An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 332
Summary
- Conditions
- Psoriasis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study will consist of four phases: Screening Phase - up to 35 days Double-blind Placebo-controlled Phase - Weeks 0 to 16 - Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID. Apremil...
The study will consist of four phases: Screening Phase - up to 35 days Double-blind Placebo-controlled Phase - Weeks 0 to 16 - Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID. Apremilast Extension Phase - Weeks 16 to 32 - All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32. Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
Tracking Information
- NCT #
- NCT03777436
- Collaborators
- Not Provided
- Investigators
- Study Director: MD Amgen
Get Well Soon