A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Brief description: This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp.
Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.
Detailed 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 receive treatment with one of the following: 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 who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32. Observational Follow-up Phase Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early.
Detailed 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 receive treatment with one of the following: 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 who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32. Observational Follow-up Phase Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early.