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).

A Phase IB Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Crovalimab	Crovalimab will be administered as a single dose of 1000 milligrams (mg) IV (for participants with a body weight between 40 kilograms (kg) and 100 kg) or 1500 mg IV (for participants with a body weight \>=100 kg).
DRUG	Placebo	Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab

Timeline

• Start date: 2022-03-26
• Primary completion: 2024-12-23
• Completion: 2025-08-15
• First posted: 2021-06-03
• Last updated: 2025-08-26

Locations

16 sites across 10 countries: United States, Brazil, France, Italy, Kenya, Lebanon, Netherlands, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study