Phase 3
Completed N=176
Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
Source: ClinicalTrials.gov NCT05174065 ↗Enrolled (actual)
176
Serious AEs
3.1%
Results posted
Apr 2025
Primary outcomePrimary: 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 — 35.3; 67.8 percentage of participants — p=<0.0001
◆ Published Evidence
Emerging
5citations · ~5 / year
Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial.
Summary
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).
Linked Publications
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Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
35.3; 67.8 | <0.0001 sig |
| SECONDARY Change From Baseline in PPPASI Total Score at Week 16 |
-5.98; -12.12 | <0.0001 sig |
| SECONDARY Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16 |
-1.9; -3.4 | <0.0001 sig |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16 |
-9.9; -17.6 | 0.0330 sig |
| SECONDARY Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16 |
-7.5; -18.3 | 0.0076 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 |
-0.8; -2.3 | 0.0036 sig |
| SECONDARY Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) |
43; 63; 148; 1; 1; 9 | — |
Eligibility Criteria
- Key Inclusion Criteria
- Japanese participants ≥ 18 years of age upon entry into initial screening
- Palmoplantar pustulosis diagnosis with or without pustulotic arthro-osteitis (PAO) for no less than 24 weeks
- PPPASI total score of ≥12 at screening and at baseline
- Moderate or severe pustules/vesicles on palms or soles (PPPASI severity score ≥2) at screening and at baseline
- Inadequate response (defined as repeated relapsing-remitting in the same location for a 24-week period) to topical treatments prior to or at screening
- Key Exclusion Criteria
- Changes in disease severity during screening (PPPASI total score change ≥ 5 improvement, from screening to baseline)
- Periodontitis requiring treatment
- Chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment
- Has a diagnosis of plaque-type psoriasis at baseline
- Has the presence of pustular psoriasis on any part of the body other than the palms and soles
- Has evidence of skin conditions of hand and feet at baseline that would interfere with evaluations of the effect of Investigational Product
- Has unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within 12 weeks prior to screening
- Malignancy or history of malignancy
- Participant has received any procedures for focal infection within 24 weeks of baseline
- Female participants who are breastfeeding or who plan to breastfeed while on study
- Female participants of childbearing potential with a positive pregnancy test
- Had prior treatment with apremilast
- Has a prior medical history of suicide attempt at any time in the participant's lifetime prior to signing of informed consent or randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing of informed consent
Data sourced from ClinicalTrials.gov (NCT05174065) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.