Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
NCT ID: NCT05174065
Last Updated: 2025-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
176 participants
INTERVENTIONAL
2022-03-08
2024-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Apremilast
Apremilast will be administered to participants twice daily (BID)
Apremilast
Oral tablets
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.
Apremilast
Oral tablets
Placebo
Oral tablets
Interventions
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Apremilast
Oral tablets
Placebo
Oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Toho University Sakura Medical Center
Sakura-shi, Chiba, Japan
Ehime University Hospital
Toon-shi, Ehime, Japan
Kusuhara Dermatology Clinic
Fukuoka, Fukuoka, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Higuchi Dermatology Urology Clinic
Kasuga-shi, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Nagata Dermatology Clinic
Ogori-shi, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Central Japan International Medical Center
Minokamo-shi, Gifu, Japan
Motomachi Dermatology Clinic
Asahikawa-shi, Hokkaido, Japan
Asahikawa Medical University Hospital
Asahikawa-shi, Hokkaido, Japan
Medical corporation kojinkai Chitose dermatology and plastic surgery clinic
Chitose-shi, Hokkaido, Japan
Shinoro Dermatology Clinic
Sapporo, Hokkaido, Japan
Medical Corporation Kojinkai Kitago Dermatology Clinic
Sapporo, Hokkaido, Japan
Shibaki Dermatology Clinic
Sapporo, Hokkaido, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Nomura Dermatology Clinic
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital
Nankoku-shi, Kochi, Japan
Nagaoka Red Cross Hospital
Nagaoka-shi, Niigata, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, Japan
Nippon Life Hospital
Osaka, Osaka, Japan
Medical Corporation Goto Dermatology Clinic
Osaka, Osaka, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai-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
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Seibo International Catholic Hospital
Shinjuku-ku, Tokyo, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20200195
Identifier Type: -
Identifier Source: org_study_id
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