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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - 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.
  • - 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. Key

Exclusion Criteria:

  • - 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 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05695950
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Galapagos NV
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Galapagos Study Director
Principal Investigator Affiliation Galapagos NV
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Belgium, Bulgaria, Chile, Colombia, Croatia, Czechia, France, Italy, Poland, Romania, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dermatomyositis
Arms & Interventions

Arms

Experimental: GLPG3667

Participants will receive GLPG3667 dose A orally once daily for 24 weeks.

Placebo Comparator: Placebo

Participants will receive placebo matching to GLPG3667 orally once daily for 24 weeks.

Interventions

Drug: - GLPG3667

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

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

HonorHealth Neurology, Scottsdale, Arizona

Status

Recruiting

Address

HonorHealth Neurology

Scottsdale, Arizona, 85251

Upland, California

Status

Recruiting

Address

Inland Rheumatology Clinical Trials, Inc.

Upland, California, 91786

Omega Research Consultants, DeBary, Florida

Status

Recruiting

Address

Omega Research Consultants

DeBary, Florida, 32713

New Access Research and Medical Center, Kendall, Florida

Status

Recruiting

Address

New Access Research and Medical Center

Kendall, Florida, 33186

Augusta University, Augusta, Georgia

Status

Recruiting

Address

Augusta University

Augusta, Georgia, 30912

St. Paul Rheumatology, Saint Paul, Minnesota

Status

Recruiting

Address

St. Paul Rheumatology

Saint Paul, Minnesota, 55104

Northwell Health, LLC PRIME, Great Neck, New York

Status

Recruiting

Address

Northwell Health, LLC PRIME

Great Neck, New York, 11021

Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center for Clinical Research, P.C.

Duncansville, Pennsylvania, 16635

Arthritis & Osteoporosis Clinic, Waco, Texas

Status

Recruiting

Address

Arthritis & Osteoporosis Clinic

Waco, Texas, 76710

International Sites

Hospital Cordoba, Cordoba, Argentina

Status

Recruiting

Address

Hospital Cordoba

Cordoba, , X5004CDT

Hospital Italiano de La Plata, La Plata, Argentina

Status

Recruiting

Address

Hospital Italiano de La Plata

La Plata, , B1900

Centro Medico Framingham, La Plata, Argentina

Status

Recruiting

Address

Centro Medico Framingham

La Plata, , B1902

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

DCC Focus 5 - MEOH OOD, Sofia, Bulgaria

Status

Recruiting

Address

DCC Focus 5 - MEOH OOD

Sofia, , 1463

Enroll SpA, Santiago, Chile

Status

Recruiting

Address

Enroll SpA

Santiago, , 7500588

BioMedica Research Group, Santiago, Chile

Status

Recruiting

Address

BioMedica Research Group

Santiago, , 7500710

Clinical Research Chile SpA., Valdivia, Chile

Status

Recruiting

Address

Clinical Research Chile SpA.

Valdivia, , 5090000

Barranquilla, Colombia

Status

Recruiting

Address

Centro de Investigacion Medico Asistencial S.A.S

Barranquilla, , 80020

Floridablanca, Colombia

Status

Recruiting

Address

Fundacion Cardiovascular de Colombia - Instituto del Corazon

Floridablanca, , 681004

Healthy Medical Center, Zipaquirá, Colombia

Status

Recruiting

Address

Healthy Medical Center

Zipaquirá, , 250252

Polyclinic Bonifarm, Zagreb, Croatia

Status

Recruiting

Address

Polyclinic Bonifarm

Zagreb, , 10000

Solmed Polyclinic, Zagreb, Croatia

Status

Recruiting

Address

Solmed Polyclinic

Zagreb, , 10000

Revmatologicky Ustav, Praha 2, Czechia

Status

Recruiting

Address

Revmatologicky Ustav

Praha 2, , 12850

CHU de Nice Hôpital Pasteur 2, Nice, France

Status

Recruiting

Address

CHU de Nice Hôpital Pasteur 2

Nice, , 6001

Groupe Hospitalier Pitie-Salpetriere, Paris cedex 13, France

Status

Recruiting

Address

Groupe Hospitalier Pitie-Salpetriere

Paris cedex 13, , 75651

CHU Strasbourg - Hôpital Hautepierre, Strasbourg cedex, France

Status

Recruiting

Address

CHU Strasbourg - Hôpital Hautepierre

Strasbourg cedex, , 67091

Brescia, Italy

Status

Recruiting

Address

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

Brescia, , 25123

Catania, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Policlinico. PO San Marco

Catania, , 95121

Milano, Italy

Status

Recruiting

Address

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milano, , 20122

Milano, Italy

Status

Recruiting

Address

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

Milano, , 20132

Pisa, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Pisana U.O. Reumatologia Universitaria

Pisa, , 56100

Roma, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , 00168

Rozzano, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas U.O. Reumatologia

Rozzano, , 20089

Nova Reuma Spolka Partnerska, Bialystok, Poland

Status

Recruiting

Address

Nova Reuma Spolka Partnerska

Bialystok, , 15-707

Centrum Medyczne Plejady, Krakow, Poland

Status

Recruiting

Address

Centrum Medyczne Plejady

Krakow, , 30-363

Zespol Poradni Specjalistycznych Reumed, Lublin, Poland

Status

Recruiting

Address

Zespol Poradni Specjalistycznych Reumed

Lublin, , 20-607

Klinika Ambroziak ESTEDERM, Warsawa, Poland

Status

Recruiting

Address

Klinika Ambroziak ESTEDERM

Warsawa, , 02-953

Spitalul Clinic "Sf. Maria", Bucharest, Romania

Status

Recruiting

Address

Spitalul Clinic "Sf. Maria"

Bucharest, , 11172

Spitalul Clinic Colentina, Bucuresti, Romania

Status

Recruiting

Address

Spitalul Clinic Colentina

Bucuresti, , 20215

Sc Medaudio-Optica SRL, Râmnicu Vâlcea, Romania

Status

Recruiting

Address

Sc Medaudio-Optica SRL

Râmnicu Vâlcea, , 240762

Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona Servicio de Medicina Interna

Barcelona, , 08036

Hospital Universitari de Bellvitge, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari de Bellvitge

Barcelona, , 08907

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, , 8035

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , 28040

St. Peter´s hospital, Chertsey, United Kingdom

Status

Recruiting

Address

St. Peter´s hospital

Chertsey, , KT16 OPZ

London, United Kingdom

Status

Recruiting

Address

King's College Hospital Dept of Rheumatology

London, , SE5 9RS

Site Contact

King's College Hospital CT.gov contact

[email protected]

+3215342900

Salford Care Organisation, Salford, United Kingdom

Status

Recruiting

Address

Salford Care Organisation

Salford, , M6 8HD