Phase
Condition
Connective Tissue Diseases
Lupus
Idiopathic Inflammatory Myopathies
Treatment
GLPG3667
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Fundacion Respirar Consultorios Médicos Dr. Doreski
Ciudad Autonoma de Buenos Aires, C1426ABO
ArgentinaActive - Recruiting
Hospital Cordoba
Cordoba, X5004CDT
ArgentinaActive - Recruiting
Centro Medico Framingham
La Plata, B1902
ArgentinaActive - Recruiting
Framingham Centro Medico
La Plata, B1902
ArgentinaActive - Recruiting
Hospital Italiano de La Plata
La Plata, B1900
ArgentinaActive - Recruiting
Instituto Medico CER
Quilmes, B1878DVB
ArgentinaActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
DCC Focus 5 - MEOH OOD
Sofia, 1463
BulgariaSite Not Available
BioMedica Research Group
Santiago, 7500710
ChileActive - Recruiting
BioMedica Research Group Psicomedica Clinical and Research Group
Santiago, 7500710
ChileActive - Recruiting
Enroll SpA
Santiago, 7500587
ChileActive - Recruiting
Clinical Research Chile SpA.
Valdivia, 5090000
ChileSite Not Available
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, 80020
ColombiaActive - Recruiting
Clinica de la Costa S.A.S
Barranquilla, 080020
ColombiaActive - Recruiting
Fundacion Cardiovascular de Colombia
Floridablanca, 681004
ColombiaSite Not Available
Fundacion Cardiovascular de Colombia - Instituto del Corazon
Floridablanca, 681004
ColombiaSite Not Available
Healthy Medical Center
Zipaquirá, 250252
ColombiaActive - Recruiting
Polyclinic Bonifarm
Zagreb, 10000
CroatiaActive - Recruiting
Solmed Polyclinic
Zagreb, 10000
CroatiaActive - Recruiting
Revmatologicky Ustav
Praha 2, 12850
CzechiaActive - Recruiting
CHU de Nice Hôpital Pasteur 2
Nice, 6001
FranceSite Not Available
CHU de Nice Hôpital Pasteur 2 Centre de Réf des Maladies Neuromusculaires et SLA
Nice, 06001
FranceActive - Recruiting
Groupe Hospitalier Pitie-Salpetriere
Paris cedex 13, 75651
FranceSite Not Available
Groupe Hospitalier Pitie-Salpetriere service de médecine interne et immunologie cliniqu
Paris cedex 13, 75651
FranceActive - Recruiting
CHU Strasbourg - Hôpital Hautepierre
Strasbourg cedex, 67091
FranceSite Not Available
CHU Strasbourg - Hôpital Hautepierre service de rhumatologie
Strasbourg cedex, 67091
FranceActive - Recruiting
Charité - Campus Charité Mitte - Klinik für Dermatologie, Venerologie und Allergologie
Berlin, 10117
GermanyActive - Recruiting
Helios Fachklinik Vogelsang-Gommern
Gommern, 39245
GermanyActive - Recruiting
Universitätsklinikum Tübingen - Universitäts-Hautklinik
Tübingen, 72076
GermanyActive - Recruiting
Helios Fachklinik Vogelsang-Gommern
Vogelsang-Gommern, 39245
GermanySite Not Available
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Medicina Interna
Brescia, 25123
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Policlinico. PO San Marco
Catania, 95100
ItalyActive - Recruiting
Ospedale San Marco
Catania, 95123
ItalyActive - Recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
Ospedale San Raffaele U.O. di Medicina Gen. Ind. Immunologico-Clinica
Milano, 20132
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana U.O. Reumatologia Universitaria
Pisa, 56100
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
ItalyActive - Recruiting
Istituto Clinico Humanitas U.O. Reumatologia
Rozzano, 20089
ItalyActive - Recruiting
Ospedale San Giovanni Bosco
Torino, 10154
ItalyActive - Recruiting
Consultorio de Reumatologia Hospital Angeles Lindavista
Ciudad de México, 07760 CDMX
MexicoSite Not Available
Centro de Investigacion Clínica GRAMEL S.C
Mexico, 03720
MexicoActive - Recruiting
Consultorio de Reumatologia Hospital Angeles Lindavista
Mexico, 07760
MexicoActive - Recruiting
Medical Care & Research SA de CV
Mérida, 97070
MexicoActive - Recruiting
Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
San Luis Potosi, 78213
MexicoActive - Recruiting
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, 15-707
PolandActive - Recruiting
Nova Reuma Spolka Partnerska
Bialystok, 15-707
PolandSite Not Available
Centrum Medyczne Plejady
Krakow, 30-363
PolandActive - Recruiting
Zespol Poradni Specjalistycznych Reumed
Lublin, 20-582
PolandActive - Recruiting
Klinika Ambroziak ESTEDERM
Warsawa, 02-953
PolandActive - Recruiting
Spitalul Clinic "Sf. Maria"
Bucharest, 11172
RomaniaSite Not Available
Spitalul Clinic 'Sf. Maria' Clinica de Medicina Interna si Reumatologie
Bucharest, 11172
RomaniaActive - Recruiting
Spitalul Clinic Colentina
Bucuresti, 20215
RomaniaSite Not Available
Spitalul Clinic Colentina parent
Bucuresti, 020125
RomaniaActive - Recruiting
Sc Medaudio-Optica SRL
Râmnicu Vâlcea, 240762
RomaniaActive - Recruiting
Hospital Clinic de Barcelona Servicio de Medicina Interna
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 8035
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron Internal Medicine Dept.
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitari de Bellvitge
Barcelona, 08907
SpainActive - Recruiting
Hospital Universitari de Bellvitge Servicio de Cardiologia
L'Hospitalet de Llobregat, 08907
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
St. Peter´s Hospital Dept of Rheumatology
Chertsey, KT16 OPZ
United KingdomActive - Recruiting
St. Peter´s hospital
Chertsey, KT16 OPZ
United KingdomSite Not Available
Western General Hospital Dept of Rheumatology
Edinburgh, EH4 2XU
United KingdomActive - Recruiting
King's College Hospital Dept of Rheumatology
London, SE5 9RS
United KingdomActive - Recruiting
Salford Care Organisation
Salford, M6 8HD
United KingdomSite Not Available
Salford Care Organisation Dept of Rheumatology
Salford, M6 8HD
United KingdomActive - Recruiting
HonorHealth Neurology
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Inland Rheumatology Clinical Trials, Inc.
Upland, California 91786
United StatesActive - Recruiting
Omega Research Consultants
DeBary, Florida 32713
United StatesSite Not Available
New Access Research and Medical Center
Kendall, Florida 33186
United StatesActive - Recruiting
Omega Research Orlando, LLC
Orlando, Florida 32808
United StatesActive - Recruiting
Augusta University
Augusta, Georgia 30912
United StatesActive - Recruiting
St. Paul Rheumatology
Eagan, Minnesota 55121
United StatesActive - Recruiting
St. Paul Rheumatology
Saint Paul, Minnesota 55104
United StatesSite Not Available
Northwell Health, LLC PRIME
Great Neck, New York 11021
United StatesSite Not Available
Northwell Health, LLC PRIME
Lake Success, New York 11042
United StatesActive - Recruiting
Altoona Center for Clinical Research, P.C.
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Arthritis & Osteoporosis Clinic
Waco, Texas 76710
United StatesSite Not Available
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