NCT03123471

A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast 30 mg tablets BID from weeks 0 to 32.
OTHER	Placebo	Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.

Timeline

• Start date: 2017-05-16
• Primary completion: 2018-08-13
• Completion: 2019-01-09
• First posted: 2017-04-21
• Last updated: 2020-05-13
• Results posted: 2019-09-04

Locations

45 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study