Clinical Trial
Study Details
Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.
Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug
This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.
Study Overview
Eligible participants will be administered inclacumab or placebo intravenous (IV) every 12 weeks.
The total duration of treatment for each participant will be 48 weeks.
Participants that complete the study through Week 48 will be provided the opportunity to enroll in an open-label extension (OLE) study.
Contacts and Locations
University of South Alabama Children's and Women's Hospital
Mobile, Alabama 36604
United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama 36604
United States
University of South Alabama Strada Patient Care Center
Mobile, Alabama 36604
United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United States
UC Irvine Health
Orange, California 92868
United States
UCI Center for clinical research
Orange, California 92868
United States
Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell
Farmington, Connecticut 06030
United States
Hospital Pharmacy Services- Investigational Drug Services
Chicago, Illinois 60612
United States
Rush University Medical Center Investigator Pharmacy
Chicago, Illinois 60612
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
University of Illinois Clinical Research Center (CRC)
Chicago, Illinois 60612
United States
University of Illinois Hospital and Health Sciences System(UI Health)
Chicago, Illinois 60612
United States
Dana-Farber Cancer Institute IDS Pharmacy
Boston, Massachusetts 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan 48109
United States
Jacobi Medical Center
The Bronx, New York 10461
United States
Duke University Medical Center
Durham, North Carolina 27705
United States
DUMC Investigational Drug Services Pharmacy
Durham, North Carolina 27710
United States
McGovern Medical School/Health Science Center Houston
Houston, Texas 77030
United States
Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy
Houston, Texas 77030
United States
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
Houston, Texas 77030
United States
UT Physicians Comprehensive Sickle Cell Clinic
Houston, Texas 77030
United States
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador-Estado de Bahia
41253-190
Brazil
Multihemo Serviços Médicos S/A
Recife-Pernambuco
50070-460
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre-Rio Grande do Sul
90035-903
Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto-São Paulo
14051-140
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto-São Paulo
15090-000
Brazil
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
Rio de Janeiro
20211-030
Brazil
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
São Paulo
01232-010
Brazil
Casa de Saúde Santa Marcelina
São Paulo
08270-070
Brazil
CEPEC-Centro de Pesquisa Clinica
São Paulo
08270-120
Brazil
Clinica de la Costa Ltda.
Barranquilla, Atlántico, 080020
Colombia
Sociedad de Oncologia y hematologia del Cesar S.A.S.
Valledupar, Cesar Department, 200001
Colombia
Faculty of Medicine Cairo University
Cairo
11562
Egypt
AinShams University Hospital
Cairo
11588
Egypt
Hôpital Henri Mondor
94010 Créteil
France
Institut Universitaire du Cancer de Toulouse-Oncopole
31059 Toulouse
France
KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex
Kisumu
40600
Kenya
International Cancer Institute
Eldoret
30100
Kenya
Gertrude's Children Hospital
Nairobi
00100
Kenya
Kenya Medical Research Institute- Center for Respiratory Disease Research
Nairobi
00100
Kenya
Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)
Nairobi
00200
Kenya
American University of Beirut Medical Center
Hamra
Lebanon
Nini Hospital
Tripoli
Lebanon
University of Calabar Teaching Hospital
Calabar 540242
Cross River State
Nigeria
National Hospital Abuja
Abuja 900211
Federal Capital Territory
Nigeria
University of Abuja Teaching Hospital
Gwagwalada 902101
Federal Capital Territory
Nigeria
Ahmadu Bello University Teaching Hospital
Zaria 1100011
Kaduna State
Nigeria
University of Nigeria Teaching Hospital
Enugu 460000
Nigeria
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna 800212
Nigeria
Aminu Kano Teaching Hospital
Kano 700233
Nigeria
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
Lagos 100254
Nigeria
Sultan َQaboos University Hospital
123
Muscat
Oman
Prince Mohammed bin Nasser Hospital
Jizan 82943
Saudi Arabia
NIMR-Mbeya Medical Research Center
Mbeya
Tanzania