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Sickle cell drug inclacumab safety checked in long-term study

NCT ID NCT05348915

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety of inclacumab in people with sickle cell disease who have already taken the drug in a previous study. It tracks side effects and how often pain crises occur. The goal is to see if long-term use is safe and helps control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

242 people

The number who actually took part.

Started

Mar 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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: 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 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.

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Conditions

The condition(s) this trial relates to.

hematologic disorder sickle cell disease Vaso-Occlusive Crises

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease Vaso-occlusive crisis Vaso-occlusive pain episode in sickle cell disease

Contacts and locations

Locations

  • Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji

    Adana, 01130, Turkey (Türkiye)

  • Ahmadu Bello University Teaching Hospital

    Zaria, Kaduna State, 810105, Nigeria

  • American University of Beirut Medical Center

    Hamra, Beirut, Lebanon

  • Aminu Kano Teaching Hospital

    Kano, 700223, Nigeria

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Barau Dikko Teaching Hospital/Kaduna State University

    Kaduna, 800212, Nigeria

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

    Adana, 01250, Turkey (Türkiye)

  • Brigham And Woman's Hospital

    Boston, Massachusetts, 02115, United States

  • CEPEC-Centro de Pesquisa Clinica

    São Paulo, 08270-120, Brazil

  • Casa de Saude Santa Marcelina

    São Paulo, 08270-070, Brazil

  • Clinica de la Costa Ltda.

    Barranquilla, Atlántico, 080020, Colombia

  • DUMC Investigational Drug Services Pharmacy

    Durham, North Carolina, 27710, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute IDS Pharmacy

    Boston, Massachusetts, 02215, United States

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

    Lagos, 100254, Nigeria

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

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

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Gertrude's Children's Hospital

    Nairobi, 00100, Kenya

  • Hacettepe University Ihsan Dogramaci Children Hospital

    Ankara, 06430, Turkey (Türkiye)

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

    Ribeirão Preto, São Paulo, 14051-140, Brazil

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

    São Paulo, 01232-010, Brazil

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO

    Rio de Janeiro, 20211-030, Brazil

  • International Cancer Institute

    Eldoret, 30100, Kenya

  • Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • KEMRI/CRDR Siaya Clinical Research Annex

    Kisumu, Siaya County, 40600, Kenya

  • Kenya Medical Research Institute - Centre for Respiratory Disease Research

    Nairobi, 00100, Kenya

  • McGovern Medical School at UTHealth

    Houston, Texas, 77030, United States

  • Multihemo Servicos Medicos S/A

    Recife, Pernambuco, 50070-460, Brazil

  • National Hospital Abuja

    Abuja, Federal Capital Territory, 900211, Nigeria

  • National Institute for Medical Research (NIMR)

    Dar es Salaam, 11101, Tanzania

  • Nini Hospital

    Tripoli, North Lebanon, Lebanon

  • Prince Mohammed bin Nasser Hospital

    Jizan, Southern, 82943, Saudi Arabia

  • Sociedad de Oncología y hematología del Cesar

    Valledupar, Cesar Department, 200001, Colombia

  • South Alabama Medical Science Foundation

    Mobile, Alabama, 36606, United States

  • Strada Patient Care Center, Pediatric Hematology

    Mobile, Alabama, 36604, United States

  • Strathmore University CREATES

    Nairobi, 00200, Kenya

  • Sultan Qaboos University Hospital

    Muscat, 123, Oman

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • UConn-Neag Comprehensive Cancer Center

    Farmington, Connecticut, 06030, United States

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

    Houston, Texas, 77030, United States

  • UT Physicians Comprehensive Sickle Cell Center Houston

    Houston, Texas, 77030, United States

  • University of Abuja Teaching Hospital

    Gwagwalada, Federal Capital Territory, 902101, Nigeria

  • University of Calabar Teaching Hospital

    Calabar, Cross River State, 540242, Nigeria

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

    Chicago, Illinois, 60612, United States

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

    Chicago, Illinois, 60612, United States

  • University of Michigan Hospitals - Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • University of Nigeria Teaching Hospital

    Enugu, 460000, Nigeria

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

    Mobile, Alabama, 36604, United States

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