Biomedica Research Group | Santiago, Chile
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About
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).
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Inclusion and 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):
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:
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:
Primary purpose
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62 participants in 2 patient groups, including a placebo group
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Galapagos Medical Information
Data sourced from clinicaltrials.gov
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