Phase
Condition
Hematological Disorders
Red Blood Cell Disorders
Sickle Cell Disease
Treatment
Placebo
Inclacumab
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, orHbSB+ thalassemia genotype). Documentation of SCD genotype is required and may be based on documented history oflaboratory testing or confirmed by laboratory testing during Screening.
Participant is male or female, ≥ 12 years of age at the time of informed consent.
Participant has experienced between 2 and 10 VOCs within the 12 months prior to theScreening Visit as determined by documented medical history. A prior VOC is definedas an acute episode of pain which:
Has no medically determined cause other than a vaso-occlusive event, and
Results in a visit to a medical facility (hospital, emergency department,urgent care center, outpatient clinic, or infusion center) or results in aremote contact with a healthcare provider; and
Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatorydrugs (NSAIDs), or an increase in treatment with oral narcotics.
Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visitand expected to continue with the stabilized regimen throughout the course of thestudy.
Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) mustbe on a stable dose for at least 30 days prior to the Screening Visit and expectedto continue with the stabilized regimen throughout the course of the study.
Exclusion
Exclusion Criteria:
Participant is receiving regularly scheduled red blood cell (RBC) transfusiontherapy (also termed chronic, prophylactic, or preventative transfusion).
Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days priorto the Screening Visit
Participant weighs > 133 kg (292 lbs.).
Other protocol-defined Inclusion/Exclusion may apply.
Study Design
Study Description
Connect with a study center
Hospital São Rafael
Salvador, Bahia 40110
BrazilActive - Recruiting
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Bahia 41253-190
BrazilSite Not Available
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador 3450554, Estado de Bahia 3471168 41253-190
BrazilSite Not Available
Hemocentro de Belo Horizonte - Fundacao Hemominas
Belo Horizonte, MG 30130-110
BrazilSite Not Available
Hospital das Clinicas da Universidade Federal de Minas Gerais
Belo Horizonte, MG 30130-100
BrazilSite Not Available
Multihemo Servicos Medicos S/A
Recife, Pernambuco 50070
BrazilActive - Recruiting
Multihemo Serviços Médicos S/A
Recife, Pernambuco 50070-460
BrazilSite Not Available
Multihemo Serviços Médicos S/A
Recife 3390760, Pernambuco 3392268 50070-460
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS 90035-903
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande Do Sul 90035
BrazilActive - Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre 3452925, Rio Grande do Sul 3451133 90035-903
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Sao Jose do Rio Preto, SAO Paulo 15090-000
BrazilSite Not Available
Comite de Etica em Pesquisa - CEP do Hospital Alemao Oswaldo Cruz/ SP
Sao Paulo, SP 01323-903
BrazilSite Not Available
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, SÃO Paulo 14051-140
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José Do Rio Preto
São José Do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto 3451328, São Paulo 3448433 14051-140
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto 3448639, São Paulo 3448433 15090-000
BrazilSite Not Available
HEMORIO - Unidade de Pesquisa Clínica
Rio De Janeiro,
BrazilActive - Recruiting
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, 20211-030
BrazilSite Not Available
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
Rio de Janeiro 3451190, 20211-030
BrazilSite Not Available
CEPEC-Centro de Pesquisa Clinica
São Paulo, 08270-120
BrazilSite Not Available
Casa de Saúde Santa Marcelina
São Paulo, 08270-070
BrazilSite Not Available
Hospital Samaritano
São Paulo,
BrazilActive - Recruiting
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
São Paulo, 01232-010
BrazilSite Not Available
Hospital Santa Marcelina
São Paulo,
BrazilActive - Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo-HCFMUSP
São Paulo, 05403-000
BrazilSite Not Available
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403
BrazilActive - Recruiting
CEPEC-Centro de Pesquisa Clinica
São Paulo 3448439, 08270-120
BrazilSite Not Available
Casa de Saúde Santa Marcelina
São Paulo 3448439, 08270-070
BrazilSite Not Available
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
São Paulo 3448439, 01232-010
BrazilSite Not Available
Clinica de la Costa Ltda.
Barranquilla, Atlantico 080020
ColombiaSite Not Available
Organizacion Clinica Bonnadona Prevenir S.A.S.
Barranquilla, Atlántico 080020
ColombiaSite Not Available
Clinica de la Costa Ltda.
Barranquilla 3689147, Atlántico 3689436 080020
ColombiaSite Not Available
Sociedad de Oncologia y hematologia del Cesar S.A.S.
Valledupar, Cesar 200001
ColombiaSite Not Available
Sociedad de Oncologia y hematologia del Cesar S.A.S.
Valledupar 3666304, Cesar Department 3686880 200001
ColombiaSite Not Available
Clinica de la Costa Ltda - PPDS
Barranquilla, 080020
ColombiaActive - Recruiting
Sociedad de Oncología y hematología del Cesar Ltda
Valledupar,
ColombiaActive - Recruiting
Zagazig University Hospital
Zagazig, ASH Sharqia 44519
EgyptSite Not Available
Cairo University Paediatric Hospital - abou el Reesh University Hospital
El-Rashidy Street, ElSayeda Zeinb, Cairo 11617
EgyptSite Not Available
Al Kasr Al Ainy Cairo University Hospital
Elmanial, Cairo Governorate 11562
EgyptSite Not Available
AinShams University Hospital
Cairo, 11588
EgyptSite Not Available
Faculty of Medicine Cairo University
Cairo, 11562
EgyptSite Not Available
AinShams University Hospital
Cairo 360630, 11588
EgyptSite Not Available
Faculty of Medicine Cairo University
Cairo 360630, 11562
EgyptSite Not Available
CHU de Toulouse - IUCT ONCOPOLE
Toulouse, Haute-Garonne 31000
FranceSite Not Available
Hopital Avicenne
Bobigny, Seine-Saint-Denis 93000
FranceActive - Recruiting
Hopital Henri Mondor
Créteil, Val-de-Marne 94010
FranceActive - Recruiting
Hôpital Avicenne
Bobigny, 93000
FranceSite Not Available
Hôpital Henri Mondor
Créteil, 94010
FranceSite Not Available
Hôpital Henri Mondor
Créteil 3022530, 94010
FranceSite Not Available
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse 2972315, 31059
FranceSite Not Available
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse Cedex 9, 31059
FranceSite Not Available
Universitätsklinikum Regensburg
Regensburg, Bayern 93053
GermanyActive - Recruiting
Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Regensburg, 93053
GermanySite Not Available
Sickle-Cell Office, Directorate of Child Health, Komfo Anokye Teaching Hospital
Kumasi, Ashanti
GhanaSite Not Available
E O Ospedali Galliera
Genova, Liguria 16128
ItalyActive - Recruiting
Azienda Ospedale Università Padova
Padova, Veneto 35128
ItalyActive - Recruiting
Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera
Genova, 16128
ItalySite Not Available
S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro Azienda
Genova, 16128
ItalySite Not Available
Azienda Ospedaliera Universitaria (AOU) dell'Università degli Studi della Campania Luigi Vanvitelli
Napoli, 80138
ItalyActive - Recruiting
DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria
Napoli, 80138
ItalySite Not Available
DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitel
Napoli, 80138
ItalySite Not Available
UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria
Napoli, 80138
ItalySite Not Available
UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Napoli, 80138
ItalySite Not Available
UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Napoli, 80138
ItalySite Not Available
Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica
Padova, 35128
ItalySite Not Available
Farmacia Azienda Ospedale Universita Padova
Padova, 35128
ItalySite Not Available
U.O.C. Farmacia Istituto Oncologico Veneto
Padova, 35128
ItalySite Not Available
KEMRI/CRDR Siaya Clinical Research Annex
Siaya, Nyanza 144
KenyaSite Not Available
KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex
Kisumu, Siaya County 180320 40600
KenyaSite Not Available
Strathmore University
Kisumu, Western
KenyaActive - Recruiting
International Cancer Institute
Eldoret, 30100
KenyaSite Not Available
International Cancer Institute (ICI)
Eldoret,
KenyaActive - Recruiting
International Cancer Institute
Eldoret 198629, 30100
KenyaSite Not Available
Gertrude's Children Hospital
Nairobi, 00100
KenyaSite Not Available
Gertrude's Children's Hospital
Nairobi, 42325
KenyaActive - Recruiting
KEMRI CRDR Clinical Research Clinic Nairobi
Nairobi, 0100
KenyaActive - Recruiting
Kenya Medical Research Institute- Center for Respiratory Disease Research
Nairobi, 00100
KenyaSite Not Available
Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)
Nairobi, 00200
KenyaSite Not Available
Gertrude's Children Hospital
Nairobi 184745, 00100
KenyaSite Not Available
Kenya Medical Research Institute- Center for Respiratory Disease Research
Nairobi 184745, 00100
KenyaSite Not Available
Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)
Nairobi 184745, 00200
KenyaSite Not Available
American University of Beirut Medical Center
Hamra, Beirut
LebanonSite Not Available
American University of Beirut Medical Center
Hamra 6274905, Beyrouth 276780
LebanonSite Not Available
Nini Hospital
Tripoli, North Lebanon
LebanonSite Not Available
Nini Hospital
Tripoli 266826, North Lebanon
LebanonSite Not Available
American University of Beirut Medical Center
Beirut,
LebanonSite Not Available
University of Calabar Teaching Hospital
Calabar, Cross River State 540242
NigeriaSite Not Available
University of Calabar Teaching Hospital
Calabar 2346229, Cross River State 2345891 540242
NigeriaSite Not Available
National Hospital Abuja
Abuja, FCT 900211
NigeriaSite Not Available
University of Abuja Teaching Hospital
Gwagwalada, FCT 902101
NigeriaSite Not Available
National Hospital Abuja
Abuja 2352778, Federal Capital Territory 2352776 900211
NigeriaSite Not Available
University of Abuja Teaching Hospital
Gwagwalada 2339863, Federal Capital Territory 2352776 902101
NigeriaSite Not Available
Ahmadu Bello University Teaching Hospital
Zaria, Kaduna 1100011
NigeriaSite Not Available
Ahmadu Bello University Teaching Hospital
Zaria 2317765, Kaduna State 2335722 1100011
NigeriaSite Not Available
Lagos University Teaching Hospital Haematology
Idi Araba, Lagos
NigeriaSite Not Available
University of Abuja Teaching Hospital
Abuja,
NigeriaActive - Recruiting
University of Nigeria
Enugu,
NigeriaActive - Recruiting
University of Nigeria Teaching Hospital
Enugu, 460000
NigeriaSite Not Available
University of Nigeria Teaching Hospital
Enugu 2343279, 460000
NigeriaSite Not Available
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna, 800212
NigeriaSite Not Available
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna 2335727, 800212
NigeriaSite Not Available
Aminu Kano Teaching Hospital
Kano, 700233
NigeriaSite Not Available
Aminu Kano Teaching Hospital
Kano 2335204, 700233
NigeriaSite Not Available
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
Lagos, 100254
NigeriaSite Not Available
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
Lagos 2332459, 100254
NigeriaSite Not Available
Sultan Qaboos University Hospital
Muscat, Al-Khodh
OmanActive - Recruiting
Sultan َQaboos University Hospital
Muscat, 123
OmanSite Not Available
Sultan َQaboos University Hospital
Muscat 287286, 123
OmanSite Not Available
Prince Mohammed bin Nasser Hospital
Jizan, Southern 82943
Saudi ArabiaSite Not Available
Prince Mohammed bin Nasser Hospital
Jizan 105299, Southern 82943
Saudi ArabiaSite Not Available
Prince Mohamed Bin Nasser Hospital
Jazan, 82943
Saudi ArabiaSite Not Available
NIMR-Mbeya Medical Research Center
Mbeya,
TanzaniaSite Not Available
NIMR-Mbeya Medical Research Center
Mbeya 154380,
TanzaniaSite Not Available
Hacettepe University
Ankara, Altindag/sihhiye 06230
TurkeySite Not Available
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
Yenisehir, Mersin 33343
TurkeySite Not Available
Baskent University Hospital
Adana, Yuregir 01250
TurkeySite Not Available
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
Adana, 01130
TurkeySite Not Available
Acibadem Adana Hospital
Adana,
TurkeyActive - Recruiting
Baskent University Medical Faculty Adana Dr. Turgut Noyan Practice and Research Center
Adana, 01120
TurkeyActive - Recruiting
Hacettepe University Ihsan Dogramaci Children's Hospital
Ankara,
TurkeyActive - Recruiting
Mersin University Medical Faculty
Mersin,
TurkeySite Not Available
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
Yenişehir 310403, Mersin 311728 33343
Turkey (Türkiye)Site Not Available
Baskent University Hospital
Adana 325363, Yuregir 01250
Turkey (Türkiye)Site Not Available
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
Adana 325363, 01130
Turkey (Türkiye)Site Not Available
Guy's and St Thomas' NHS Foundation Trust
London, London CITY OF SE1 9RT
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London, London CITY OF SE5 9RS
United KingdomSite Not Available
Guys Hospital
London, SE1 9RT
United KingdomSite Not Available
Kings College Hospital
London,
United KingdomSite Not Available
University of South Alabama Children's and Women's Hospital
Mobile, Alabama 36604
United StatesSite Not Available
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama 36604
United StatesSite Not Available
University of South Alabama Strada Patient Care Center
Mobile, Alabama 36604
United StatesSite Not Available
University of South Alabama Children's and Women's Hospital
Mobile 4076598, Alabama 4829764 36604
United StatesSite Not Available
University of South Alabama Mitchell Cancer Institute
Mobile 4076598, Alabama 4829764 36604
United StatesSite Not Available
University of South Alabama Strada Patient Care Center
Mobile 4076598, Alabama 4829764 36604
United StatesSite Not Available
Phoenix Children's Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753 72202
United StatesSite Not Available
UC Irvine Medical Center
Irvine, California 92868
United StatesSite Not Available
UCSF Benioff Children's Hospital
Oakland, California 94609
United StatesActive - Recruiting
UCSF Benioff Children's Hospital, Oakland
Oakland, California 94609
United StatesSite Not Available
UC Irvine Health
Orange, California 92868-3201
United StatesSite Not Available
UCI Center for clinical research
Orange, California 92868
United StatesSite Not Available
UC Irvine Health
Orange 5379513, California 5332921 92868
United StatesSite Not Available
UCI Center for clinical research
Orange 5379513, California 5332921 92868
United StatesSite Not Available
Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell
Farmington, Connecticut 06030-1163
United StatesSite Not Available
University of Connecticut
Farmington, Connecticut 06030
United StatesActive - Recruiting
Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell
Farmington 4834272, Connecticut 4831725 06030
United StatesSite Not Available
John S. Curran, MD.,Children's Health Center
Tampa, Florida 33612
United StatesSite Not Available
USF Clinical Investigational Research Pharmacy
Tampa, Florida 33612
United StatesSite Not Available
USF Health Carol & Frank Morsani Center for Advanced Healthcare
Tampa, Florida 33612
United StatesSite Not Available
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida 33606
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
Children's Healthcare of Atlanta
Atlanta, Georgia 30342
United StatesSite Not Available
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia 30322
United StatesSite Not Available
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia 30342
United StatesSite Not Available
Children's Healthcare of Atlanta at Scottish Rite Hospital
Atlanta, Georgia 30342
United StatesActive - Recruiting
Hospital Pharmacy Services- Investigational Drug Services
Chicago, Illinois 60612-4333
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Rush University Medical Center Investigator Pharmacy
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois Clinical Research Center (CRC)
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois Hospital and Health Sciences System(UI Health)
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois at Chicago
Chicago, Illinois 60607
United StatesActive - Recruiting
Hospital Pharmacy Services- Investigational Drug Services
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
Rush University Medical Center Investigator Pharmacy
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
University of Illinois Clinical Research Center (CRC)
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
University of Illinois Hospital and Health Sciences System(UI Health)
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber Cancer Institute IDS Pharmacy
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Dana-Farber Cancer Institute IDS Pharmacy
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan Hospitals - Michigan Medicine
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Jacobi Medical Center
Bronx, New York 10461
United StatesSite Not Available
Erie County Medical Center
Buffalo, New York 14215
United StatesSite Not Available
Jacobi Medical Center
The Bronx 5110266, New York 5128638 10461
United StatesSite Not Available
DUMC Investigational Drug Services Pharmacy
Durham, North Carolina 27710
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
DUMC Investigational Drug Services Pharmacy
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Duke University Medical Center
Durham 4464368, North Carolina 4482348 27705
United StatesSite Not Available
St Jude Children's Research Hospital
Memphis, Tennessee 38105
United StatesActive - Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United StatesSite Not Available
McGovern Medical School/Health Science Center Houston
Houston, Texas 77030
United StatesSite Not Available
Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy
Houston, Texas 77030
United StatesSite Not Available
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
Houston, Texas 77030
United StatesSite Not Available
UT Physicians Comprehensive Sickle Cell Clinic
Houston, Texas 77030
United StatesSite Not Available
University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesActive - Recruiting
McGovern Medical School/Health Science Center Houston
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
UT Physicians Comprehensive Sickle Cell Clinic
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Arthur Davison Childrens's Hospital
Ndola, Copperbelt 10101
ZambiaSite Not Available
Matero Clinical Research Site,
Lusaka, 10101
ZambiaSite Not Available
University Teaching Hospital- Children's Hospital
Lusaka, 10101
ZambiaSite Not Available

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