NCT05695950

A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3667 Once Daily for 24 Weeks in Adult Subjects With Dermatomyositis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis (DM), followed by an open-label extension (OLE) period until Week 48.

Conditions

• Dermatomyositis

Interventions

Type	Name	Description
DRUG	GLPG3667	GLPG3667 capsules will be administered per dose and schedule specified in the arm description.
DRUG	Placebo	Placebo matching to GLPG3667 capsules will be administered per schedule specified in the arm description.

Timeline

• Start date: 2023-02-27
• Primary completion: 2025-10-13
• Completion: 2026-04-01
• First posted: 2023-01-25
• Last updated: 2025-12-23

Locations

54 sites across 15 countries: United States, Argentina, Belgium, Chile, Colombia, Croatia, Czechia, France, Germany, Italy, Mexico, Poland, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study