NCT03721172

Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 595 (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 designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis. Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg 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 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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast, oral, twice daily
OTHER	Placebo	Placebo, oral, twice daily

Timeline

• Start date: 2019-03-11
• Primary completion: 2020-03-06
• Completion: 2020-07-24
• First posted: 2018-10-26
• Last updated: 2024-05-29
• Results posted: 2021-05-17

Locations

64 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study