Trial · NCT04057937
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
NCT04057937, Phase 2, Completed, Amgen; results first posted 2022-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis. Trials, record NCT04057937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04057937
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
- NCT number
- NCT04057937
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Palmoplantaris Pustulosis
- Interventions
- Apremilast, Placebo
- First posted
- 2019-08-15
- Last updated
- 2024-07-17
- Results first posted
- 2022-01-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieve a PPPASI-50 at Week 16 | At Week 16 | PPPASI-50 is defined as \>= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. |
| Secondary | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Weeks 2 to 14 | PPPASI-50 is defined as \>= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Missing values at were imputed using non-responder imputation (NRI) as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder. |
| Secondary | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Weeks 2 to 16 | PPPASI-75 is defined as \>=75 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Missing values were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder. |
| Secondary | Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16 | Baseline to Week 16 | The AUC for PPPASI total score from baseline through Week 16 is the sum of the AUCs in each time interval specified by the dates of the visits and is calculated based on the linear trapezoidal method. PPPASI is a disease-specific efficacy assessment tool to evaluate 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. |
| Secondary | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Baseline to Week 16 | PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. A positive change from baseline indicates a worsening of symptoms. |
| Secondary | Change From Baseline in PPPASI Total Score at Week 16 | Baseline and Week 16 | PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease. Change from baseline based on a mixed-effects model for repeated measures with a positive change indicating a worsening of symptoms. |
| Secondary | AUC for PPSI Total Score From Baseline Through Week 16 | Baseline to Week 16 | The AUC for PPSI total score from baseline through Week 16 is the sum of the AUCs in each time interval specified by the dates of the visits and is calculated based on the linear trapezoidal method. PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. |
| Secondary | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Baseline to Week 16 | PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. A positive change from baseline indicates a worsening of symptoms. |
| Secondary | Change From Baseline in PPSI Total Score at Week 16 | Baseline and Week 16 | PPSI is a disease-specific assessment tool for grading the severity of PPP lesions. Evaluation of skin lesion sites are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPSI produces a total numeric score that ranges from 0 to 12. A higher score indicates more severe disease. Change from baseline based on a mixed-effects model for repeated measures with a positive change indicating a worsening of symptoms. |
| Secondary | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Weeks 2 to 16 | The PGA for palms and soles was used to determine the participants PPP lesions on palms and soles. Lesions on palms and soles were graded based on the following scales: 0 = Clear 1. = Almost clear/Minimal 2. = Mild 3. = Moderate 4. = Severe 5. = Very severe. The percentage of of participants with a post baseline score of 0 or 1 (responders) are reported. Missing values at were imputed using NRI as the primary method, by which a participant without sufficient data for the response determination was considered a non-responder. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Achieve a PPPASI-50 at Week 16 | At Week 16 | Intent-to-treat (ITT) population which includes all randomized participants who received at least one dose of investigational product. | Percentage of Partcipants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Weeks 2 to 14 | ITT population which includes all randomized participants who received at least one dose of investigational product. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | Weeks 2 to 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. | Percentage of Partcipants | NUMBER |
| SECONDARY | Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16 | Baseline to Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. | Scores * Day | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | Baseline to Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Percent Change | MEAN |
| SECONDARY | Change From Baseline in PPPASI Total Score at Week 16 | Baseline and Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | AUC for PPSI Total Score From Baseline Through Week 16 | Baseline to Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. | Scores * Day | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | Baseline to Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Percent Change | MEAN |
| SECONDARY | Change From Baseline in PPSI Total Score at Week 16 | Baseline and Week 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with data available for analysis are reported. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | Weeks 2 to 16 | ITT population which includes all randomized participants who received at least one dose of investigational product. Only participants with a PGA greater than 1 at baseline are included in this analysis. | Percentage of Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group128
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 Achieve a PPPASI-50 at Week 16 | Placebo-controlled Phase - Placebo | 40.9 | Percentage of Partcipants | ||
| Percentage of Participants Who Achieve a PPPASI-50 at Week 16 | Placebo-controlled Phase - Apremilast 30 mg BID | 78.3 | Percentage of Partcipants | ||
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Placebo-controlled Phase - Placebo | Week 2 | 2.3 | Percentage of Participants | |
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Placebo-controlled Phase - Apremilast 30 mg BID | Week 2 | 30.4 | Percentage of Participants | |
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Placebo-controlled Phase - Placebo | Week 4 | 18.2 | Percentage of Participants | |
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Placebo-controlled Phase - Apremilast 30 mg BID | Week 4 | 52.2 | Percentage of Participants | |
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Placebo-controlled Phase - Placebo | Week 6 | 18.2 | Percentage of Participants | |
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Placebo-controlled Phase - Apremilast 30 mg BID | Week 6 | 69.6 | Percentage of Participants | |
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Placebo-controlled Phase - Placebo | Week 8 | 43.2 | Percentage of Participants | |
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | Placebo-controlled Phase - Apremilast 30 mg BID | Week 8 | 65.2 | Percentage of Participants |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-controlled Phase | STARTED | Placebo Then Apremilast 30mg BID | 44 | |
| Placebo-controlled Phase | STARTED | Apremilast 30 mg BID Then Apremilast 30 mg BID | 46 | |
| Placebo-controlled Phase | COMPLETED | Placebo Then Apremilast 30mg BID | 41 | |
| Placebo-controlled Phase | COMPLETED | Apremilast 30 mg BID Then Apremilast 30 mg BID | 46 | |
| Placebo-controlled Phase | NOT COMPLETED | Placebo Then Apremilast 30mg BID | 3 | |
| Placebo-controlled Phase | NOT COMPLETED | Apremilast 30 mg BID Then Apremilast 30 mg BID | 0 | |
| Active-treatment Phase | STARTED | Placebo Then Apremilast 30mg BID | 41 | |
| Active-treatment Phase | STARTED | Apremilast 30 mg BID Then Apremilast 30 mg BID | 46 | |
| Active-treatment Phase | COMPLETED | Placebo Then Apremilast 30mg BID | 40 | |
| Active-treatment Phase | COMPLETED | Apremilast 30 mg BID Then Apremilast 30 mg BID | 44 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events48
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 | Abdominal discomfort | Gastrointestinal disorders | Placebo-controlled Phase - Placebo | 1 | 44 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo-controlled Phase - Apremilast 30 mg BID | 7 | 46 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Active-treatment Phase - Apremilast 30 mg BID | 6 | 87 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-controlled Phase - Placebo | 6 | 44 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-controlled Phase - Apremilast 30 mg BID | 12 | 46 | |
| other | Diarrhoea | Gastrointestinal disorders | Active-treatment Phase - Apremilast 30 mg BID | 8 | 87 | |
| other | Faeces soft | Gastrointestinal disorders | Placebo-controlled Phase - Placebo | 2 | 44 | |
| other | Faeces soft | Gastrointestinal disorders | Placebo-controlled Phase - Apremilast 30 mg BID | 5 | 46 | |
| other | Faeces soft | Gastrointestinal disorders | Active-treatment Phase - Apremilast 30 mg BID | 3 | 87 | |
| other | Nausea | Gastrointestinal disorders | Placebo-controlled Phase - Placebo | 2 | 44 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-controlled Phase - Placebo | 0 | 44 |
| Total, all-cause mortality | Placebo-controlled Phase - Apremilast 30 mg BID | 0 | 46 |
| Total, all-cause mortality | Active-treatment Phase - Apremilast 30 mg BID | 0 | 87 |
| Total, other adverse events | Placebo-controlled Phase - Placebo | 16 | 44 |
| Total, other adverse events | Placebo-controlled Phase - Apremilast 30 mg BID | 32 | 46 |
| Total, other adverse events | Active-treatment Phase - Apremilast 30 mg BID | 40 | 87 |
| Total, serious adverse events | Placebo-controlled Phase - Placebo | 0 | 44 |
| Total, serious adverse events | Placebo-controlled Phase - Apremilast 30 mg BID | 0 | 46 |
| Total, serious adverse events | Active-treatment Phase - Apremilast 30 mg BID | 3 | 87 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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GET https://conductscience.org/api/trials/v1/NCT04057937/results?page=2