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

Sponsor
Amgen
Study ID
NCT03774875
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Apremilast 30 mg tablets taken orally twice a day.
  • Placebo — DRUG
    Placebo tablets taken orally twice a day

Study Details

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.

Key Dates

First listed
Dec 13, 2018
Start date
Mar 28, 2019
Status verified
Jul 2025
Primary completion
Feb 1, 2021
Completion
Nov 3, 2021

Study Design

Enrollment
277 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast 30 mg
    Participants will take apremilast 30 mg tablets orally twice a day for up to 52 weeks.
  • Placebo Comparator: Placebo / Apremilast 30 mg
    Participants will take placebo tablets orally twice a day for 16 weeks. After week 16, participants will be switched to receive apremilast 30 mg twice daily until Week 52.

Primary Outcome Measure

Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Baseline and week 16 ]

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