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

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.

Timeline

Start

2021-10-04

Primary completion

2024-06-06

Completion

2024-06-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Inclacumab vs Placebo; p = 0.6967; Rate ratio 0.95 (95% CI 0.71 to 1.25); Negative binomial regression model NCT04935879 ↗

Drugs

Indications