A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults W… (NCT05695950) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis
United States40 participantsStarted 2023-02-27
Plain-language summary
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), followed by an open-label extension (OLE) period until Week 48.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 G…
What they're measuring
1
Total improvement score [TIS] according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria