A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)

Sponsor
Amgen
Study ID
NCT06122649
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • apremilast — DRUG
    Oral tablet
  • Placebo — DRUG
    Oral tablet

Study Details

The study aims to evaluate the clinical efficacy of oral apremilast 30 mg BID compared with placebo in Chinese participants with moderate to severe PsO

Key Dates

First listed
Nov 8, 2023
Start date
Nov 27, 2023
Status verified
Dec 2025
Primary completion
Feb 28, 2025
Completion
Dec 5, 2025

Study Design

Enrollment
203 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo-controlled Treatment Phas
    Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks.
  • Experimental: Active Treatment Phase
    Participants who received placebo during the placebo-controlled treatment phase will receive apremilast BID for 36 weeks. Participants who took apremilast will continue receiving it BID for 36 weeks.

Primary Outcome Measure

Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Week 16 ]

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