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

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Palmoplantar Pustulosis
• Intervention / Treatment: Drug: Placebo; Drug: Apremilast

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagakute-shi, Aichi, Japan, 480-1195
      • Aichi Medical University Hospital
    • Nagoya-shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
  • Chiba
    • Sakura-shi, Chiba, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Ehime
    • Toon-shi, Ehime, Japan, 791-0295
      • Ehime University Hospital
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital
    • Fukuoka-shi, Fukuoka, Japan, 811-1302
      • Kusuhara Dermatology Clinic
    • Kasuga-shi, Fukuoka, Japan, 816-0802
      • Higuchi Dermatology Urology Clinic
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
    • Ogori-shi, Fukuoka, Japan, 838-0144
      • Nagata Dermatology Clinic
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital
  • Gifu
    • Minokamo-shi, Gifu, Japan, 505-8510
      • Central Japan International Medical Center
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-0810
      • Motomachi Dermatology Clinic
    • Asahikawa-shi, Hokkaido, Japan, 078-8510
      • Asahikawa Medical University Hospital
    • Chitose-shi, Hokkaido, Japan, 066-0021
      • Medical corporation kojinkai Chitose dermatology and plastic surgery clinic
    • Sapporo-shi, Hokkaido, Japan, 060-0063
      • Medical Corporation Kojinkai Sapporo Skin Clinic
    • Sapporo-shi, Hokkaido, Japan, 002-8022
      • Shinoro Dermatology Clinic
    • Sapporo-shi, Hokkaido, Japan, 003-0833
      • Medical Corporation Kojinkai Kitago Dermatology Clinic
    • Sapporo-shi, Hokkaido, Japan, 006-0022
      • Shibaki Dermatology Clinic
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Ibaraki
    • Mito-shi, Ibaraki, Japan, 310-0015
      • Mito Kyodo General Hospital
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8530
      • Ishikawa Prefectural Central Hospital
  • Kagawa
    • Takamatsu-shi, Kagawa, Japan, 760-0017
      • Takamatsu Red Cross Hospital
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 890-8520
      • Kagoshima University Hospital
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 221-0825
      • Nomura Dermatology Clinic
  • Kochi
    • Nankoku-shi, Kochi, Japan, 783-8505
      • Kochi Medical School Hospital
  • Niigata
    • Nagaoka-shi, Niigata, Japan, 940-2085
      • Nagaoka Red Cross Hospital
  • Oita
    • Yufu-shi, Oita, Japan, 879-5593
      • Oita University Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan, 550-0006
      • Nippon Life Hospital
    • Osaka-shi, Osaka, Japan, 554-0021
      • Medical Corporation Goto Dermatology Clinic
    • Sakai-shi, Osaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
    • Takatsuki-shi, Osaka, Japan, 569-0824
      • Yoshikawa Skin Clinic
  • Saitama
    • Koshigaya-shi, Saitama, Japan, 343-8555
      • Dokkyo Medical University Saitama Medical Center
    • Saitama-shi, Saitama, Japan, 330-0064
      • Pansy Skin Clinic
  • Tochigi
    • Shimotsuke-shi, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 102-8798
      • Tokyo Teishin Hospital
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital
    • Shinjuku-ku, Tokyo, Japan, 161-8521
      • Seibo International Catholic Hospital
  • Yamanashi
    • Kofu-shi, Yamanashi, Japan, 400-8506
      • Yamanashi Prefectural Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): August 19, 2023
• Study Completion (Estimated): June 6, 2024

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Apremilast; Otezla; Palmoplantar Pustulosis; PPP; AMG 407
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: 20200195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes