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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1236-1239 | Other Identifier | WHO |
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This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations.
The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo then Apremilast 30mg BID | Experimental | Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32). |
|
| Apremilast 30 mg BID then Apremilast 30 mg BID | Experimental | Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Apremilast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve a PPPASI-50 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. | At Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | 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. |
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Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ichinomiya | Aichi-ken | 491-8558 | Japan | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37233897 | Background | Terui T, Okubo Y, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Uehara N, Handa T, Tanaka M, Zhang W, Paris M, Murakami M. Efficacy and Safety of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: Results from a Phase 2, Randomized, Placebo-Controlled Study. Am J Clin Dermatol. 2023 Sep;24(5):837-847. doi: 10.1007/s40257-023-00788-2. Epub 2023 May 26. | |
| 38896381 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
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.
Participants were randomized in a 1:1 ratio to receive either apremilast or matched placebo from Week 0 to Week 16 (placebo-controlled phase) of the study. Eligible participants then entered an active-treatment phase and received apremilast from after Week 16 to Week 32.
Japanese participants with palmoplantar pustulosis (PPP) were enrolled at 22 research centers in Japan from October 2019 to June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Apremilast 30mg BID | Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-controlled Phase |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2020 | Dec 9, 2021 |
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| Placebo | Drug | Placebo |
|
| Weeks 2 to 14 |
| Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | 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. | Weeks 2 to 16 |
| Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through 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. | Baseline to Week 16 |
| Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | 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. | Baseline to Week 16 |
| Change From Baseline in PPPASI Total Score at 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. | Baseline and Week 16 |
| AUC for PPSI Total Score From Baseline Through 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. | Baseline to Week 16 |
| Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | 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. | Baseline to Week 16 |
| Change From Baseline in PPSI Total Score at 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. | Baseline and Week 16 |
| Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | 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
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. | Weeks 2 to 16 |
| Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | 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
The percentage of of participants with at least a 2 grade improvement from baseline (stringent responders) are reported. issing 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. | Weeks 2 to 16 |
| Change From Baseline in Participant VAS Assessment for PPP Symptoms | Participants assessed the degree of both pruritus itching and skin discomfort/pain as symptoms on hands and feet caused by PPP on a VAS. Each score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no itch/pain and the right-hand boundary (100) represents itch/pain as severe as can be imagined by participant. | Baseline and Weeks 2,4,6,8,12,16 |
| Nagoya |
| Aichi-ken |
| 467-8602 |
| Japan |
| Research Site | Fukuoka | Fukuoka | 814-0180 | Japan |
| Research Site | Sapporo | Hokkaido | 060-0063 | Japan |
| Research Site | Hitachi | Ibaraki | 317-0077 | Japan |
| Research Site | Sagamihara-shi | Kanagawa | 252-0392 | Japan |
| Research Site | Yokohoma-shi | Kanagawa | 221-0825 | Japan |
| Research Site | Yokosuka | Kanagawa | 238-8558 | Japan |
| Research Site | Izumo | Shimane | 693-8501 | Japan |
| Research Site | Chiyoda-ku | Tokyo | 102-8798 | Japan |
| Research Site | Itabashi-ku | Tokyo | 173-8606 | Japan |
| Research Site | Itabashi-ku | 173-8610 | Japan |
| Research Site | Kisarazu | 292-8535 | Japan |
| Research Site | Kofu | 400-0027 | Japan |
| Research Site | Minokamo | 505-8503 | Japan |
| Research Site | Nankoku-shi | 783-8505 | Japan |
| Research Site | Osaka | 550-0006 | Japan |
| Research Site | Sendai | 980-8574 | Japan |
| Research Site | Shinjuku-ku | 161-8521 | Japan |
| Research Site | Shinjyuku-ku | 160-0023 | Japan |
| Research Site | Tōon | 791-0295 | Japan |
| Research Site | Tsu | 514-8507 | Japan |
| Background |
| Okubo Y, Terui T, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Kimura T, Shimauchi J, Zhang W, Amouzadeh H, Murakami M. Exploratory Efficacy Evaluation of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: 32-Week Results from a Phase 2, Randomized, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2024 Jul;14(7):1863-1873. doi: 10.1007/s13555-024-01195-z. Epub 2024 Jun 19. |
| FG001 |
| Apremilast 30 mg BID Then Apremilast 30 mg BID |
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32). |
| COMPLETED |
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| NOT COMPLETED |
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| Active-treatment Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Apremilast 30mg BID | Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32). |
| BG001 | Apremilast 30 mg BID Then Apremilast 30 mg BID | Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Palmo-plantar Pustulosis Area and Severity Index (PPPASI) Score | PPPASI is a disease-specific efficacy assessment tool to evaluate 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. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| Palmo-plantar Severity Index (PPSI) Total Score | 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. | Mean | Standard Deviation | Score on a Scale |
| ||||||||||||||
| Physician's Global Assessment (PGA) Score for Palms and Soles | The PGA for palms and soles is used to determine the participants' PPP lesions on palms and soles. Lesions on palms and soles are graded from 0-5 with a higher score indicating more severe disease. The number of participants with each of the PGA score categories at baseline are reported: 0 = Clear
| Count of Participants | Participants |
| |||||||||||||||
| Participants Visual Analogue Scale (VAS) Assessment for PPP Symptoms | Participants assessed the degree of both pruritus itching and skin discomfort/pain as symptoms on hands and feet caused by PPP on a VAS. Each score ranges from 0 to 100. The left-hand boundary (0) on the VAS represents no itch/pain and the right-hand boundary (100) represents itch/pain as severe as can be imagined by the participant. | VAS assessment was missed by 2 participants in the placebo arm at baseline. | Mean | Standard Deviation | Score on a Scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieve a PPPASI-50 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. | Intent-to-treat (ITT) population which includes all randomized participants who received at least one dose of investigational product. | Posted | Number | Percentage of Partcipants | At Week 16 |
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| Secondary | Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase | 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. | ITT population which includes all randomized participants who received at least one dose of investigational product. | Posted | Number | Percentage of Participants | Weeks 2 to 14 |
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| Secondary | Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase | 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. | ITT population which includes all randomized participants who received at least one dose of investigational product. | Posted | Number | Percentage of Partcipants | Weeks 2 to 16 |
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| Secondary | Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through 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. | ITT population which includes all randomized participants who received at least one dose of investigational product. | Posted | Least Squares Mean | 95% Confidence Interval | Scores * Day | Baseline to Week 16 |
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| Secondary | Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase . | 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. | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline to Week 16 |
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| Secondary | Change From Baseline in PPPASI Total Score at 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. | 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. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and Week 16 |
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| Secondary | AUC for PPSI Total Score From Baseline Through 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. | ITT population which includes all randomized participants who received at least one dose of investigational product. | Posted | Least Squares Mean | 95% Confidence Interval | Scores * Day | Baseline to Week 16 |
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| Secondary | Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase | 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. | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline to Week 16 |
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| Secondary | Change From Baseline in PPSI Total Score at 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. | 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. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and Week 16 |
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| Secondary | Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase | 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
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. | 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. | Posted | Number | Percentage of Participants | Weeks 2 to 16 |
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| Secondary | Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase. | 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
The percentage of of participants with at least a 2 grade improvement from baseline (stringent responders) are reported. issing 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. | 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. | Posted | Number | Percentage of Participants | Weeks 2 to 16 |
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| Secondary | Change From Baseline in Participant VAS Assessment for PPP Symptoms | Participants assessed the degree of both pruritus itching and skin discomfort/pain as symptoms on hands and feet caused by PPP on a VAS. Each score ranged from 0 to 100. The left-hand boundary (0) on the VAS represents no itch/pain and the right-hand boundary (100) represents itch/pain as severe as can be imagined by participant. | 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. | Posted | Mean | Standard Deviation | Units on scale | Baseline and Weeks 2,4,6,8,12,16 |
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Placebo-controlled Phase: Week 0 to Week 16. Active-treatment Phase: After Week 16 to Week 32.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo-controlled Phase - Placebo | Participants received matched placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16). | 0 | 44 | 0 | 44 | 16 | 44 |
| EG001 | Placebo-controlled Phase - Apremilast 30 mg BID | Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). | 0 | 46 | 0 | 46 | 32 | 46 |
| EG002 | Active-treatment Phase - Apremilast 30 mg BID | All participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (after Week 16 to Week 32). | 0 | 87 | 3 | 87 | 40 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pustulotic arthro-osteitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2021 | Dec 9, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C505730 | apremilast |
Not provided
Not provided
Not provided
| Physician Decision |
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| 1 = Almost clear/Minimal |
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| 2 = Mild |
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| 3 = Moderate |
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| 4 = Severe |
|
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| 5 = Very severe |
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| Discomfort/Pain |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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