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

NCT05174065 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20200195
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 40

Brief 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).

Conditions

Palmoplantar Pustulosis

Keywords

Palmoplantar Pustulosis; PPP; AMG 407; Apremilast; Otezla

Outcome Measures

Primary Outcomes (1)

• 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

  A PPPASI 50 response is defined as a ≥ 50% reduction in PPPASI total score from baseline. The PPPASI is a system used for assessing and grading the severity (in terms of erythema, pustules/vesicle and desquamation/scale) and area of PPP lesions and their response to therapy. The PPPASI produces a numeric score that can range from 0 to 72, with a higher score indicating more severe disease. Participants who discontinued investigational product before week 16 due to lack of efficacy, adverse event, or use of protocol-prohibited medication (intercurrent events) were to be considered as treatment failures as the result of the intercurrent event and the PPPASI-50 values for visits on and after the intercurrent event were imputed as non-responders. The missing PPPASI-50 values due to the other reasons were imputed using the multiple imputation method.

  Baseline and Week 16

Secondary Outcomes (6)

• Change From Baseline in PPPASI Total Score at Week 16

  Baseline and Week 16

• Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16

  Baseline and Week 16

• Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16

  Baseline and Week 16

• Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16

  Baseline and Week 16

• Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

  Baseline and Week 16

Study Arms (2)

Apremilast

EXPERIMENTAL

Apremilast will be administered to participants twice daily (BID)

Drug: Apremilast

Placebo and Apremilast

EXPERIMENTAL

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; Drug: Placebo

Interventions

Apremilast DRUG

Oral tablets

Also known as: Otezla, AMG 407

Apremilast; Placebo and Apremilast

Placebo DRUG

Oral tablets

Placebo and Apremilast

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (40)

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, 480-1195, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Toho University Sakura Medical Center

Sakura-shi, Chiba, 285-8741, Japan

Location

Ehime University Hospital

Toon-shi, Ehime, 791-0295, Japan

Location

Kusuhara Dermatology Clinic

Fukuoka, Fukuoka, 811-1302, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Higuchi Dermatology Urology Clinic

Kasuga-shi, Fukuoka, 816-0802, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Nagata Dermatology Clinic

Ogori-shi, Fukuoka, 838-0144, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Central Japan International Medical Center

Minokamo-shi, Gifu, 505-8510, Japan

Location

Motomachi Dermatology Clinic

Asahikawa-shi, Hokkaido, 070-0810, Japan

Location

Asahikawa Medical University Hospital

Asahikawa-shi, Hokkaido, 078-8510, Japan

Location

Medical corporation kojinkai Chitose dermatology and plastic surgery clinic

Chitose-shi, Hokkaido, 066-0021, Japan

Location

Shinoro Dermatology Clinic

Sapporo, Hokkaido, 002-8022, Japan

Location

Medical Corporation Kojinkai Kitago Dermatology Clinic

Sapporo, Hokkaido, 003-0833, Japan

Location

Shibaki Dermatology Clinic

Sapporo, Hokkaido, 006-0022, Japan

Location

Medical Corporation Kojinkai Sapporo Skin Clinic

Sapporo, Hokkaido, 060-0063, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Mito Kyodo General Hospital

Mito, Ibaraki, 310-0015, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, 760-0017, Japan

Location

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Nomura Dermatology Clinic

Yokohama, Kanagawa, 221-0825, Japan

Location

Kochi Medical School Hospital

Nankoku-shi, Kochi, 783-8505, Japan

Location

Nagaoka Red Cross Hospital

Nagaoka-shi, Niigata, 940-2085, Japan

Location

Oita University Hospital

Yufu-shi, Oita Prefecture, 879-5593, Japan

Location

Nippon Life Hospital

Osaka, Osaka, 550-0006, Japan

Location

Medical Corporation Goto Dermatology Clinic

Osaka, Osaka, 554-0021, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai-shi, Osaka, 593-8324, Japan

Location

Yoshikawa Skin Clinic

Takatsuki-shi, Osaka, 569-0824, Japan

Location

Dokkyo Medical University Saitama Medical Center

Koshigaya-shi, Saitama, 343-8555, Japan

Location

Pansy Skin Clinic

Saitama-shi, Saitama, 330-0064, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

Tokyo Teishin Hospital

Chiyoda-ku, Tokyo, 102-8798, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Seibo International Catholic Hospital

Shinjuku-ku, Tokyo, 161-8521, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan

Location

Related Publications (1)

• Terui T, Okubo Y, Kobayashi S, Morita A, Imafuku S, Tada Y, Abe M, Strober B, Gooderham M, Zhang W, Shimauchi J, Yaguchi M, Kimura T, Ogawa R, Amouzadeh H, Murakami M. Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial. J Eur Acad Dermatol Venereol. 2025 Nov 26. doi: 10.1111/jdv.70166. Online ahead of print.

  PMID: 41297955 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 30, 2021
• Study Start: March 8, 2022
• Primary Completion: August 19, 2023
• Study Completion: June 1, 2024
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

JP (40)