A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

Phase 2 Completed 95 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.

Timeline

Start: 2022-03-09
Primary completion: 2025-06-11
Completion: 2026-04-09

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Crovalimab	Monoclonal antibody	680 mg	Intravenous
Subject	Crovalimab	Monoclonal antibody	1020 mg	Intravenous

A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

Summary

Timeline

Drugs

Indications