Trial · NCT05174065
Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
NCT05174065, Phase 3, Completed, Amgen; results first posted 2025-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP). Trials, record NCT05174065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05174065
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
- NCT number
- NCT05174065
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 176 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Palmoplantar Pustulosis
- Interventions
- Apremilast, Placebo
- First posted
- 2021-12-30
- Last updated
- 2025-04-09
- Results first posted
- 2025-04-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | ITT Population: Included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in PPPASI Total Score at Week 16 | Baseline and Week 16 | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16 | Baseline and Week 16 | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16 | Baseline and Week 16 | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16 | Baseline and Week 16 | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 | Baseline and Week 16 | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | Safety Population: Included all randomized participants who received at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Placebo-controlled Period: Placebo | 35.3 | 95% Confidence Interval 25.3 to 45.4 | percentage of participants | |
| 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 | Placebo-controlled Period: Apremilast | 67.8 | 95% Confidence Interval 57.9 to 77.6 | percentage of participants | |
| Change From Baseline in PPPASI Total Score at Week 16 | Placebo-controlled Period: Placebo | -5.98 | Standard Error 0.999 | score on a scale | |
| Change From Baseline in PPPASI Total Score at Week 16 | Placebo-controlled Period: Apremilast | -12.12 | Standard Error 1.002 | score on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16 | Placebo-controlled Period: Placebo | -1.9 | Standard Error 0.24 | score on a scale | |
| Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16 | Placebo-controlled Period: Apremilast | -3.4 | Standard Error 0.24 | score on a scale | |
| Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16 | Placebo-controlled Period: Placebo | -9.9 | Standard Error 2.68 | score on a scale | |
| Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16 | Placebo-controlled Period: Apremilast | -17.6 | Standard Error 2.67 | score on a scale | |
| Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16 | Placebo-controlled Period: Placebo | -7.5 | Standard Error 2.97 | score on a scale | |
| Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16 | Placebo-controlled Period: Apremilast | -18.3 | Standard Error 2.96 | score on a scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-controlled Period | STARTED | Placebo-controlled Period: Placebo | 88 | |
| Placebo-controlled Period | STARTED | Placebo-controlled Period: Apremilast | 88 | |
| Placebo-controlled Period | STARTED | Active Treatment Period: Apremilast | 0 | |
| Placebo-controlled Period | Received Apremilast or Placebo During Placebo-controlled Period | Placebo-controlled Period: Placebo | 88 | |
| Placebo-controlled Period | Received Apremilast or Placebo During Placebo-controlled Period | Placebo-controlled Period: Apremilast | 88 | |
| Placebo-controlled Period | Received Apremilast or Placebo During Placebo-controlled Period | Active Treatment Period: Apremilast | 0 | |
| Placebo-controlled Period | COMPLETED | Placebo-controlled Period: Placebo | 86 | |
| Placebo-controlled Period | COMPLETED | Placebo-controlled Period: Apremilast | 86 | |
| Placebo-controlled Period | COMPLETED | Active Treatment Period: Apremilast | 0 | |
| Placebo-controlled Period | NOT COMPLETED | Placebo-controlled Period: Placebo | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo-controlled Period: Placebo | 3 | 88 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-controlled Period: Apremilast | 17 | 88 | |
| other | Diarrhoea | Gastrointestinal disorders | Apremilast Exposure Period: Apremilast | 31 | 174 | |
| other | Faeces soft | Gastrointestinal disorders | Placebo-controlled Period: Placebo | 1 | 88 | |
| other | Faeces soft | Gastrointestinal disorders | Placebo-controlled Period: Apremilast | 15 | 88 | |
| other | Faeces soft | Gastrointestinal disorders | Apremilast Exposure Period: Apremilast | 22 | 174 | |
| other | Nausea | Gastrointestinal disorders | Placebo-controlled Period: Placebo | 1 | 88 | |
| other | Nausea | Gastrointestinal disorders | Placebo-controlled Period: Apremilast | 10 | 88 | |
| other | Nausea | Gastrointestinal disorders | Apremilast Exposure Period: Apremilast | 23 | 174 | |
| other | COVID-19 | Infections and infestations | Placebo-controlled Period: Placebo | 4 | 88 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-controlled Period: Placebo | 0 | 88 |
| Total, all-cause mortality | Placebo-controlled Period: Apremilast | 0 | 88 |
| Total, all-cause mortality | Apremilast Exposure Period: Apremilast | 0 | 174 |
| Total, other adverse events | Placebo-controlled Period: Placebo | 25 | 88 |
| Total, other adverse events | Placebo-controlled Period: Apremilast | 46 | 88 |
| Total, other adverse events | Apremilast Exposure Period: Apremilast | 99 | 174 |
| Total, serious adverse events | Placebo-controlled Period: Placebo | 1 | 88 |
| Total, serious adverse events | Placebo-controlled Period: Apremilast | 1 | 88 |
| Total, serious adverse events | Apremilast Exposure Period: Apremilast | 9 | 174 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41297955 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05174065
GET https://conductscience.org/api/trials/v1/NCT05174065/results?page=2