A Randomized, Double-Blind, Placebo-Controlled Clinical Study on the Efficacy and Safety of Tocilizumab in the Treatment of Anti-MDA5 Antibody-Positive Adult Dermatomyositis (PROMIS-MDA5)

NCT07377058 NA RECRUITING

The goal of this clinical trial is to learn if tocilizumab works to treat anti-MDA5+ dermatomyositis (anti-MDA5+DM) in adults. It will also learn about the safety of tocilizumab. The main questions it aims to answer are: Does tocilizumab improve patients' clinical symptoms? Does tocilizumab improve patients' respiratory failure? What medical problems do participants have when taking tocilizumab? Researchers will compare tocilizumab to a placebo (a look-alike substance that contains no drug) to see if tocilizumab works to treat patients with anti-MDA5+ DM. Participants will: Take tocilizumab or a placebo every two weeks for 2 months Visit the clinic once every 2 weeks for checkups and tests

Details

Lead sponsor	Peking Union Medical College Hospital
Phase	NA
Status	RECRUITING
Enrolment	110
Start date	2025-11-01
Completion	2026-10

Conditions

• Dermatomyositis

Interventions

• Tocilizumab
• Standard medical treatment

Primary outcomes

• TIS improvement — at Week 16 of treatment
  Proportion of patients achieving minimal improvement in Total Improvement Score (TIS≥20)
• ILD improvement — at Week 16
  Change in PaO2/FiO2 ratio from baseline (patients with concomitant ILD)

Countries

China