A Study Evaluating the Effects of GLPG3667 Given As Oral Treatment for Up to 24 Weeks in Adults with Dermatomyositis

Last updated: March 10, 2025
Sponsor: Galapagos NV
Overall Status: Active - Recruiting

Phase

2

Condition

Connective Tissue Diseases

Lupus

Idiopathic Inflammatory Myopathies

Treatment

GLPG3667

Placebo

Clinical Study ID

NCT05695950
GLPG3667-CL-214
2022-501097-19-00
2022-501097-19
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participant has probable or definite DM in accordance with the ACR/EULAR criteriafor at least 3 months.

  • Participant with DM diagnosed in the 3 years prior to screening must have undergonecancer screening (according to local standard of care or applicable guidelines)within 1 year prior to screening. Note: The evidence of cancer screening must bedocumented.

  • Participant must present objective evidence of active disease as defined byfulfilling 1 of the criteria below (as confirmed by the sponsor):

  • DM rash as defined by modified-Cutaneous Dermatomyositis Disease Area andSeverity 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 theproximal skeletal muscles within 3 months prior to screening, or

  • electromyography showing acute changes, such as spontaneous activity andmyopathic changes not explained by other diseases within 3 months prior toscreening, or

  • any other clinical evidence of active disease as confirmed by the steeringcommittee.

  • 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 atscreening:

  • 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 lactatedehydrogenase) with at least 1 muscle enzyme > 1.5x ULN.

  • Participant previously demonstrated failure to or intolerance to first-linetreatment (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 (oralcorticosteroid[s] and/or allowed immunosuppressant[s]/hydroxychloroquine) for atleast 3 months and is on a stable dose (defined as no change in dose, type ofadministration, or dose regimen) for at least 4 weeks prior to screening and duringscreening within maximum allowed doses as specified in the study protocol. Note:Participants receiving 1 or no concomitant treatment for DM are also eligible.

  • Open Label Extension : Participant must meet both of the following inclusioncriteria at Visit 8 to be eligible for participation in the OLE period of the study:participant who may benefit from open-label treatment with GLPG3667, according tothe investigator's judgment; participant who completed the 24-week double-blindtreatment period on investigational product.

Exclusion

Key Exclusion Criteria:

  • Participant has cancer-associated myositis (defined as myositis diagnosed within 2years of cancer diagnosis with the exception of basal cell carcinoma, squamous cellcarcinoma of the skin, or in situ uterine cervical carcinoma that has been excisedand cured). Note: At least 1 year for basal cell carcinoma and squamous cellcarcinoma or 5 years for in situ uterine cervical carcinoma must have passed sincethe excision.

  • Participant has other causes of myositis (e.g. connective tissue disease) associatedDM, polymyositis, juvenile DM, inclusion body myositis, or necrotizing idiopathicinflammatory myopathies (with or without rash) with the exception of overlap withsecondary Sjogren's syndrome.

  • Participant has permanent muscle weakness due to muscle damage (e.g. participant iswheelchair bound or has significant muscle atrophy on magnetic resonance imaging [MRI]) or a non-DM cause (drug-induced myopathy, including glucocorticoid-inducedmyopathy as primary cause of muscle weakness), according to investigator'sjudgement.

  • Participant has taken any prohibited therapies within the defined washout periodsbefore screening, and during screening as listed in the study protocol.

  • Open Label Extension : Participant meeting one or more of the criteria at Visit 8 asdefined in the protocol, cannot be selected for the OLE period of this clinicalstudy. 1. Participant has total bilirubin >1.5x ULN; however, participant with anisolated increase in total bilirubin <3 x ULN due to Gilbert's Syndrome, with normaldirect 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 muscularorigin (and confirmed by the steering committee) at Visit 7 and Visit 8.

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: GLPG3667
Phase: 2
Study Start date:
February 27, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Fundacion Respirar Consultorios Médicos Dr. Doreski

    Ciudad Autonoma de Buenos Aires, C1426ABO
    Argentina

    Active - Recruiting

  • Hospital Cordoba

    Cordoba, X5004CDT
    Argentina

    Active - Recruiting

  • Centro Medico Framingham

    La Plata, B1902
    Argentina

    Active - Recruiting

  • Framingham Centro Medico

    La Plata, B1902
    Argentina

    Active - Recruiting

  • Hospital Italiano de La Plata

    La Plata, B1900
    Argentina

    Active - Recruiting

  • Instituto Medico CER

    Quilmes, B1878DVB
    Argentina

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • DCC Focus 5 - MEOH OOD

    Sofia, 1463
    Bulgaria

    Site Not Available

  • BioMedica Research Group

    Santiago, 7500710
    Chile

    Active - Recruiting

  • BioMedica Research Group Psicomedica Clinical and Research Group

    Santiago, 7500710
    Chile

    Active - Recruiting

  • Enroll SpA

    Santiago, 7500587
    Chile

    Active - Recruiting

  • Clinical Research Chile SpA.

    Valdivia, 5090000
    Chile

    Site Not Available

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, 80020
    Colombia

    Active - Recruiting

  • Clinica de la Costa S.A.S

    Barranquilla, 080020
    Colombia

    Active - Recruiting

  • Fundacion Cardiovascular de Colombia

    Floridablanca, 681004
    Colombia

    Site Not Available

  • Fundacion Cardiovascular de Colombia - Instituto del Corazon

    Floridablanca, 681004
    Colombia

    Site Not Available

  • Healthy Medical Center

    Zipaquirá, 250252
    Colombia

    Active - Recruiting

  • Polyclinic Bonifarm

    Zagreb, 10000
    Croatia

    Active - Recruiting

  • Solmed Polyclinic

    Zagreb, 10000
    Croatia

    Active - Recruiting

  • Revmatologicky Ustav

    Praha 2, 12850
    Czechia

    Active - Recruiting

  • CHU de Nice Hôpital Pasteur 2

    Nice, 6001
    France

    Site Not Available

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

    Nice, 06001
    France

    Active - Recruiting

  • Groupe Hospitalier Pitie-Salpetriere

    Paris cedex 13, 75651
    France

    Site Not Available

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

    Paris cedex 13, 75651
    France

    Active - Recruiting

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg cedex, 67091
    France

    Site Not Available

  • CHU Strasbourg - Hôpital Hautepierre service de rhumatologie

    Strasbourg cedex, 67091
    France

    Active - Recruiting

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

    Berlin, 10117
    Germany

    Active - Recruiting

  • Helios Fachklinik Vogelsang-Gommern

    Gommern, 39245
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen - Universitäts-Hautklinik

    Tübingen, 72076
    Germany

    Active - Recruiting

  • Helios Fachklinik Vogelsang-Gommern

    Vogelsang-Gommern, 39245
    Germany

    Site Not Available

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

    Brescia, 25123
    Italy

    Active - Recruiting

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

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Policlinico. PO San Marco

    Catania, 95100
    Italy

    Active - Recruiting

  • Ospedale San Marco

    Catania, 95123
    Italy

    Active - Recruiting

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

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

    Milano, 20132
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana U.O. Reumatologia Universitaria

    Pisa, 56100
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas U.O. Reumatologia

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Ospedale San Giovanni Bosco

    Torino, 10154
    Italy

    Active - Recruiting

  • Consultorio de Reumatologia Hospital Angeles Lindavista

    Ciudad de México, 07760 CDMX
    Mexico

    Site Not Available

  • Centro de Investigacion Clínica GRAMEL S.C

    Mexico, 03720
    Mexico

    Active - Recruiting

  • Consultorio de Reumatologia Hospital Angeles Lindavista

    Mexico, 07760
    Mexico

    Active - Recruiting

  • Medical Care & Research SA de CV

    Mérida, 97070
    Mexico

    Active - Recruiting

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

    San Luis Potosi, 78213
    Mexico

    Active - Recruiting

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

    Bialystok, 15-707
    Poland

    Active - Recruiting

  • Nova Reuma Spolka Partnerska

    Bialystok, 15-707
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, 30-363
    Poland

    Active - Recruiting

  • Zespol Poradni Specjalistycznych Reumed

    Lublin, 20-582
    Poland

    Active - Recruiting

  • Klinika Ambroziak ESTEDERM

    Warsawa, 02-953
    Poland

    Active - Recruiting

  • Spitalul Clinic "Sf. Maria"

    Bucharest, 11172
    Romania

    Site Not Available

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

    Bucharest, 11172
    Romania

    Active - Recruiting

  • Spitalul Clinic Colentina

    Bucuresti, 20215
    Romania

    Site Not Available

  • Spitalul Clinic Colentina parent

    Bucuresti, 020125
    Romania

    Active - Recruiting

  • Sc Medaudio-Optica SRL

    Râmnicu Vâlcea, 240762
    Romania

    Active - Recruiting

  • Hospital Clinic de Barcelona Servicio de Medicina Interna

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron Internal Medicine Dept.

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona, 08907
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge Servicio de Cardiologia

    L'Hospitalet de Llobregat, 08907
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • St. Peter´s Hospital Dept of Rheumatology

    Chertsey, KT16 OPZ
    United Kingdom

    Active - Recruiting

  • St. Peter´s hospital

    Chertsey, KT16 OPZ
    United Kingdom

    Site Not Available

  • Western General Hospital Dept of Rheumatology

    Edinburgh, EH4 2XU
    United Kingdom

    Active - Recruiting

  • King's College Hospital Dept of Rheumatology

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Salford Care Organisation

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Salford Care Organisation Dept of Rheumatology

    Salford, M6 8HD
    United Kingdom

    Active - Recruiting

  • HonorHealth Neurology

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California 91786
    United States

    Active - Recruiting

  • Omega Research Consultants

    DeBary, Florida 32713
    United States

    Site Not Available

  • New Access Research and Medical Center

    Kendall, Florida 33186
    United States

    Active - Recruiting

  • Omega Research Orlando, LLC

    Orlando, Florida 32808
    United States

    Active - Recruiting

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • St. Paul Rheumatology

    Eagan, Minnesota 55121
    United States

    Active - Recruiting

  • St. Paul Rheumatology

    Saint Paul, Minnesota 55104
    United States

    Site Not Available

  • Northwell Health, LLC PRIME

    Great Neck, New York 11021
    United States

    Site Not Available

  • Northwell Health, LLC PRIME

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Altoona Center for Clinical Research, P.C.

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Arthritis & Osteoporosis Clinic

    Waco, Texas 76710
    United States

    Site Not Available

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