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New drug aims to cut sickle cell pain episodes

NCT ID NCT04935879

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 tested a drug called inclacumab in about 240 people with sickle cell disease who experience painful vaso-occlusive crises. Participants received either inclacumab or a placebo by IV infusion. The main goal was to see if inclacumab could reduce the number of these painful episodes over 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inclacumab (a P-selectin inhibitor given by IV infusion)
What this could lead to
If it works, inclacumab could become a new treatment to reduce the frequency of painful crises in people with sickle cell disease.
What could go wrong
This is a completed Phase 3 trial, but results are not yet fully published. The drug may not show a meaningful benefit over placebo, and side effects are possible.

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

241 people

The number who actually took part.

Started

Oct 2021

Finished

Jun 2024

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: 1. Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype). Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening. 2. Participant is male or female, ≥ 12 years of age at the time of informed consent. 3. Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as 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 a remote contact with a healthcare provider; and * Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. 4. 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 Visit and expected to continue with the stabilized regimen throughout the course of the study. 5. Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study. Exclusion Criteria: 1. Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion). 2. Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit 3. Participant weighs \> 133 kg (292 lbs.). Other protocol-defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

hematologic disorder sickle cell disease Sickle Cell Trait 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, 1100011, Nigeria

  • AinShams University Hospital

    Cairo, 11588, Egypt

  • American University of Beirut Medical Center

    Hamra, Beirut, Lebanon

  • Aminu Kano Teaching Hospital

    Kano, 700233, Nigeria

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Barau Dikko Teaching Hospital/Kaduna State University

    Kaduna, 800212, Nigeria

  • Baskent University Hospital

    Adana, Yuregir, 01250, Turkey (Türkiye)

  • CEPEC-Centro de Pesquisa Clinica

    São Paulo, 08270-120, Brazil

  • Casa de Saúde 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

  • Faculty of Medicine Cairo University

    Cairo, 11562, Egypt

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

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

  • Gertrude's Children Hospital

    Nairobi, 00100, Kenya

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

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital Pharmacy Services- Investigational Drug Services

    Chicago, Illinois, 60612, United States

  • 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

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Institut Universitaire du Cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • 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, KEMRI Clinical Research Annex

    Kisumu, Siaya County, 40600, Kenya

  • Kenya Medical Research Institute- Center for Respiratory Disease Research

    Nairobi, 00100, Kenya

  • McGovern Medical School/Health Science Center Houston

    Houston, Texas, 77030, United States

  • Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy

    Houston, Texas, 77030, United States

  • Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)

    Houston, Texas, 77030, United States

  • Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi

    Yenişehir, Mersin, 33343, Turkey (Türkiye)

  • Multihemo Serviços Médicos S/A

    Recife, Pernambuco, 50070-460, Brazil

  • NIMR-Mbeya Medical Research Center

    Mbeya, Tanzania

  • National Hospital Abuja

    Abuja, Federal Capital Territory, 900211, Nigeria

  • Nini Hospital

    Tripoli, North Lebanon, Lebanon

  • Prince Mohammed bin Nasser Hospital

    Jizan, Southern, 82943, Saudi Arabia

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Rush University Medical Center Investigator Pharmacy

    Chicago, Illinois, 60612, United States

  • Sociedad de Oncologia y hematologia del Cesar S.A.S.

    Valledupar, Cesar Department, 200001, Colombia

  • Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)

    Nairobi, 00200, Kenya

  • Sultan َQaboos University Hospital

    Muscat, 123, Oman

  • UC Irvine Health

    Orange, California, 92868, United States

  • UCI Center for clinical research

    Orange, California, 92868, United States

  • UT Physicians Comprehensive Sickle Cell Clinic

    Houston, Texas, 77030, United States

  • Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell

    Farmington, Connecticut, 06030, 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 Clinical Research Center (CRC)

    Chicago, Illinois, 60612, United States

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

    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

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604, United States

  • University of South Alabama Strada Patient Care Center

    Mobile, Alabama, 36604, United States

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Other studies related to the condition(s) this trial covers.