A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease
NCT ID: NCT05348915
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
242 participants
INTERVENTIONAL
2022-03-29
2025-11-07
Brief Summary
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Detailed Description
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All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inclacumab 30 mg/kg
Inclacumab 30 mg/kg administered intravenously (IV)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
2. Participant has completed the originating inclacumab study within 30 calendar days of the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related AE, but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.
3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.
Note: Female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study.
4. If sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.
5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement.
Exclusion Criteria
2. Participant had an infusions-related reaction (IRR) in the originating inclacumab clinical study.
3. Participant withdrew consent from the originating inclacumab clinical study.
4. Participant was lost to follow-up from the originating inclacumab clinical study.
5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Strada Patient Care Center, Pediatric Hematology
Mobile, Alabama, United States
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, United States
South Alabama Medical Science Foundation
Mobile, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
UC Irvine Medical Center
Orange, California, United States
UConn-Neag Comprehensive Cancer Center
Farmington, Connecticut, United States
University of Illinois at Chicago (UIC) Clinical Research Center
Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences System (UI Health)
Chicago, Illinois, United States
Brigham And Woman's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute IDS Pharmacy
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan, United States
Jacobi Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
DUMC Investigational Drug Services Pharmacy
Durham, North Carolina, United States
McGovern Medical School at UTHealth
Houston, Texas, United States
UT Health Science Center at Houston - Clinical Research Unit at Memorial Hermann Hospital
Houston, Texas, United States
UT Physicians Comprehensive Sickle Cell Center Houston
Houston, Texas, United States
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, Brazil
Multihemo Servicos Medicos S/A
Recife, Pernambuco, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, , Brazil
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
São Paulo, , Brazil
Casa de Saude Santa Marcelina
São Paulo, , Brazil
CEPEC-Centro de Pesquisa Clinica
São Paulo, , Brazil
Clinica de la Costa Ltda.
Barranquilla, Atlántico, Colombia
Sociedad de Oncología y hematología del Cesar
Valledupar, Cesar Department, Colombia
KEMRI/CRDR Siaya Clinical Research Annex
Kisumu, Siaya County, Kenya
International Cancer Institute
Eldoret, , Kenya
Gertrude's Children's Hospital
Nairobi, , Kenya
Kenya Medical Research Institute - Centre for Respiratory Disease Research
Nairobi, , Kenya
Strathmore University CREATES
Nairobi, , Kenya
American University of Beirut Medical Center
Hamra, Beyrouth, Lebanon
Nini Hospital
Tripoli, North Lebanon, Lebanon
University of Calabar Teaching Hospital
Calabar, Cross River State, Nigeria
National Hospital Abuja
Abuja, Federal Capital Territory, Nigeria
University of Abuja Teaching Hospital
Gwagwalada, Federal Capital Territory, Nigeria
Ahmadu Bello University Teaching Hospital
Zaria, Kaduna State, Nigeria
University of Nigeria Teaching Hospital
Enugu, , Nigeria
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna, , Nigeria
Aminu Kano Teaching Hospital
Kano, , Nigeria
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
Lagos, , Nigeria
Sultan Qaboos University Hospital
Muscat, , Oman
Prince Mohammed bin Nasser Hospital
Jizan, Southern, Saudi Arabia
National Institute for Medical Research (NIMR)
Dar es Salaam, , Tanzania
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
Adana, , Turkey (Türkiye)
Baskent University Adana Appl. and Research Central, Yuregir Baskent Hospital Hematology
Adana, , Turkey (Türkiye)
Hacettepe University Ihsan Dogramaci Children Hospital
Ankara, , Turkey (Türkiye)
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5361003
Identifier Type: OTHER
Identifier Source: secondary_id
2020-005289-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GBT2104-133
Identifier Type: -
Identifier Source: org_study_id