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

Last updated: August 4, 2025
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

3

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Inclacumab

Clinical Study ID

NCT05348915
GBT2104-133
C5361003
LBCTR2021074838
PACTR202108532761448
2020-005289-32
020-005289-32
  • Ages > 12
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants who meet all the following criteria will be eligible for study enrollment:

  1. Male or female participant with SCD who participated and received study drug in aGBT-Sponsored inclacumab clinical study.

  2. Participant has completed the originating inclacumab study within 30 calendar daysof the Day 1 Visit. Participants who discontinued study drug in the originatingstudy due to a non-study drug-related AE, but who remained on study, may be eligiblefor treatment in this study provided the AE does not pose a risk for treatment withinclacumab.

  3. Female participants of childbearing potential are required to have a negative urinepregnancy test prior to dosing on Day 1. Note: Female participants who become of childbearing potential during the study mustbe willing to have a negative urine pregnancy test to remain in the study.

  4. If sexually active, female participants of childbearing potential must consistentlyuse highly effective methods of contraception consistently throughout the study andfor at least 165 days after the last dose of study drug. If sexually active, maleparticipants must use barrier methods of contraception until 165 days after the lastdose 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 theparticipant's assent (where applicable) must be obtained based on local requirement.

Exclusion

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:

  1. Female participant who is breastfeeding or pregnant.

  2. Participant had an infusions-related reaction (IRR) in the originating inclacumabclinical 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, interferewith compliance, or preclude informed consent.

Study Design

Total Participants: 147
Treatment Group(s): 1
Primary Treatment: Inclacumab
Phase: 3
Study Start date:
March 29, 2022
Estimated Completion Date:
November 04, 2028

Study Description

The study will include approximately 520 adult and adolescent participants (≥ 12 years of age) with SCD.

All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.

Connect with a study center

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

    Salvador, Bahia 41253-190
    Brazil

    Site Not Available

  • Hemocentro de Belo Horizonte - Fundacao Hemominas

    Belo Horizonte, MG 30130-110
    Brazil

    Site Not Available

  • Hospital das Clinicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais 30130-100
    Brazil

    Site Not Available

  • Multihemo Servicos Medicos S/A

    Recife, PE 50070-460
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, RIO Grande DO SUL 90035-903
    Brazil

    Site Not Available

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

    Sao Jose do Rio Preto, SAO Paulo 15090-000
    Brazil

    Site Not Available

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

    Ribeirão Preto, SÃO Paulo 14051-140
    Brazil

    Site Not Available

  • Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO

    Rio de Janeiro, 20211-030
    Brazil

    Site Not Available

  • CEPEC-Centro de Pesquisa Clinica

    São Paulo, 08270-120
    Brazil

    Site Not Available

  • Casa de Saude Santa Marcelina

    São Paulo, 08270-070
    Brazil

    Site Not Available

  • Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A

    São Paulo, 01232-010
    Brazil

    Site Not Available

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Clinica de la Costa Ltda.

    Barranquilla, Atlantico 080020
    Colombia

    Site Not Available

  • Sociedad de Oncología y hematología del Cesar

    Valledupar, Cesar 200001
    Colombia

    Site Not Available

  • Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation

    Regensburg, 93053
    Germany

    Site Not Available

  • Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera

    Genova, 16128
    Italy

    Site Not Available

  • S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro

    Genova, 16128
    Italy

    Site Not Available

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

    Napoli, 80138
    Italy

    Site Not Available

  • UO di Farmacia Clinica,Dipartimento di Medicina Sperimentale

    Napoli, 80138
    Italy

    Site Not Available

  • UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

    Napoli, 80138
    Italy

    Site Not Available

  • UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

    Napoli, 80138
    Italy

    Site Not Available

  • Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica

    Padova, 35128
    Italy

    Site Not Available

  • Farmacia Azienda Ospedale Universita Padova

    Padova, 35128
    Italy

    Site Not Available

  • U.O.C. Farmacia Istituto Oncologico Veneto

    Padova, 35128
    Italy

    Site Not Available

  • KEMRI/CRDR Siaya Clinical Research Annex

    Kisumu, Siaya 40600
    Kenya

    Site Not Available

  • International Cancer Institute

    Eldoret, 30100
    Kenya

    Site Not Available

  • International Cancer Institute (ICI)

    Eldoret, 30100
    Kenya

    Site Not Available

  • Gertrude's Children's Hospital

    Nairobi, 00100
    Kenya

    Site Not Available

  • KEMRI CRDR Clinical Research Clinic Nairobi

    Nairobi,
    Kenya

    Site Not Available

  • Kenya Medical Research Institute - Centre for Respiratory Disease Research

    Nairobi, 00100
    Kenya

    Site Not Available

  • Strathmore University CREATES

    Nairobi, 00200
    Kenya

    Site Not Available

  • KEMRI/CRDR Siaya Clinical Research Annex

    Siaya,
    Kenya

    Site Not Available

  • American University of Beirut Medical Center

    Hamra, Beirut
    Lebanon

    Site Not Available

  • Nini Hospital

    Tripoli, North Lebanon
    Lebanon

    Site Not Available

  • American University of Beirut Medical Center

    Beirut,
    Lebanon

    Site Not Available

  • University of Calabar Teaching Hospital

    Calabar, Cross River State 540242
    Nigeria

    Site Not Available

  • National Hospital Abuja

    Abuja, FCT 900211
    Nigeria

    Site Not Available

  • University of Abuja Teaching Hospital

    Gwagwalada, FCT 902101
    Nigeria

    Site Not Available

  • Ahmadu Bello University Teaching Hospital

    Zaria, Kaduna 810105
    Nigeria

    Site Not Available

  • University of Nigeria Teaching Hospital

    Enugu, 460000
    Nigeria

    Site Not Available

  • Barau Dikko Teaching Hospital/Kaduna State University

    Kaduna, 800212
    Nigeria

    Site Not Available

  • Aminu Kano Teaching Hospital

    Kano, 700223
    Nigeria

    Site Not Available

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

    Lagos, 100254
    Nigeria

    Site Not Available

  • Lagos University Teaching Hospital Haematology

    Suru Lere,
    Nigeria

    Site Not Available

  • Sultan Qaboos University Hospital

    Muscat, 123
    Oman

    Site Not Available

  • Prince Mohammed bin Nasser Hospital

    Jizan, Southern 82943
    Saudi Arabia

    Site Not Available

  • NIMR-Mbeya Medical Research Center

    Mbeya,
    Tanzania

    Site Not Available

  • Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji

    Adana, 01130
    Turkey

    Site Not Available

  • Baskent University Adana Appl. and Research Central, Yuregir Baskent Hospital Hematology

    Adana, 01250
    Turkey

    Site Not Available

  • Baskent University Medical Faculty Adana Practice and Research Center

    Adana, 01250
    Turkey

    Site Not Available

  • Hacettepe University Ihsan Dogramaci Children Hospital

    Ankara, 06430
    Turkey

    Site Not Available

  • Hacettepe University Ihsan Dogramaci Children's Ho

    Ankara, 06230
    Turkey

    Site Not Available

  • Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi

    Mersin, 33343
    Turkey

    Site Not Available

  • Strada Patient Care Center, Pediatric Hematology

    Mobile, Alabama 36604
    United States

    Site Not Available

  • University of South Alabama Children's and Women's Hospital

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Children's Hospital and Research Center at Oakland

    Oakland, California 94609-1809
    United States

    Site Not Available

  • UC Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • UConn-Neag Comprehensive Cancer Center

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • John S Curran,MD, Children's Health Center/Children's Medical Center (CMS)

    Tampa, Florida 33612
    United States

    Site Not Available

  • St. Joseph's Hospital

    Tampa, Florida 33607
    United States

    Site Not Available

  • USF Health Carol and Frank Morsani Center for Advanced Healthcare

    Tampa, Florida 33612
    United States

    Site Not Available

  • USF Health South Tampa Center for Advanced Healthcare (STC)

    Tampa, Florida 33606
    United States

    Site Not Available

  • University of South Florida, Department of Pediatrics

    Tampa, Florida 33606
    United States

    Site Not Available

  • University of Illinois Hospital and Health Sciences System (UI Health)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Illinois Hospital and Health Systems

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Illinois at Chicago (UIC) Clinical Research Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Brigham And Woman's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute IDS Pharmacy

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Hospitals - Michigan Medicine

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Jacobi Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Erie Country Medical Center

    Buffalo, New York 14215
    United States

    Site Not Available

  • DUMC Investigational Drug Services Pharmacy

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • McGovern Medical School at UTHealth

    Houston, Texas 77030
    United States

    Site Not Available

  • UT Health Science Center at Houston - Clinical Research Unit at Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • UT Physicians Comprehensive Sickle Cell Center Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030-1501
    United States

    Site Not Available

  • University of Texas Health Science Center of Houston -6410 Fannin St Ste 600

    Houston, Texas 77030-1501
    United States

    Site Not Available

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