A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis
NCT ID: NCT05695950
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-02-27
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GLPG3667 During DB + During OLE
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.
GLPG3667
GLPG3667 capsules will be administered per dose and schedule specified in the arm description.
Placebo During DB + GLPG3667 During OLE
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.
GLPG3667
GLPG3667 capsules will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to GLPG3667 capsules will be administered per schedule specified in the arm description.
Interventions
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GLPG3667
GLPG3667 capsules will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to GLPG3667 capsules will be administered per schedule specified in the arm description.
Eligibility Criteria
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Inclusion Criteria
* 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.
* Participant previously demonstrated failure to or intolerance to first-line treatment (defined as oral corticosteroid\[s\] and at least 1 other immunosuppressant/ hydroxychloroquine) OR active disease despite treatment with first-line drugs. Currently, the participant is receiving maximum 3 treatments for DM (oral corticosteroid\[s\] and/or allowed immunosuppressant\[s\]/hydroxychloroquine) for at least 3 months and is on a stable dose (defined as no change in dose, type of administration, or dose regimen) for at least 4 weeks prior to screening and during screening within maximum allowed doses as specified in the study protocol. Note: Participants receiving 1 or no concomitant treatment for DM are also eligible.
Exclusion Criteria
* Participant has other causes of myositis (e.g. connective tissue disease) associated DM, polymyositis, juvenile DM, inclusion body myositis, or necrotizing idiopathic inflammatory myopathies (with or without rash) with the exception of overlap with secondary Sjogren's syndrome.
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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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
Hospital Italiano de La Plata
La Plata, , Argentina
Framingham Centro Medico
La Plata, , Argentina
Instituto Medico CER
Quilmes, , Argentina
UZ Leuven
Leuven, , Belgium
Enroll SpA
Santiago, , Chile
BioMedica Research Group Psicomedica Clinical and Research Group
Santiago, , Chile
Clinica de la Costa S.A.S
Barranquilla, , Colombia
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, , Colombia
Healthy Medical Center
Zipaquirá, , Colombia
Polyclinic Bonifarm
Zagreb, , Croatia
Solmed Polyclinic
Zagreb, , Croatia
Revmatologicky Ustav
Prague, , Czechia
CHU de Nice Hôpital Pasteur 2 Centre de Réf des Maladies Neuromusculaires et SLA
Nice, , France
Groupe Hospitalier Pitie-Salpetriere service de médecine interne et immunologie cliniqu
Paris, , France
CHU Strasbourg - Hôpital Hautepierre service de rhumatologie
Strasbourg, , France
Charité - Campus Charité Mitte - Klinik für Dermatologie, Venerologie und Allergologie
Berlin, , Germany
Helios Fachklinik Vogelsang-Gommern
Gommern, , Germany
Universitätsklinikum Tübingen - Universitäts-Hautklinik
Tübingen, , Germany
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Medicina Interna
Brescia, , Italy
Azienda Ospedaliero Universitaria Policlinico. PO San Marco
Catania, , Italy
Ospedale San Raffaele U.O. di Medicina Gen. Ind. Immunologico-Clinica
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana U.O. Reumatologia Universitaria
Pisa, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Istituto Clinico Humanitas U.O. Reumatologia
Rozzano, , Italy
Ospedale San Giovanni Bosco
Torino, , Italy
Medical Care & Research SA de CV
Mérida, , Mexico
Centro de Investigacion Clínica GRAMEL S.C
México, , Mexico
Consultorio de Reumatologia Hospital Angeles Lindavista
México, , Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
San Luis Potosí City, , Mexico
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Zespol Poradni Specjalistycznych Reumed
Lublin, , Poland
Klinika Ambroziak ESTEDERM
Warsaw, , Poland
Spitalul Clinic Colentina parent
Bucharest, , Romania
Spitalul Clinic 'Sf. Maria' Clinica de Medicina Interna si Reumatologie
Bucharest, , Romania
Sc Medaudio-Optica SRL
Râmnicu Vâlcea, , Romania
Hospital Universitari Vall d'Hebron Internal Medicine Dept.
Barcelona, , Spain
Hospital Clinic de Barcelona Servicio de Medicina Interna
Barcelona, , Spain
Hospital Universitari de Bellvitge Servicio de Cardiologia
L'Hospitalet de Llobregat, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
St. Peter´s Hospital Dept of Rheumatology
Chertsey, , United Kingdom
Western General Hospital Dept of Rheumatology
Edinburgh, , United Kingdom
King's College Hospital Dept of Rheumatology
London, , United Kingdom
Salford Care Organisation Dept of Rheumatology
Salford, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2022-501097-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
GLPG3667-CL-214
Identifier Type: -
Identifier Source: org_study_id