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Apremilast in Japanese Subjects With Palmoplantar Pustulosis
NCT05174065Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2022
- Primary completion
- Aug 2023
- Countries
- 1
- Sponsor
- Amgen
- Modality
- Small Molecules
- Drugs
- apremilast
- Conditions
- palmoplantar pustulosis (PPP)
01
Overview
Phase 3, randomised, double-blind trial in palmoplantar pustulosis (PPP) comparing Apremilast with Placebo -> Apremilast (2 arms). Primary endpoint: Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in Palmoplantar Pustulosis Area and Severity Index Total Score at 16 weeks. Started Mar 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Apremilast
Apremilast BID for 52 weeks
Placebo -> Apremilast
Placebo BID for 16 weeks, then Apremilast BID for 36 weeks
03
Who it enrols
Japanese adults with moderate to severe palmoplantar pustulosis (PPPASI >= 12, severity >= 2) and inadequate response to topical treatments.
04
Endpoints
Primary
Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in Palmoplantar Pustulosis Area and Severity Index Total Score
Secondary
Change From Baseline in PPPASI Total Score
Change From Baseline in Palmoplantar Pustulosis Severity Index Total Score
Change From Baseline in Visual Analogue Scale Assessment for PPP Symptoms (Pruritus)
Change From Baseline in Visual Analogue Scale Assessment for PPP Symptoms (Pain/Discomfort)
Change From Baseline in Dermatology Life Quality Index Total Score
Number of Participants Who Experienced a Treatment-emergent Adverse Event
05
Results
Primary endpoints met
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