NCT03774875

A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life

A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the impact of treatment with apremilast 30 mg twice daily for 16 weeks, compared to placebo, on health-related quality of life (QOL) in adults with manifestations of plaque psoriasis and impaired quality of life.

Detailed description

Participants will be randomized 2 (apremilast):1 (placebo) in approximately 10 countries in Western Europe. Participants will be block-randomized to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations). Participants presenting with multiple manifestations will be allocated to the manifestation which is most severe, as determined by the participant. All manifestations will be assessed for efficacy at each study visit. The study will consist of 4 phases: * Screening Phase - up to 5 weeks (35 days) * Double-blind Placebo-controlled Phase - Weeks 0 to 16 Participants will receive treatment with either apremilast or matched placebo. * Apremilast Extension Phase - Weeks 16 through 52 All participants will be switched to (or continue with) apremilast at week 16 and will maintain this dosing through week 52. * Post-treatment Observational Follow-up Phase 4-week post-treatment observational follow-up phase for all participants who complete the study on treatment or discontinue from the study treatment early.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast 30 mg tablets taken orally twice a day.
DRUG	Placebo	Placebo tablets taken orally twice a day

Timeline

• Start date: 2019-03-28
• Primary completion: 2021-02-01
• Completion: 2021-11-03
• First posted: 2018-12-13
• Last updated: 2025-07-10
• Results posted: 2022-01-13

Locations

72 sites across 6 countries: France, Germany, Italy, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study