Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Conditions
Brief summary
Percentage change from baseline in CLASI activity (CLASIA) score
Detailed description
Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI-50), Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline, Mean change from baseline in CLASI-A score, Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0", Number and proportion of participants experiencing SAEs, AEs (with severity and relationship of AEs), and abnormalities in laboratory testing, vital signs, and 12-lead ECGs
Interventions
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in CLASI activity (CLASIA) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI-50), Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline, Mean change from baseline in CLASI-A score, Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0", Number and proportion of participants experiencing SAEs, AEs (with severity and relationship of AEs), and abnormalities in laboratory testing, vital signs, and 12-lead ECGs | — |
Countries
France, Germany, Poland
Outcome results
None listed