Ravulizumab versus Placebo in Adult Participants with Dermatomyositis

Completed

• Conditions: Dermatomyositis

• Registration Number: jRCT2031210681
• Lead Sponsor: Alexion Pharma GK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-18
• Study Start: 2022-12-21
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

-Meet 2017 ACR/EULAR classification criteria for definite or probable DM
-Participants who have an inadequate response or are intolerant to 2 or more DM treatments, including systemic glucocorticoids or ISTs (eg azathioprine, methotrexate, rituximab, IVIg) either in combination or as monotherapy.

Exclusion Criteria

Participants with significant muscle damage (eg, severe muscle atrophy, end stage muscle disease, MRI with severe atrophy or fibrofatty replacement) as per investigator opinion.

History of N meningitidis infection.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
IMACS-TIS (TIS40) >= 20-point improvement response at Week 26	Week 26	Proportion of participants with a >= 20-point improvement response on IMACS-TIS (TIS40) at Week 26 of the Randomized Controlled Period
IMACS-TIS (TIS40) >= 20-point improvement response at Week 50	Week 50	Proportion of participants with a >= 20-point improvement response on IMACS-TIS (TIS40) at Week 50 as per defined composite estimand of the Randomized Controlled Period

Secondary Outcome Measures

Name	Time	Method
Time to first CDASI Activity Score improvement		minimally clinically important differences [MCID] = 7-point improvement