A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

Stopped early · Phase 3

Conditions studied: Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in Sickle Cell Disease

In brief

This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.

Key facts

Study ID

NCT05348915

Run by

Pfizer

People needed

242

Starts

2022-03-29

Expected to finish

2025-11-07

Last updated by the study team

2025-12-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who meet all the following criteria will be eligible for study enrollment:
• Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
• 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.
• 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.
• 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.
• 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.

You may not qualify if…

• Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:
• Female participant who is breastfeeding or pregnant.
• Participant had an infusions-related reaction (IRR) in the originating inclacumab clinical study.
• Participant withdrew consent from the originating inclacumab clinical study.
• Participant was lost to follow-up from the originating inclacumab clinical study.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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