Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-11050 · 2 trials · 2 indications
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria in Section 10.3), regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
| 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) |
| Administration of CC-11050 | EXPERIMENTAL | Part 1: Single Ascending Dose Part 2: drug-drug interaction/ food effect (DDI/FE) |
| 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 being studied for the treatment of cutaneous lupus erythematosus, including discoid lupus erythematosus and subacute cutaneous lupus erythematosus. It has also been evaluated in healthy volunteers for safety and pharmacokinetic studies. The drug is currently in Phase 2 clinical development.
CC-11050 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is an investigational small molecule in the immunology therapeutic area, currently in Phase 2 clinical development for cutaneous lupus erythematosus.
CC-11050 is in Phase 2 clinical development. One Phase 2 trial has been completed, evaluating the drug in subjects with discoid lupus erythematosus and subacute cutaneous lupus erythematosus. A Phase 1 study in healthy volunteers has also been completed. The drug is not approved and remains investigational.
CC-11050 has been studied in two completed clinical trials. NCT01300208 was a Phase 2 study in 48 subjects with cutaneous lupus erythematosus in the United States. NCT04139226 was a Phase 1 study in 44 healthy volunteers, evaluating a spray dried dispersion formulation under fed and fasted conditions and with omeprazole.
CC-11050 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for cutaneous lupus erythematosus. Clinical trials have been completed, but the drug has not received regulatory approval for any indication.