A Phase 2/3 Study in Adult and Adolescent Participants With SCD
Start Date
9/22/2022
Completion Date
12/31/2032
Summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Detailed Description
This is a three-part, multicenter, Phase 2/3 study of orally administered osivelotor in participants with sickle cell disease (SCD). Part A will evaluate the safety, tolerability, and efficacy of osivelotor in adult participants with SCD to determine an optimal dose. Part B will evaluate the efficacy of osivelotor versus placebo in adult and adolescent participants with SCD for 48 weeks. Open Label Extension (OLE) will evaluate the long-term safety and hematologic responses of open-label osivelotor in adult and adolescent participants having completed Part B.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
Osivelotor
Conditions
Locations
Smilow Cancer Hospital
New Haven, Connecticut 06511
United States
Edward Jenner Research Group Center LLC
Plantation, Florida 33317
United States
Pediatric Hematology / Oncology a division of Kidz Medical services
West Palm Beach, Florida 33407
United States
St. Mary's Medical Center
West Palm Beach, Florida 33407
United States
Alpha Clinical Research Georgia
Dunwoody, Georgia 30350
United States
Sonar Clinical Research
Riverdale, Georgia 30274
United States
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois 60612
United States
University of Illinois Hospital and Health Sciences System - Investigational Drug Services (IDS)
Chicago, Illinois 60612
United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois 60612
United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
United States
Our Lady of the Lake Hospital, Inc.
Baton Rouge, Louisiana 70808
United States
Our lady of the Lake Hospital
Baton Rouge, Louisiana 70808
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Mississippi Center for Advanced Medicine
Madison, Mississippi 39110
United States
University Health
Kansas City, Missouri 64108
United States
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina 27514
United States
UNC Health
Chapel Hill, North Carolina 27514
United States
UNC Eastowne Medical Office Building - Consent Only
Chapel Hill, North Carolina 27517
United States
UNC IDS
Morrisville, North Carolina 27560
United States
McGovern Medical School at UTHealth
Houston, Texas 77030
United States
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
Houston, Texas 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
UT Physicians Comprehensive Sickle Cell Clinic
Houston, Texas 77030
United States
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United States
Hospital Universitario Professor Edgar Santos
Salvador, Estado de Bahia 40110-060
Brazil
Multihemo Servicos Medicos S/A
Recife, Pernambuco 50070-460
Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo 14051-140
Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo 15090-000
Brazil
BP A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo 01321 001
Brazil
BP - A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo 01323-900
Brazil
Casa de Saude Santa Marcelina
São Paulo, São Paulo 08270-070
Brazil
Casa de Saude Santa Marcelina
São Paulo, São Paulo 08270-120
Brazil
Esho Empresa de Servicos Hospitalares S A
São Paulo, SÃO Paulo- Brasil 01232-011
Brazil
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, 20211-030
Brazil
Esho Empresa de Servicos Hospitalares S A
São Paulo, 01232-010
Brazil
Real e Benemerita Associacao Portuguesa de Sao Paulo
São Paulo, 01321-001
Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403-000
Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403-010
Brazil
Nirmal Hospital Pvt Ltd
Surat, Gujarat 395002
India
Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute
Nashik, Maharashtra 422005
India
KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex
Kisumu, Siaya County 40600
Kenya
Gertrude's Children's Hospital
Nairobi, 00100
Kenya
Kenya Medical Research Institute - Centre for Respiratory Disease Research
Nairobi, 00100
Kenya
Center for Research In Therapeutic Sciences (CREATES), Strathmore University Medical Centre
Nairobi, 00200
Kenya
University College Hospital Ibadan
Ibadan, Oyo/ibadan North 200212
Nigeria
Aminu Kano Teaching Hospital
Kano, 700233
Nigeria
Lagos University Teaching Hospital
Lagos, 100254
Nigeria
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS2 8ED
United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8EX
United Kingdom