A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Completed · Phase 3 · Has a placebo group

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

In brief

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

Key facts

Study ID

NCT04935879

Run by

Pfizer

People needed

241

Starts

2021-10-04

Expected to finish

2024-06-06

Last updated by the study team

2025-12-02

Who can join

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

You may qualify if…

• 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.
• 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 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.
• 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.
• 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.

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 the Screening Visit
• Participant weighs > 133 kg (292 lbs.).
• Other protocol-defined Inclusion/Exclusion may apply.

Where it is running

• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• University of South Alabama Strada Patient Care Center — Mobile, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• UC Irvine Health — Orange, California, United States
• UCI Center for clinical research — Orange, California, United States
• Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell — Farmington, Connecticut, United States
• Hospital Pharmacy Services- Investigational Drug Services — Chicago, Illinois, United States
• Rush University Medical Center Investigator Pharmacy — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Illinois Clinical Research Center (CRC) — Chicago, Illinois, United States
• University of Illinois Hospital and Health Sciences System(UI Health) — Chicago, Illinois, 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/Health Science Center Houston — Houston, Texas, United States
• Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy — Houston, Texas, United States
• Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU) — Houston, Texas, United States
• UT Physicians Comprehensive Sickle Cell Clinic — Houston, Texas, United States
• Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael — Salvador, Estado de Bahia, Brazil
• Multihemo Serviços Médicos S/A — Recife, Pernambuco, Brazil
• Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
• University of South Alabama Children's and Women's Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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