Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

Sponsor
Amgen
Study ID
NCT05174065
Phase
PHASE3
Status
Completed

Conditions

  • Palmoplantar Pustulosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Oral tablets
  • Placebo — DRUG
    Oral tablets

Study Details

The primary objective of the study is to evaluate the efficacy of apremilast (AMG 407) twice daily (BID) compared with placebo in participants with Palmoplantar Pustulosis (PPP).

Key Dates

First listed
Dec 30, 2021
Start date
Mar 8, 2022
Status verified
Feb 2025
Primary completion
Aug 19, 2023
Completion
Jun 1, 2024

Study Design

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

Arms

  • Experimental: Apremilast
    Apremilast will be administered to participants twice daily (BID)
  • Experimental: Placebo and Apremilast
    Matching placebo will be administered to participants twice daily (BID) until week 16. After week 16, Apremilast will be administered to participants BID.

Primary Outcome Measure

Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score (PPPASI-50) at Week 16 [ Time Frame: Baseline and Week 16 ]

Related Studies