Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Conditions
Interventions
The following dosing regimens are proposed to be investigated in Cohort A over a treatment duration of at least 24 weeks: 25, 50 and 100 mg enpatoran twice per day administered orally in a tablet form
Sponsors
Ishii Kyoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort A will have participants with CLE (active SCLE, and/or DLE) (CLASI-A => 8) or SLE with predominantly active lupus rash (CLASI-A => 8) Cohort B will have SLE participants who have moderate to high systemic disease activity (BILAG => 1A and/or 2B) with 1 or 2 of the following: CLASI A => 8 and/or SLEDAI => 6.
Exclusion criteria
Exclusion criteria: 1. Primary diagnosis of autoimmune or rheumatic disease other than SLE or CLE (discuss with Medical Monitor if overlap syndrome). Note: Secondary Sjogren's syndrome or an autoimmune thyroiditis are not exclusionary. 2. Drug-induced lupus (SLE or CLE). 3. Any condition including dermatological diseases other than cutaneous manifestations of SLE or CLE (e.g., psoriasis), or any uncontrolled disease (e.g., asthma, interstitial lung disease, pulmonary arterial hypertension, morbid obesity), that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dose-response relationship of enpatoran in reducing disease activity based on CLASI-A To evaluate the dose-response relationship of enpatoran in reducing disease activity based on BICLA response rate | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Greece, Israel, Japan, Mauritius, Mexico, Moldova, Philippines, Poland, Puerto Rico, Russia, Serbia, South Africa, Spain, Sweden, Ukrine, United States
Contacts
Public ContactClinical Trial Information Contact
Merck Biopharma Co., Ltd.
Outcome results
None listed