Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04781816 | Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus | PHASE2 | COMPLETED | 78 | — | — | Apr 1, 2021 | Jun 26, 2023 | Aug 27, 2025 | 50 | United States, Argentina +13 |
The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. Baseline was defined as the Day 1 assessment value.
| Arm | Type | Description |
|---|---|---|
| SAR443122 | EXPERIMENTAL | SAR443122 for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| SAR443122 | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
| Placebo | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
Inclusion criteria : * Participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before Screening. * Participants with histologically confirmed and documented diagnosis within o...