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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Total improvement score [TIS] according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria
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 scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM.
Time frame: Week 24
Percentage of Participants With at Least Minimal Improvement According to the ACR/EULAR Criteria
Minimal improvement per ACR/EULAR was defined as TIS of ≥ 20 points. The TIS is a score derived from the evaluation of the results from 6 CSMs of myositis disease activity: Physician's Global Disease Activity Assessment; Patient's Global Disease Activity Assessment; MMT-8; HAQ-DI; Enzymes (aldolase, CK, ALT, AST, and LDH; and Extra-muscular disease activity. The TIS is a scale from 0 to 100 that allows for the discrimination between minimal, moderate and major responders depending on their improvement in the combined 6 CSM.
Time frame: Week 24
Change From Baseline in Modified-Cutaneous DM Disease Area and Severity Index Activity Score (m-CDASI-A) at Week 24
The CDASI is a clinician-scored single page instrument that separately measures activity (m-CDASI-A) and damage (m-CDASI-D) in the skin of DM participants. The m-CDASI-A consists of 3 activity measures (erythema, scale, and erosion/ulceration) assessed over 15 body areas along with the activity of Gottron's papules on hands and activity of periungual changes and alopecia. m-CDASI-A ranges from 0-100. Higher scores indicate more disease activity.
Time frame: Week 24
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HonorHealth Neurology
Scottsdale, Arizona, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
New Access Research and Medical Center
Kendall, Florida, United States
Omega Research Orlando, LLC
Orlando, Florida, United States
Augusta University
Augusta, Georgia, United States
St. Paul Rheumatology
Eagan, Minnesota, United States
Northwell Health, LLC PRIME
Lake Success, New York, United States
Altoona Center for Clinical Research, P.C.
Duncansville, Pennsylvania, United States
Fundacion Respirar Consultorios Médicos Dr. Doreski
Buenos Aires, Argentina
Hospital Cordoba
Córdoba, Argentina
...and 44 more locations
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
The HAQ-DI is a generic rather than a disease-specific instrument, comprised of 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 \[without any difficulty\] to 3 \[unable to do\]. For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8.
Time frame: Week 24
Change from baseline in the manual muscle test (MMT-8) at Week 24
MMT-8 is a set of 8 designated muscles, 7 of them being tested bilaterally (potential score 0-140). Axial (neck flexors) testing is included, so that potential maximum MMT-8 score = 150.
Time frame: Week 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
Time frame: Baseline (Day 1) up to Week 24
Maximum Plasma Concentration (Cmax) of GLPG3667
Time frame: Week 4
Area Under the Plasma Concentration-Time Curve (AUC) of GLPG3667
Time frame: Week 4
Plasma Trough Concentration (Ctrough) at Steady State of GLPG3667
Time frame: Week 2 predose until Week 24