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

NCT05695950 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GLPG3667-CL-2142022-501097-19-00
• Study Type: interventional
• Target: 40
• Locations: 15 countries
• Sites: 54

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 24

Secondary Outcomes (8)

• Percentage of Participants With at Least Minimal Improvement According to the ACR/EULAR Criteria

  Week 24

• Change From Baseline in Modified-Cutaneous DM Disease Area and Severity Index Activity Score (m-CDASI-A) at Week 24

  Week 24

• Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24

  Week 24

• Change from baseline in the manual muscle test (MMT-8) at Week 24

  Week 24

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation

  Baseline (Day 1) up to Week 24

Other Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation

  Baseline (Day 1) up to Week 52

Study Arms (2)

GLPG3667 During DB + During OLE

EXPERIMENTAL

Participants will receive GLPG3667 dose A orally once daily for 24 weeks in the double-blind (DB) treatment period. Eligible participants will roll-over to an open-label extension (OLE) period to receive the same dose for another 24 weeks.

Drug: GLPG3667

Placebo During DB + GLPG3667 During OLE

PLACEBO COMPARATOR

Participants will receive placebo matching to GLPG3667 orally once daily for 24 weeks in the DB treatment period. Eligible participants will roll-over to an OLE period to receive GLPG3667 dose A orally once daily for another 24 weeks.

Drug: GLPG3667; Drug: Placebo

Interventions

GLPG3667 DRUG

GLPG3667 capsules will be administered per dose and schedule specified in the arm description.

GLPG3667 During DB + During OLE; Placebo During DB + GLPG3667 During OLE

Placebo DRUG

Placebo matching to GLPG3667 capsules will be administered per schedule specified in the arm description.

Placebo During DB + GLPG3667 During OLE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has probable or definite DM in accordance with the ACR/EULAR criteria for at least 3 months.
• Participant with DM diagnosed in the 3 years prior to screening must have undergone cancer screening (according to local standard of care or applicable guidelines) within 1 year prior to screening. Note: The evidence of cancer screening must be documented.
• Participant must present objective evidence of active disease as defined by fulfilling 1 of the criteria below (as confirmed by the sponsor):
• DM rash as defined by modified-Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (m-CDASI-A) ≥ 6 at screening, or
• Creatine kinase (CK) \> 4x upper limit of normal (ULN) at screening, or
• muscle biopsy evidence of active disease within 3 months prior to screening (defined as presence of active inflammation in muscle biopsy), or
• muscle magnetic resonance imaging showing active inflammation (edema) of the proximal skeletal muscles within 3 months prior to screening, or
• electromyography showing acute changes, such as spontaneous activity and myopathic changes not explained by other diseases within 3 months prior to screening, or
• any other clinical evidence of active disease as confirmed by the steering committee.
• Participant has reduced muscle strength (defined as Manual Muscle Test-8 \< 142/150) and at least 2 additional abnormal core set measurements out of the following 5 at screening:
• Physician's Global Disease Activity score \> 2/10 cm on the visual analog scale (VAS),
• Patient's Global Disease Activity score \> 2/10 cm on VAS,
• extra-muscular disease activity \> 2/10 cm on VAS,
• Health Assessment Questionnaire-Disability Index score \> 0.25,
• elevated muscle enzymes (e.g. aldolase, CK, ALT, AST, and lactate dehydrogenase) with at least 1 muscle enzyme \> 1.5x ULN.

You may not qualify if:

• Participant has cancer-associated myositis (defined as myositis diagnosed within 2 years of cancer diagnosis with the exception of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ uterine cervical carcinoma that has been excised and cured). Note: At least 1 year for basal cell carcinoma and squamous cell carcinoma or 5 years for in situ uterine cervical carcinoma must have passed since the excision.
• Participant has permanent muscle weakness due to muscle damage (e.g. participant is wheelchair bound or has significant muscle atrophy on magnetic resonance imaging \[MRI\]) or a non-DM cause (drug-induced myopathy, including glucocorticoid-induced myopathy as primary cause of muscle weakness), according to investigator's judgement.
• Participant has taken any prohibited therapies within the defined washout periods before screening, and during screening as listed in the study protocol.
• Open Label Extension : Participant meeting one or more of the criteria at Visit 8 as defined in the protocol, cannot be selected for the OLE period of this clinical study. 1. Participant has total bilirubin \>1.5x ULN; however, participant with an isolated increase in total bilirubin \<3 x ULN due to Gilbert's Syndrome, with normal direct bilirubin, can be enrolled in the OLE period. 2. Participant has AST or ALT \>1.5 x ULN (hepatic injury), or AST or ALT \>=5 x ULN if judged to be of muscular origin (and confirmed by the steering committee) at Visit 7 and Visit 8.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (54)

HonorHealth Neurology

Scottsdale, Arizona, 85251, United States

Location

Inland Rheumatology Clinical Trials, Inc.

Upland, California, 91786, United States

Location

New Access Research and Medical Center

Kendall, Florida, 33186, United States

Location

Omega Research Orlando, LLC

Orlando, Florida, 32808, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

St. Paul Rheumatology

Eagan, Minnesota, 55121, United States

Location

Northwell Health, LLC PRIME

Lake Success, New York, 11042, United States

Location

Altoona Center for Clinical Research, P.C.

Duncansville, Pennsylvania, 16635, United States

Location

Fundacion Respirar Consultorios Médicos Dr. Doreski

Buenos Aires, C1426ABO, Argentina

Location

Hospital Cordoba

Córdoba, X5004CDT, Argentina

Location

Hospital Italiano de La Plata

La Plata, B1900, Argentina

Location

Framingham Centro Medico

La Plata, B1902, Argentina

Location

Instituto Medico CER

Quilmes, B1878DVB, Argentina

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Enroll SpA

Santiago, 7500587, Chile

Location

BioMedica Research Group Psicomedica Clinical and Research Group

Santiago, 7500710, Chile

Location

Clinica de la Costa S.A.S

Barranquilla, 080020, Colombia

Location

Centro de Investigacion Medico Asistencial S.A.S

Barranquilla, 80020, Colombia

Location

Healthy Medical Center

Zipaquirá, 250252, Colombia

Location

Polyclinic Bonifarm

Zagreb, 10000, Croatia

Location

Solmed Polyclinic

Zagreb, 10000, Croatia

Location

Revmatologicky Ustav

Prague, 12850, Czechia

Location

CHU de Nice Hôpital Pasteur 2 Centre de Réf des Maladies Neuromusculaires et SLA

Nice, 06001, France

Location

Groupe Hospitalier Pitie-Salpetriere service de médecine interne et immunologie cliniqu

Paris, 75651, France

Location

CHU Strasbourg - Hôpital Hautepierre service de rhumatologie

Strasbourg, 67091, France

Location

Charité - Campus Charité Mitte - Klinik für Dermatologie, Venerologie und Allergologie

Berlin, 10117, Germany

Location

Helios Fachklinik Vogelsang-Gommern

Gommern, 39245, Germany

Location

Universitätsklinikum Tübingen - Universitäts-Hautklinik

Tübingen, 72076, Germany

Location

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Medicina Interna

Brescia, 25123, Italy

Location

Azienda Ospedaliero Universitaria Policlinico. PO San Marco

Catania, 95100, Italy

Location

Ospedale San Raffaele U.O. di Medicina Gen. Ind. Immunologico-Clinica

Milan, 20132, Italy

Location

Azienda Ospedaliero Universitaria Pisana U.O. Reumatologia Universitaria

Pisa, 56100, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

Istituto Clinico Humanitas U.O. Reumatologia

Rozzano, 20089, Italy

Location

Ospedale San Giovanni Bosco

Torino, 10154, Italy

Location

Medical Care & Research SA de CV

Mérida, 97070, Mexico

Location

Centro de Investigacion Clínica GRAMEL S.C

México, 03720, Mexico

Location

Consultorio de Reumatologia Hospital Angeles Lindavista

México, 07760, Mexico

Location

Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.

San Luis Potosí City, 78213, Mexico

Location

Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty

Bialystok, 15-707, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Zespol Poradni Specjalistycznych Reumed

Lublin, 20-582, Poland

Location

Klinika Ambroziak ESTEDERM

Warsaw, 02-953, Poland

Location

Spitalul Clinic Colentina parent

Bucharest, 020125, Romania

Location

Spitalul Clinic 'Sf. Maria' Clinica de Medicina Interna si Reumatologie

Bucharest, 11172, Romania

Location

Sc Medaudio-Optica SRL

Râmnicu Vâlcea, 240762, Romania

Location

Hospital Universitari Vall d'Hebron Internal Medicine Dept.

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona Servicio de Medicina Interna

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge Servicio de Cardiologia

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

St. Peter´s Hospital Dept of Rheumatology

Chertsey, KT16 OPZ, United Kingdom

Location

Western General Hospital Dept of Rheumatology

Edinburgh, EH4 2XU, United Kingdom

Location

King's College Hospital Dept of Rheumatology

London, SE5 9RS, United Kingdom

Location

Salford Care Organisation Dept of Rheumatology

Salford, M6 8HD, United Kingdom

Location

Related Publications (1)

• Mammoliti O, Martina S, Claes P, Coti G, Blanque R, Jagerschmidt C, Shoji K, Borgonovi M, De Vos S, Marsais F, Oste L, Quinton E, Lopez-Ramos M, Amantini D, Brys R, Jimenez JM, Galien R, van der Plas S. Discovery of GLPG3667, a Selective ATP Competitive Tyrosine Kinase 2 Inhibitor for the Treatment of Autoimmune Diseases. J Med Chem. 2024 Jun 13;67(11):8545-8568. doi: 10.1021/acs.jmedchem.4c00769. Epub 2024 May 28.

  PMID: 38805213 DERIVED

MeSH Terms

Conditions

Dermatomyositis

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: February 27, 2023
• Primary Completion: October 13, 2025
• Study Completion: April 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7); CR (2); US (8); CL (2); FR (3); AR (5); CO (3); DE (3); BE (1); ES (4); RO (3); CZ (1); ME (4); GB (4); PL (4)