A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

PHASE3CompletedINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

October 4, 2021

Primary Completion Date

June 6, 2024

Study Completion Date

June 6, 2024

Conditions
Sickle Cell DiseaseVaso-occlusive Pain Episode in Sickle Cell DiseaseVaso-occlusive Crisis
Interventions
DRUG

Inclacumab

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.

DRUG

Placebo

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

Trial Locations (98)

123

Sultan َQaboos University Hospital, Muscat

10101

Arthur Davison Childrens's Hospital, Ndola

Matero Clinical Research Site,, Lusaka

University Teaching Hospital- Children's Hospital, Lusaka

10461

Jacobi Medical Center, The Bronx

11562

Al Kasr Al Ainy Cairo University Hospital, Elmanial

Faculty of Medicine Cairo University, Cairo

11588

AinShams University Hospital, Cairo

11617

Cairo University Paediatric Hospital - abou el Reesh University Hospital, El-Rashidy Street, ElSayeda Zeinb

14215

Erie County Medical Center, Buffalo

16128

Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera, Genova

S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro Azienda, Genova

27705

Duke University Medical Center, Durham

27710

DUMC Investigational Drug Services Pharmacy, Durham

30100

International Cancer Institute, Eldoret

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

30342

Children's Healthcare of Atlanta - Scottish Rite, Atlanta

Children's Healthcare of Atlanta, Atlanta

31059

Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse

33343

Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi, Yenişehir

33606

University of South Florida, Tampa

USF Health South Tampa Center for Advanced Healthcare, Tampa

33612

John S. Curran, MD.,Children's Health Center, Tampa

USF Clinical Investigational Research Pharmacy, Tampa

USF Health Carol & Frank Morsani Center for Advanced Healthcare, Tampa

35128

Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica, Padua

Farmacia Azienda Ospedale Universita Padova, Padua

U.O.C. Farmacia Istituto Oncologico Veneto, Padua

36604

University of South Alabama Children's and Women's Hospital, Mobile

University of South Alabama Mitchell Cancer Institute, Mobile

University of South Alabama Strada Patient Care Center, Mobile

38105

St. Jude Children's Research Hospital, Memphis

40600

KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex, Kisumu

44519

Zagazig University Hospital, Zagazig

48109

University of Michigan Hospitals - Michigan Medicine, Ann Arbor

60612

Rush University Medical Center Investigator Pharmacy, Chicago

Rush University Medical Center, Chicago

University of Illinois Clinical Research Center (CRC), Chicago

University of Illinois Hospital and Health Sciences System(UI Health), Chicago

72202

Arkansas Children's Hospital, Little Rock

77004

UT Physicians Comprehensive Sickle Cell Clinic, Houston

77030

McGovern Medical School/Health Science Center Houston, Houston

Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy, Houston

Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU), Houston

UT Physicians Comprehensive Sickle Cell Clinic, Houston

80138

DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria, Napoli

"DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria Luigi Vanvitel", Napoli

UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria, Napoli

"UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria Luigi Vanvitelli", Napoli

"UOC Radiologia Azienda Ospedaliera Universitaria Luigi Vanvitelli", Napoli

82943

Prince Mohammed bin Nasser Hospital, Jizan

85016

Phoenix Children's Hospital, Phoenix

92868

UCI Center for clinical research, Orange

93000

Hôpital Avicenne, Bobigny

93053

Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation, Regensburg

94010

Hôpital Henri Mondor, Créteil

94609

UCSF Benioff Children's Hospital, Oakland, Oakland

100254

Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital, Lagos

200001

Sociedad de Oncologia y hematologia del Cesar S.A.S., Valledupar

460000

University of Nigeria Teaching Hospital, Enugu

540242

University of Calabar Teaching Hospital, Calabar

700233

Aminu Kano Teaching Hospital, Kano

800212

Barau Dikko Teaching Hospital/Kaduna State University, Kaduna

900211

National Hospital Abuja, Abuja

902101

University of Abuja Teaching Hospital, Gwagwalada

1100011

Ahmadu Bello University Teaching Hospital, Zaria

92868-3201

UC Irvine Health, Orange

06030-1163

Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell, Farmington

60612-4333

Hospital Pharmacy Services- Investigational Drug Services, Chicago

02215

Dana-Farber Cancer Institute IDS Pharmacy, Boston

Dana-Farber Cancer Institute, Boston

41253-190

Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael, Salvador

30130-100

Hospital das Clinicas da Universidade Federal de Minas Gerais, Belo Horizonte

30130-110

Hemocentro de Belo Horizonte - Fundacao Hemominas, Belo Horizonte

50070-460

Multihemo Serviços Médicos S/A, Recife

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

14051-140

Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto

15090-000

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto

01323-903

Comite de Etica em Pesquisa - CEP do Hospital Alemao Oswaldo Cruz/ SP, São Paulo

20211-030

Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO, Rio de Janeiro

01232-010

Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A, São Paulo

05403-000

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo-HCFMUSP, São Paulo

08270-070

Casa de Saúde Santa Marcelina, São Paulo

08270-120

CEPEC-Centro de Pesquisa Clinica, São Paulo

080020

Clinica de la Costa Ltda., Barranquilla

Organizacion Clinica Bonnadona Prevenir S.A.S., Barranquilla

Unknown

Sickle-Cell Office, Directorate of Child Health, Komfo Anokye Teaching Hospital, Kumasi

American University of Beirut Medical Center, Hamra

Nini Hospital, Tripoli

NIMR-Mbeya Medical Research Center, Mbeya

00100

Gertrude's Children Hospital, Nairobi

Kenya Medical Research Institute- Center for Respiratory Disease Research, Nairobi

00200

Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES), Nairobi

06230

Hacettepe University, Ankara

01250

Baskent University Hospital, Adana

01130

Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji, Adana

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust, London

SE5 9RS

King's College Hospital NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY