A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With Dermatomyositis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508337-14-00

Acronym

ARGX-117-2301

Enrollment

Registered

2024-11-13

Start date

2025-03-18

Completion date

2025-09-04

Last updated

2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis, Myositis

Brief summary

Incidence of adverse events (AEs) at up to 90 weeks., Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE) at up to 25 weeks.

Detailed description

Total Improvement Score (TIS) at weeks 13 and 25.

Interventions

DRUGPlacebo to ARGX-117 IV concentrate solution for infusion

DRUGARGX-117

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs) at up to 90 weeks., Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE) at up to 25 weeks.	—

Secondary

Measure	Time frame
Total Improvement Score (TIS) at weeks 13 and 25.	—

Countries

Greece, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026