A Phase 2/3 Randomized, Multicenter Study of Osivelotor Administered Orally to Adult and Adolescent Participants With Sickle Cell Disease
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
⁃ 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 of the Investigator.
⁃ Part B:
• 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.
Locations
United States
Connecticut
Smilow Cancer Hospital
NOT_YET_RECRUITING
New Haven
Florida
Edward Jenner Research Group Center LLC
RECRUITING
Plantation
Pediatric Hematology / Oncology a division of Kidz Medical services
NOT_YET_RECRUITING
West Palm Beach
St. Mary's Medical Center
NOT_YET_RECRUITING
West Palm Beach
Georgia
Alpha Clinical Research Georgia
ACTIVE_NOT_RECRUITING
Dunwoody
Sonar Clinical Research
ACTIVE_NOT_RECRUITING
Riverdale
Illinois
University of Illinois at Chicago Clinical Research Center
NOT_YET_RECRUITING
Chicago
University of Illinois Hospital and Health Sciences System
NOT_YET_RECRUITING
Chicago
University of Illinois Hospital and Health Sciences System - Investigational Drug Services (IDS)
NOT_YET_RECRUITING
Chicago
Louisiana
LSU Health Baton Rouge-North Clinic
ACTIVE_NOT_RECRUITING
Baton Rouge
Our lady of the Lake Hospital
ACTIVE_NOT_RECRUITING
Baton Rouge
Our Lady of the Lake Hospital, Inc.
ACTIVE_NOT_RECRUITING
Baton Rouge
University Medical Center New Orleans
ACTIVE_NOT_RECRUITING
New Orleans
Missouri
University Health
NOT_YET_RECRUITING
Kansas City
Mississippi
Mississippi Center for Advanced Medicine
ACTIVE_NOT_RECRUITING
Madison
North Carolina
Clinical & Translational Research Center (CTRC)
NOT_YET_RECRUITING
Chapel Hill
UNC Eastowne Medical Office Building - Consent Only
NOT_YET_RECRUITING
Chapel Hill
UNC Health
NOT_YET_RECRUITING
Chapel Hill
UNC IDS
NOT_YET_RECRUITING
Morrisville
Texas
McGovern Medical School at UTHealth
ACTIVE_NOT_RECRUITING
Houston
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
ACTIVE_NOT_RECRUITING
Houston
The University of Texas Health Science Center at Houston
ACTIVE_NOT_RECRUITING
Houston
UT Physicians Comprehensive Sickle Cell Clinic
ACTIVE_NOT_RECRUITING
Houston
Virginia
Inova Schar Cancer Institute
RECRUITING
Fairfax
Other Locations
Brazil
Multihemo Servicos Medicos S/A
NOT_YET_RECRUITING
Recife
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
NOT_YET_RECRUITING
Ribeirão Preto
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
NOT_YET_RECRUITING
Rio De Janeiro
Hospital Universitario Professor Edgar Santos
NOT_YET_RECRUITING
Salvador
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
NOT_YET_RECRUITING
São José Do Rio Preto
BP - A Beneficência Portuguesa de São Paulo
NOT_YET_RECRUITING
São Paulo
BP A Beneficência Portuguesa de São Paulo
NOT_YET_RECRUITING
São Paulo
Casa de Saude Santa Marcelina
NOT_YET_RECRUITING
São Paulo
Casa de Saude Santa Marcelina
NOT_YET_RECRUITING
São Paulo
Esho Empresa de Servicos Hospitalares S A
NOT_YET_RECRUITING
São Paulo
Esho Empresa de Servicos Hospitalares S A
NOT_YET_RECRUITING
São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
ACTIVE_NOT_RECRUITING
São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
ACTIVE_NOT_RECRUITING
São Paulo
Real e Benemerita Associacao Portuguesa de Sao Paulo
NOT_YET_RECRUITING
São Paulo
India
Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute
ACTIVE_NOT_RECRUITING
Nashik
Nirmal Hospital Pvt Ltd
ACTIVE_NOT_RECRUITING
Surat
Kenya
KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex
NOT_YET_RECRUITING
Kisumu
Center for Research In Therapeutic Sciences (CREATES), Strathmore University Medical Centre
NOT_YET_RECRUITING
Nairobi
Gertrude's Children's Hospital
NOT_YET_RECRUITING
Nairobi
Kenya Medical Research Institute - Centre for Respiratory Disease Research
NOT_YET_RECRUITING
Nairobi
Nigeria
University College Hospital Ibadan
ACTIVE_NOT_RECRUITING
Ibadan
Aminu Kano Teaching Hospital
ACTIVE_NOT_RECRUITING
Kano
Lagos University Teaching Hospital
ACTIVE_NOT_RECRUITING
Lagos
United Kingdom
Bristol Royal Infirmary
NOT_YET_RECRUITING
Bristol
University Hospitals Bristol and Weston NHS Foundation Trust
NOT_YET_RECRUITING
Bristol
Contact Information
Primary
Pfizer Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-09-22
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 389
Treatments
Active_comparator: Part A
Initially, participants will be randomized 1:1 to 100 mg and 150 mg daily. Upon review of the 150 mg safety data from at least 6 participants, there will be 1:1:1 randomization: 100 mg, 150 mg, and up to 200 mg.~Participants will then receive maintenance once daily doses through Week 12.
Placebo_comparator: Part B
Study drug arm: Adult participants will receive osivelotor at 300 mg QD loading dose for 7 days followed by 150 mg QD through Week 48.~Adolescent participant dose will be defined in a future protocol amendment.~Placebo arm: Participants will receive placebo tablets for 48 weeks.
Experimental: OLE
Adult Participants will receive 150 mg open-label osivelotor up to 2 years after the last participant's visit in Part B or when the drug is commercially available in that region.~The appropriate doses for adolescents will be defined in a future protocol amendment.
Related Therapeutic Areas
Sponsors
Leads: Pfizer