drugset / Trial / NCT04912869

A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).

NCT04912869

Phase 1 Completed 30 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.

Timeline

Start
2022-03-26
Primary completion
2024-12-23
Completion
2025-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Crovalimab Monoclonal antibody 1000 mg Intravenous
Subject Crovalimab Monoclonal antibody 1500 mg Intravenous

Indications