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

Summary

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.

Timeline

Start

2021-12-09

Primary completion

2023-11-24

Completion

2023-11-24

Outcome

Missed primary endpoint

Stopped (Enrollment): “Study was terminated due to poor accrual and associated recrutiment challenges”

registry analysis (other test); Inclacumab 30 mg/kg vs Placebo; p = 0.6302; Difference in percentage 7.9 (95% CI -15.8 to 31.7); Exact Cochran-Mantel-Haenszel test NCT04927247 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inclacumab	Monoclonal antibody	30 mg/kg	Intravenous

Indications