Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05695950 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis
A Phase 2 study of Dermatomyositis, sponsored by Galapagos.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 20
- Study locations
NCT05695950: Active Phase 2 study of Dermatomyositis, sponsored by Galapagos.
NCT05695950 is a Phase 2 study of Dermatomyositis that is active but no longer recruiting, run by Galapagos. The registered enrollment target is 40 participants, below the 483-participant average among 19 other Dermatomyositis trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05695950, a Phase 2 study of Dermatomyositis, is active but no longer recruiting, sponsored by Galapagos.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The TIS is a score derived from the evaluation of the results from 6 core set measurements (CSMs) of myositis disease activity: Physician's Global Disease Activity Assessment; Patient's Global Disease Activity Assessment; Muscle Manual Test-8 (MMT-8); Health Assessment Questionnaire-Disability Index (HAQ-DI); Enzymes (aldolase, creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH); and Extra-muscular disease activity. The TIS is a
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GLPG3667
Study Locations (20)
Other
- Fundacion Respirar Consultorios Médicos Dr. Doreski - Buenos Aires
- Hospital Cordoba - Córdoba
- Hospital Italiano de La Plata - La Plata
- Framingham Centro Medico - La Plata
- Instituto Medico CER - Quilmes
- UZ Leuven - Leuven
- Enroll SpA - Santiago
- BioMedica Research Group Psicomedica Clinical and Research Group - Santiago
- Clinica de la Costa S.A.S - Barranquilla
- Centro de Investigacion Medico Asistencial S.A.S - Barranquilla
- Healthy Medical Center - Zipaquirá
- Polyclinic Bonifarm - Zagreb
Florida
- New Access Research and Medical Center - Kendall
- Omega Research Orlando, LLC - Orlando
Arizona
- HonorHealth Neurology - Scottsdale
California
- Inland Rheumatology Clinical Trials, Inc. - Upland
Georgia
- Augusta University - Augusta
Minnesota
- St. Paul Rheumatology - Eagan
New York
- Northwell Health, LLC PRIME - Lake Success
Pennsylvania
- Altoona Center for Clinical Research, P.C. - Duncansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-02-27 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT05695950 still lists
NCT05695950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 483-participant average among 19 other Dermatomyositis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Dermatomyositis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05695950 names 20 study sites across 8 states, led by Other, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05695950 about?
NCT05695950 is a clinical study titled "A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis". 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.
What is the current status of trial NCT05695950?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-02-27. Estimated completion is 2026-04.
What conditions does trial NCT05695950 study?
This clinical trial studies the following conditions: Dermatomyositis.
What interventions are being tested in trial NCT05695950?
The interventions under investigation include: Placebo (DRUG), GLPG3667 (DRUG).
Who is sponsoring clinical trial NCT05695950?
This trial is sponsored by Galapagos, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05695950 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dermatomyositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05695950's enrollment target sits among peer trials
40 13th of 19 higher than 7 of 19 other Dermatomyositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatomyositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
RECRUITING · Phase 2
-
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
RECRUITING · Phase 2
-
Intralesional Injection of STS in Treatment of Calcinosis
RECRUITING · Phase 2
-
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
ACTIVE NOT RECRUITING · Phase 2
-
Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI