A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises

Stopped early · Phase 3 · Has a placebo group

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

In brief

This Phase 3 study will assess the safety and efficacy of a single dose of inclacumab, a P-selectin inhibitor, for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD). Participants will be randomized to receive either inclacumab or placebo.

Key facts

Study ID

NCT04927247

Run by

Pfizer

People needed

72

Starts

2021-12-09

Expected to finish

2023-11-24

Last updated by the study team

2024-12-11

Who can join

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

You may qualify if…

• Participant has an index VOC. The index VOC is any VOC that required admission to a healthcare facility and treatment with parenteral pain medication. An admission for the index VOC includes:
• A hospital admission, or
• An admission to an emergency room, observation unit, or infusion center for ≥ 12 hours, or
• 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period
• for an acute episode of pain with no other cause other than a vaso- occlusive event that includes the following:
• Uncomplicated VOC,
• Acute chest syndrome (ACS),
• Acute hepatic sequestration,
• Acute splenic sequestration, or
• Priapism.
• Participant has a confirmed diagnosis of SCD (any genotype). Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing at Baseline.
• Participant is male or female, ≥ 12 years of age at the time of informed consent.
• Participant has experienced between 2 and 10 VOCs within the 12 months prior to Screening as determined by documented medical history. The index VOC is not to be considered as one of the 2 to 10 events. A prior VOC is defined as an acute episode of pain that:
• Has no medically determined cause other than a vaso-occlusive event, and
• Results in a visit to a healthcare 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.
• Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to Screening and expected to continue with the stabilized regimen throughout the course of the study.
• Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to Screening and expected to continue with the stabilized regimen throughout the course of the study.

You may not qualify if…

• Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
• Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to Screening.
• Participant weighs > 133 kg (292 lbs.).
• Other protocol-defined Inclusion/Exclusion may apply.

Where it is running

• University of South Alabama Children's and Women's Hospital — Mobile, Alabama, United States
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• UCSF Benioff Children's Hospital, Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• St. Joseph's Hospital — Tampa, Florida, United States
• University of Michigan Hospitals - Michigan Medicine — Ann Arbor, Michigan, United States
• Functional Fluidics, Inc. — Detroit, Michigan, United States
• Alliance for Childhood Diseases dba Cure 4 The Kids Foundation — Las Vegas, Nevada, United States
• Erie County Medical Center — Buffalo, New York, 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
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• PPD Bioanalytical — Richmond, Virginia, 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 Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
• Fundação Faculdade Regional de Medicina de São José do Rio Preto — São José do Rio Preto, São Paulo, Brazil
• Casa de Saude Santa Marcelina — São Paulo, São Paulo, Brazil
• Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO — Rio de Janeiro, Brazil
• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP — São Paulo, Brazil
• CEPEC-Centro de Pesquisa Clinica — São Paulo, Brazil
• Strada Patient Care Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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