Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis

Summary

This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).

Timeline

Start

2021-11-19

Primary completion

2023-10-26

Completion

2024-05-08

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision”

registry analysis (superiority test); RCP: Ravulizumab vs RCP: Placebo; p = 0.4192; Difference in response rates -15.38 (80% CI -38.55 to 8.48); NCT04999020 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ravulizumab	Monoclonal antibody	—	Intravenous

Indications