil
- Esho Empresa de Servicos Hospitalares S A - São Paulo, Brazil
Showing 60 of 80 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →