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

Phase 3

Completed

• Conditions: Palmoplantar Pustulosis
• Interventions: Drug: Apremilast; Drug: Placebo

• Registration Number: NCT05174065
• Lead Sponsor: Amgen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-30
• Study Start: 2022-03-08
• Primary Completion: 2023-08-19
• Disposition First Posted: 2024-02-01
• Disposition First Submitted: 2024-04-19
• Study Completion: 2024-06-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and Apremilast	Placebo	Matching placebo will be administered to participants twice daily (BID) until week 16. After week 16, Apremilast will be administered to participants BID.
Apremilast	Apremilast	Apremilast will be administered to participants twice daily (BID)
Placebo and Apremilast	Apremilast	Matching placebo will be administered to participants twice daily (BID) until week 16. After week 16, Apremilast will be administered to participants BID.

Primary Outcome Measures

Name	Time	Method
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	16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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	16 weeks	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.
Change from baseline in Visual Analogue Scale (VAS) assessment for Palmoplantar Pustulosis (PPP) symptoms (pruritis and pain/discomfort) at week 16	16 weeks	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
Change from Baseline in Dermatology Life Quality Index (DLQI) total score at week 16	16 weeks	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
Number of participants with treatment-emergent adverse events	56 weeks

Trial Locations

Locations (40)

Nihon University Itabashi Hospital; 🇯🇵 Itabashi-ku, Tokyo, Japan

Seibo International Catholic Hospital; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Medical corporation kojinkai Chitose dermatology and plastic surgery clinic; 🇯🇵 Chitose-shi, Hokkaido, Japan

Medical Corporation Kojinkai Sapporo Skin Clinic; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Aichi Medical University Hospital; 🇯🇵 Nagakute-shi, Aichi, Japan

Toho University Sakura Medical Center; 🇯🇵 Sakura-shi, Chiba, Japan

Ehime University Hospital; 🇯🇵 Toon-shi, Ehime, Japan

Nagoya City University Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Kusuhara Dermatology Clinic; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Kurume University Hospital; 🇯🇵 Kurume-shi, Fukuoka, Japan

Higuchi Dermatology Urology Clinic; 🇯🇵 Kasuga-shi, Fukuoka, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Nagata Dermatology Clinic; 🇯🇵 Ogori-shi, Fukuoka, Japan

Fukushima Medical University Hospital; 🇯🇵 Fukushima-shi, Fukushima, Japan

Motomachi Dermatology Clinic; 🇯🇵 Asahikawa-shi, Hokkaido, Japan

Central Japan International Medical Center; 🇯🇵 Minokamo-shi, Gifu, Japan

Asahikawa Medical University Hospital; 🇯🇵 Asahikawa-shi, Hokkaido, Japan

Shinoro Dermatology Clinic; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Medical Corporation Kojinkai Kitago Dermatology Clinic; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Shibaki Dermatology Clinic; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Mito Kyodo General Hospital; 🇯🇵 Mito-shi, Ibaraki, Japan

Kobe University Hospital; 🇯🇵 Kobe-shi, Hyogo, Japan

Takamatsu Red Cross Hospital; 🇯🇵 Takamatsu-shi, Kagawa, Japan

Ishikawa Prefectural Central Hospital; 🇯🇵 Kanazawa-shi, Ishikawa, Japan

Kagoshima University Hospital; 🇯🇵 Kagoshima-shi, Kagoshima, Japan

Nomura Dermatology Clinic; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Nagaoka Red Cross Hospital; 🇯🇵 Nagaoka-shi, Niigata, Japan

Kochi Medical School Hospital; 🇯🇵 Nankoku-shi, Kochi, Japan

Dermatology and Ophthalmology Kume Clinic; 🇯🇵 Sakai-shi, Osaka, Japan

Oita University Hospital; 🇯🇵 Yufu-shi, Oita, Japan

Medical Corporation Goto Dermatology Clinic; 🇯🇵 Osaka-shi, Osaka, Japan

Nippon Life Hospital; 🇯🇵 Osaka-shi, Osaka, Japan

Yoshikawa Skin Clinic; 🇯🇵 Takatsuki-shi, Osaka, Japan

Dokkyo Medical University Saitama Medical Center; 🇯🇵 Koshigaya-shi, Saitama, Japan

Pansy Skin Clinic; 🇯🇵 Saitama-shi, Saitama, Japan

Jichi Medical University Hospital; 🇯🇵 Shimotsuke-shi, Tochigi, Japan

Tokyo Teishin Hospital; 🇯🇵 Chiyoda-ku, Tokyo, Japan

Teikyo University Hospital; 🇯🇵 Itabashi-ku, Tokyo, Japan

Yamanashi Prefectural Central Hospital; 🇯🇵 Kofu-shi, Yamanashi, Japan

Tokyo Medical University Hospital; 🇯🇵 Shinjuku-ku, Tokyo, Japan