RCT of Tocilizumab for Anti-MDA5+DM

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07377058
Status
Recruiting
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Conditions

  • Dermatomyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — BIOLOGICAL
    Tocilizumab is a humanized monoclonal antibody targeting the IL-6 receptor, exerting therapeutic effects by specifically blocking the IL-6 signaling pathway.
  • Standard medical treatment — DRUG
    Standard medical treatment for patients with anti-MDA5+ dermatomyositis

Study Details

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

Key Dates

Start date
Nov 1, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TCZ
  • Placebo Comparator: Placebo

Primary Outcome Measure

TIS improvement [ Time Frame: at Week 16 of treatment ]

Central Contacts

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