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

NCT05695950 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Galapagos Study Director · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2025-10-13
Completion
2026-04-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • France
  • Germany
  • Italy
  • Mexico
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05695950 on ClinicalTrials.gov