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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01300208 | To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus | PHASE2 | COMPLETED | 48 | — | — | Oct 1, 2010 | Mar 1, 2013 | Jun 23, 2020 | 19 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | CC-11050 (50 milligrams twice per day and Placebo) |
| Cohort 2 | EXPERIMENTAL | CC-11050 (100 milligrams twice per day and Placebo) |
| Cohort 3 | EXPERIMENTAL | CC-11050 (200 milligrams twice per day and Placebo) |
| Name | Type | Description |
|---|---|---|
| CC-11050 | DRUG | Cohort 1: 50 milligrams twice per day for 4 weeks Cohort 2: 100 milligrams twice per day for 8 weeks Cohort 3: 200 milligrams twice per day for 12 week |
| Placebo | OTHER | - |
Key Inclusion Criteria: * Subjects with a clinical diagnosis of discoid lupus erythematosus or sub acute lupus erythematosus for \> 16 weeks prior to screening and consistent histological findings on skin biopsy based on Gilliam classification who are candidates for systemic therapies (as determine...