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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00606450 | Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis | PHASE2 | COMPLETED | 260 | — | — | Apr 1, 2006 | May 1, 2007 | Apr 24, 2020 | 31 | Canada, Czechia +1 |
| NCT00604682 | Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis | PHASE2 | COMPLETED | 19 | — | — | Jan 1, 2005 | Dec 1, 2005 | Apr 24, 2020 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| 20 mg Apremilast daily | EXPERIMENTAL | 20 mg of CC-10004 daily |
| 20mg Apremilast twice daily | EXPERIMENTAL | CC-10004 twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo arm |
| Administration of CC10004 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CC-10004 | DRUG | 20 mg CC-10004 taken 1 time per day for 12 weeks |
| Placebo | DRUG | matching placebo taken either 1 or 2 times per day for 12 weeks |
| CC10004 | DRUG | 2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted |
Inclusion Criteria: * Must understand and voluntarily sign and informed consent form * Must be in good health as judged by the investigator * Must be able to adhere to the study visit schedule and other protocol requirements * Must have greater than or equal to a 6 month history of moderate-to-seve...