NCT04057937

A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Palmoplantar Pustulosis in Japan

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations. The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.

Conditions

• Palmoplantaris Pustulosis

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-10-16
• Primary completion: 2021-01-18
• Completion: 2021-06-07
• First posted: 2019-08-15
• Last updated: 2024-07-17
• Results posted: 2022-01-06

Locations

22 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study