At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of palmoplantar pustulosis (with or without pustulotic arthro-osteitis) for at least 24 weeks before screening
- ✓PPPASI total score ≥12 at screening and baseline
- ✓Moderate or severe pustules/vesicles on palms or soles (PPPASI severity score ≥2)
- ✓Inadequate response to prior topical steroid and/or topical vitamin D3 derivative treatment
- ✕Diagnosis of plaque-type psoriasis
- ✕Pustular psoriasis in any body part other than palms and soles
- ✕Obvious improvement during screening (≥5 point PPPASI total score improvement)
- ✕Procedures for focal infection (e.g., tonsillectomy, dental therapy) within 24 weeks of baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Apremilast and Placebo for Palmoplantaris Pustulosis. Completed, enrolled 90 participants across 22 sites.
Detailed 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.
Study Details
Timeline
Interventions
Apremilast
Placebo