Back to resultsPhase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
Primary Purpose
Palmoplantar Pustulosis
Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Apremilast
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Palmoplantar Pustulosis focused on measuring Palmoplantar Pustulosis, PPP, AMG 407, Apremilast, Otezla
Eligibility Criteria
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
Sites / Locations
- Aichi Medical University Hospital
- Nagoya City University Hospital
- Toho University Sakura Medical Center
- Ehime University Hospital
- Kusuhara Dermatology Clinic
- Fukuoka University Hospital
- Higuchi Dermatology Urology Clinic
- Kurume University Hospital
- Nagata Dermatology Clinic
- Fukushima Medical University Hospital
- Central Japan International Medical Center
- Motomachi Dermatology Clinic
- Asahikawa Medical University Hospital
- Medical corporation kojinkai Chitose dermatology and plastic surgery clinic
- Shinoro Dermatology Clinic
- Medical Corporation Kojinkai Kitago Dermatology Clinic
- Shibaki Dermatology Clinic
- Medical Corporation Kojinkai Sapporo Skin Clinic
- Kobe University Hospital
- Mito Kyodo General Hospital
- Ishikawa Prefectural Central Hospital
- Takamatsu Red Cross Hospital
- Kagoshima University Hospital
- Nomura Dermatology Clinic
- Kochi Medical School Hospital
- Nagaoka Red Cross Hospital
- Oita University Hospital
- Nippon Life Hospital
- Medical Corporation Goto Dermatology Clinic
- Dermatology and Ophthalmology Kume Clinic
- Yoshikawa Skin Clinic
- Dokkyo Medical University Saitama Medical Center
- Pansy Skin Clinic
- Jichi Medical University Hospital
- Tokyo Teishin Hospital
- Teikyo University Hospital
- Nihon University Itabashi Hospital
- Tokyo Medical University Hospital
- Seibo International Catholic Hospital
- Yamanashi Prefectural Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Apremilast
Placebo and Apremilast
Arm Description
Apremilast will be administered to participants twice daily (BID)
Matching placebo will be administered to participants twice daily (BID) until week 16. After week 16, Apremilast will be administered to participants BID.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline in PPPASI total score at week 16
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.
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
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
Number of participants with treatment-emergent adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05174065
Brief Title
Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
August 19, 2023 (Actual)
Study Completion Date
May 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantar Pustulosis
Keywords
Palmoplantar Pustulosis, PPP, AMG 407, Apremilast, Otezla
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apremilast
Arm Type
Experimental
Arm Description
Apremilast will be administered to participants twice daily (BID)
Arm Title
Placebo and Apremilast
Arm Type
Experimental
Arm Description
Matching placebo will be administered to participants twice daily (BID) until week 16. After week 16, Apremilast will be administered to participants BID.
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
Otezla, AMG 407
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in PPPASI total score at week 16
Time Frame
16 weeks
Title
Change from baseline in Palmoplantar Pustulosis Severity Index (PPSI) total score at week 16
Description
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.
Time Frame
16 weeks
Title
Change from baseline in Visual Analogue Scale (VAS) assessment for Palmoplantar Pustulosis (PPP) symptoms (pruritis and pain/discomfort) at week 16
Description
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
Time Frame
16 weeks
Title
Change from Baseline in Dermatology Life Quality Index (DLQI) total score at week 16
Description
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
Time Frame
16 weeks
Title
Number of participants with treatment-emergent adverse events
Time Frame
56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Medical University Hospital
City
Nagakute-shi
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Ehime University Hospital
City
Toon-shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kusuhara Dermatology Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1302
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Higuchi Dermatology Urology Clinic
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0802
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Nagata Dermatology Clinic
City
Ogori-shi
State/Province
Fukuoka
ZIP/Postal Code
838-0144
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Central Japan International Medical Center
City
Minokamo-shi
State/Province
Gifu
ZIP/Postal Code
505-8510
Country
Japan
Facility Name
Motomachi Dermatology Clinic
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-0810
Country
Japan
Facility Name
Asahikawa Medical University Hospital
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Medical corporation kojinkai Chitose dermatology and plastic surgery clinic
City
Chitose-shi
State/Province
Hokkaido
ZIP/Postal Code
066-0021
Country
Japan
Facility Name
Shinoro Dermatology Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
002-8022
Country
Japan
Facility Name
Medical Corporation Kojinkai Kitago Dermatology Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0833
Country
Japan
Facility Name
Shibaki Dermatology Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
006-0022
Country
Japan
Facility Name
Medical Corporation Kojinkai Sapporo Skin Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Mito Kyodo General Hospital
City
Mito-shi
State/Province
Ibaraki
ZIP/Postal Code
310-0015
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Takamatsu Red Cross Hospital
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Nomura Dermatology Clinic
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Kochi Medical School Hospital
City
Nankoku-shi
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Oita University Hospital
City
Yufu-shi
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Nippon Life Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Facility Name
Medical Corporation Goto Dermatology Clinic
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
554-0021
Country
Japan
Facility Name
Dermatology and Ophthalmology Kume Clinic
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Yoshikawa Skin Clinic
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-0824
Country
Japan
Facility Name
Dokkyo Medical University Saitama Medical Center
City
Koshigaya-shi
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Pansy Skin Clinic
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330-0064
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokyo Teishin Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
102-8798
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Seibo International Catholic Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
161-8521
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu-shi
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
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