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A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

NCT06284954 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-25

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM).

The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).

Conditions

  • Dermatomyositis
  • Myositis

Interventions

BIOLOGICAL

Empasiprubart IV

Intravenous infusion with Empasiprubart IV

OTHER

Placebo IV

Intravenous infusion with Placebo IV

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Greece
  • Italy
  • Moldova
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284954 on ClinicalTrials.gov