A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
Status:
Completed
Trial end date:
2021-06-07
Target enrollment:
Participant gender:
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.