CompletedPhase 3

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

United States241 participantsStarted 2021-10-04

Plain-language summary

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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype).
✓. 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:
✓. 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.

Exclusion criteria

✕. 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.).

What they're measuring

Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48

Timeframe: Randomization (Day 1) up to Week 48

Trial details

NCT IDNCT04935879

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-06

Results submitted2025-10-30

View on ClinicalTrials.gov More Sickle Cell Disease trials