Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Apremilast (AMG 407) in Japanese Subjects With Palmoplantar Pustulosis (PPP)

Conditions
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Palmoplantar Pustulosis

Intervention / Treatment
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* Drug: Apremilast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apremilast<br>Apremilast will be administered to participants twice daily (BID) | Drug: Apremilast<br>* Oral tablets<br>* Other names: AMG 407;|
| Experimental: Placebo and Apremilast<br>Matching placebo will be administered to participants twice daily (BID) until week 16. After week 16, Apremilast will be administered to participants BID. | Drug: Apremilast<br>* Oral tablets<br>* Other names: AMG 407;Drug: Placebo<br>* Oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants achieving at least 50% reduction from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score (PPPASI-50) at week 16 | PPPASI is a disease-specific efficacy assessment tool used by Investigators established to detect a change of disease status on palms or soles. PPPASI produces numeric scores that can range from 0 to 72. A higher score indicates more severe disease. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PPPASI total score at week 16 |  | 16 weeks | 
| Change from baseline in Palmoplantar Pustulosis Severity Index (PPSI) total score at week 16 | PPSI is a disease-specific efficacy assessment established to detect a change of disease status on a specified palm or sole. PPSI produces numeric scores that can range from 0 to 12. A higher score indicates more severe disease. | 16 weeks | 
| Change from baseline in Visual Analogue Scale (VAS) assessment for Palmoplantar Pustulosis (PPP) symptoms (pruritis and pain/discomfort) at week 16 | Participants will use VAS (with scores ranging from 0 to 100, with 100 being most severe) to assess the degree of PPP pruritis and pain/discomfort and on the hands and feet | 16 weeks | 
| Change from Baseline in Dermatology Life Quality Index (DLQI) total score at week 16 | DLQI is a skin disease-specific Quality of Life (QoL) questionnaire comprised of 10 items assessing the participant's status over the previous week. A numeric score ranging from 0 to 30 is produced with higher scores indicating increased disease severity | 16 weeks | 
| Number of participants with treatment-emergent adverse events |  | 56 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPP, Palmoplantar Pustulosis, AMG 407, Apremilast, Otezla