Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-11050 · 1 trial · 1 indication
| 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...
CC-11050 is an investigational small molecule developed by Amgen Inc. (ticker AMGN) for cutaneous lupus erythematosus, an immunology condition affecting the skin. It has been studied in a Phase 2 clinical trial in adults with discoid lupus erythematosus and subacute cutaneous lupus erythematosus. CC-11050 has not been approved by the FDA and remains in clinical development.
CC-11050 is being developed for cutaneous lupus erythematosus, including the discoid lupus erythematosus and subacute cutaneous lupus erythematosus subtypes. The Phase 2 study enrolled adults 18 years and older with these skin manifestations of lupus. No approved indication for CC-11050 has been established.
CC-11050 is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor of the Phase 2 clinical program evaluating CC-11050 in cutaneous lupus erythematosus. The compound is an investigational small molecule in the company's immunology pipeline.
CC-11050 is in Phase 2 development. Its single registered trial, NCT01300208, was a Phase 2 study in cutaneous lupus erythematosus that has been completed. CC-11050 is not FDA approved and remains an investigational agent rather than an available treatment.
CC-11050 has been evaluated in one registered clinical trial, NCT01300208, titled to evaluate the preliminary safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CC-11050 in subjects with discoid lupus erythematosus and subacute cutaneous lupus erythematosus. The Phase 2 study enrolled 48 participants in the United States and is completed.
The CC-11050 Phase 2 trial NCT01300208 was a randomized, double-blind, controlled study in adults with discoid lupus erythematosus and subacute cutaneous lupus erythematosus. It enrolled 48 participants across sites in the United States, included both sexes, and did not enroll healthy volunteers. The study is completed.