Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
Not provided
Not provided
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 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 Baseline and 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in PPPASI Total Score at Week 16 Baseline and Week 16 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. A negative change from baseline indicates a reduction in disease severity.
The continuous endpoints collected on and after the participant experienced treatment failure as the result of intercurrent event (IE) (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the mixed-effects model for repeated measures (MMRM) application.Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16 Baseline and Week 16 The PPSI is a system used for assessing and grading the severity of PPP lesions and their response to therapy. Evaluation of skin lesion site are assessed separately for erythema, pustules/vesicle and desquamation/scale, where each are rated on a scale of 0 to 4 and summed to produce a numeric total score than can range from 0 to 12, with a higher score indicating more severe disease. A negative change from baseline indicates a reduction in disease severity.
The continuous endpoints collected on and after the participant experienced treatment failure as the result of IE (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the MMRM application.Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16 Baseline and Week 16 Participants assessed the degree of pain/discomfort symptoms on palms and soles caused by PPP on a VAS. The VAS score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no pain/discomfort and the right-hand boundary (100) represents pain/discomfort as severe as can be imagined by the participant. A negative change from baseline indicates a reduction in disease severity.
The continuous endpoints collected on and after the participant experienced treatment failure as the result of IE (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the MMRM application.Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16 Baseline and Week 16 Participants assessed the degree of pruritus itching symptoms on palms and soles caused by PPP on a VAS. The VAS score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no itch and the right-hand boundary (100) represents itch as severe as can be imagined by the participant. A negative change from baseline indicates a reduction in disease severity.
The continuous endpoints collected on and after the participant experienced treatment failure as the result of IE (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the MMRM application.Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up) TEAEs were defined as any untoward medical occurrence in a participant irrespective of a causal relationship with the study treatment that began or worsened on or after the first dose of study treatment.
A serious TEAE met at least 1 of the following criteria:
* Resulted in death.
* Was immediately life-threatening.
* Required in-patient hospitalization or prolongation of existing hospitalization.
* Resulted in persistent or significant disability/incapacity.
* Was a congenital anomaly/birth defect.
* Was any other medically important serious event.
TEAEs of interest were defined as any of the following:
* Depression.
* Serious infection.
* Risk of triggering suicide.
* Serious diarrhea, nausea and vomiting.
* Malignancies.
* Vasculitis and Vasculopathy.
* Serious Hypersensitivity.
* Weight change (weight decrease).
Clinically significant changes in body weight, vital signs and laboratory abnormalities were also recorded as TEAEs.Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 Baseline and Week 16 The DLQI is a skin disease-specific Quality of Life (QoL) questionnaire comprised of 10 items assessing the participant's status over the previous week. The DLQI was used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score ranging from 0 to 30, with a higher score indicating more severe disease. A negative change from baseline indicates a reduction in disease severity.
The continuous endpoints collected on and after the participant experienced treatment failure as the result of IE (investigational product discontinuation due to lack of efficacy, adverse event, or protocol-prohibited medication use), the baseline value of corresponding endpoint were assigned to the data on and after IE up to Week 16 regardless of the observed data. The missing data due to other reasons will not be imputed considering the MMRM application.
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