A study evaluating the effects of GLPG3667 given as oral treatment for up to 24 weeks in adults with dermatomyositis

You may be able to join if

• Female or male subjects from 18 to 75 years of age inclusive, on the date of signing the informed consent form.
• Subject has probable or definite DM in accordance with the ACR/EULAR criteria for at least 3 months.
• Subject with dermatomyositis 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.
• Subject must present objective evidence of active disease as defined by fulfilling 1 of the criteria below (as confirmed by the sponsor): dermatomyositis rash as defined by m-CDASI-A >= 6 at screening, or creatinine kinase > 4x ULN at screening, or muscle biopsy evidence of active disease within 3 months prior to screening (as 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.
• Subject 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 and/or Patient’s Global Disease Activity score > 2/10 cm on the visual analog scale (VAS), and/or extra-muscular disease activity > 2/10 cm on VAS, and/or Health Assessment Questionnaire-Disability Index score > 0.25, and/or elevated muscle enzymes (e.g. aldolase, CK, ALT, AST, and lactate dehydrogenase) with at least 1 muscle enzyme > 1.5x ULN.
• Subject previously demonstrated failure to or intolerance to first-line treatment (defined as oral corticosteroid[s] and at least 1 immunosuppressant/hydroxychloroquine) OR active disease despite treatment with first-line drugs. Currently, the subject is receiving maximum 3 treatments for dermatomyositis (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 protocol.