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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01597050 | Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions | PHASE2 | COMPLETED | 54 | — | — | Aug 1, 2012 | Sep 1, 2013 | Jul 14, 2016 | 15 | United States, Canada |
Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions.
| Arm | Type | Description |
|---|---|---|
| Drug: R932333 | ACTIVE_COMPARATOR | R333 6% (60 mg/g), bid |
| Placebo | PLACEBO_COMPARATOR | Placebo, bid |
| Name | Type | Description |
|---|---|---|
| R932333 | DRUG | R393233 6% (60 mg/g), bid |
| Placebo | DRUG | Placebo, bid |
Inclusion Criteria: * Diagnosis of SLE or DLE (DLE confirmed histologically prior to randomization). * At least 2 active discoid lesions secondary to SLE or DLE prior to study entry, each with a minimum Erythema Rating Score of ≥ 2. At least 1 of the active discoid lesions must have been present (b...