Last updated 4 days ago
A Study Evaluating the Effects of GLPG3667 Given As Oral Treatment for Up to 24 Weeks in Adults with Dermatomyositis
62 patients around the world
Available in Chile, Argentina, Colombia
Galapagos NV
8Research sites
62Patients around the world
This study is for people with
Inflammatory Myopathies
Dermatomyositis
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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, orCreatine kinase (CK) > 4x upper limit of normal (ULN) at screening, ormuscle biopsy evidence of active disease within 3 months prior to screening (defined as presence of active inflammation in muscle biopsy), ormuscle magnetic resonance imaging showing active inflammation (edema) of the proximal skeletal muscles within 3 months prior to screening, orelectromyography showing acute changes, such as spontaneous activity and myopathic changes not explained by other diseases within 3 months prior to screening, orany 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 2 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.
- 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.
Sites
Hospital Córdoba
Recruiting
Centro Médico Framingham
Recruiting
Hospital Italiano de La Plata
Recruiting
Clinical Research Chile SpA
Recruiting
Biomedica Research Group
Recruiting
Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S.
Recruiting
Healthy Medical Center
Recruiting
Fundación Cardiovascular de Colombia
Recruiting
StudyGALARISSO
SponsorGalapagos NV
Conditions
Dermatomyositis
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05695950
