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

Psoriasis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Psoriasis

• NCT number: NCT03123471
• Study type: Interventional
• Source: Amgen
• Status: Completed
• Phase: Phase 3
• Start date: May 16, 2017
• Completion date: January 9, 2019