Palmoplantar PustulosisPhase 3NCT05174065
Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
A Phase 3 study testing Apremilast in people with Palmoplantar Pustulosis, run by Amgen at 40 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Palmoplantar Pustulosis
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 40 sitesJapan
- Study dates
- 8 Mar 2022to 1 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Japan40 sites
Motomachi Dermatology Clinic
Asahikawa-shi, Hokkaido, 070-0810
Asahikawa Medical University Hospital
Asahikawa-shi, Hokkaido, 078-8510
Medical corporation kojinkai Chitose dermatology and plastic surgery clinic
Chitose-shi, Hokkaido, 066-0021
Tokyo Teishin Hospital
Chiyoda-ku, Tokyo, 102-8798
Kusuhara Dermatology Clinic
Fukuoka, Fukuoka, 811-1302
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530
Higuchi Dermatology Urology Clinic
Kasuga-shi, Fukuoka, 816-0802
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, 343-8555
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Central Japan International Medical Center
Minokamo-shi, Gifu, 505-8510
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, 480-1195
Nagaoka Red Cross Hospital
Nagaoka-shi, Niigata, 940-2085
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Kochi Medical School Hospital
Nankoku-shi, Kochi, 783-8505
Nagata Dermatology Clinic
Ogori-shi, Fukuoka, 838-0144
Nippon Life Hospital
Osaka, Osaka, 550-0006
Medical Corporation Goto Dermatology Clinic
Osaka, Osaka, 554-0021
Pansy Skin Clinic
Saitama-shi, Saitama, 330-0064
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, 593-8324
Toho University Sakura Medical Center
Sakura-shi, Chiba, 285-8741
Shinoro Dermatology Clinic
Sapporo, Hokkaido, 002-8022
Medical Corporation Kojinkai Kitago Dermatology Clinic
Sapporo, Hokkaido, 003-0833
Shibaki Dermatology Clinic
Sapporo, Hokkaido, 006-0022
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hokkaido, 060-0063
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Seibo International Catholic Hospital
Shinjuku-ku, Tokyo, 161-8521
Teikyo University Hospital
tabashi City, Tokyo, 173-8606
Nihon University Itabashi Hospital
tabashi City, Tokyo, 173-8610
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017
Yoshikawa Skin Clinic
Takatsuki-shi, Osaka, 569-0824
Ehime University Hospital
Toon-shi, Ehime, 791-0295
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825
Oita University Hospital
Yufu-shi, Oita Prefecture, 879-5593
About this study
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)
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
- Being tested
- Apremilast, Placebo
- Keywords
- Palmoplantar Pustulosis, PPP, AMG 407, Apremilast, Otezla
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla, AMG 407
Oral tablets
PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | Apremilast will be administered to participants twice daily (BID) Receives: 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. Receives: Drug: Apremilast; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 16
Secondary outcomes (6)
Change From Baseline in PPPASI Total Score at 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.
Measured: Baseline and Week 16
Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at 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.
Measured: Baseline and Week 16
Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at 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.
Measured: Baseline and Week 16
Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at 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.
Measured: Baseline and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at 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.
Measured: Baseline and Week 16
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start8 Mar 2022
- Primary completion19 Aug 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palmoplantar PustulosisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174065
- Sponsor's protocol ID
- 20200195
- Status last verified
- Feb 2025
- First submitted
- 14 Dec 2021
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Publications
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. 2026 Jun;40(6):994-1004. doi: 10.1111/jdv.70166. Epub 2025 Nov 26.
PubMed 41297955
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05174065
- Acronym / sponsor ID
- 20200195
- Conditions
- Palmoplantar Pustulosis
- Keywords
- Palmoplantar Pustulosis, PPP, AMG 407, Apremilast, Otezla
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 19 Aug 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: ApremilastApremilast will be administered to participants twice daily (BID) |
| Placebo and Apremilast | Experimental | Drug: Apremilast, Drug: PlaceboMatching placebo will be administered to participants twice daily (BID) until week 16. After week 16, Apremilast will be administered to participants BID. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (13 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastAlso: Otezla, AMG 407Oral tablets | Drug | Apremilast, Placebo and Apremilast |
| PlaceboOral tablets | Drug | Placebo and Apremilast |
Primary outcome
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
Time frame: 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.
6 secondary outcomes
Change From Baseline in PPPASI Total Score at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16
Time frame: Baseline and Week 16
Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Time frame: Baseline and Week 16
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41297955Terui 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. 2026 Jun;40(6):994-1004. doi: 10.1111/jdv.70166. Epub 2025 Nov 26.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast in people with Palmoplantar Pustulosis, run by Amgen at 40 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05174065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.