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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast | Experimental | Apremilast will be administered to participants twice daily (BID) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Nagakute-shi | Aichi-ken | 480-1195 | Japan | ||
| Nagoya City University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41297955 | Derived | 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. |
| 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.
A total of 176 participants were enrolled in the placebo-controlled period. Of these, 172 participants were enrolled in the active treatment period.
Participants with palmoplantar pustulosis (PPP) took part in the study at 40 centers in Japan between 08 March 2022 and 01 June 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-controlled Period: Placebo | Participants took oral placebo matching apremilast tablets twice daily (BID) from Week 0 to Week 16 during the placebo-controlled period. |
| FG001 | Placebo-controlled Period: Apremilast |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-controlled Period |
|
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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 15, 2022 | Mar 21, 2025 |
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| Placebo | Drug | Oral tablets |
|
| 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. | 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. | 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. | 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. | 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:
TEAEs of interest were defined as any of the following:
Clinically significant changes in body weight, vital signs and laboratory abnormalities were also recorded as TEAEs. | 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) |
| Nagoya |
| Aichi-ken |
| 467-8602 |
| Japan |
| Toho University Sakura Medical Center | Sakura-shi | Chiba | 285-8741 | Japan |
| Ehime University Hospital | Toon-shi | Ehime | 791-0295 | Japan |
| Kusuhara Dermatology Clinic | Fukuoka | Fukuoka | 811-1302 | Japan |
| Fukuoka University Hospital | Fukuoka | Fukuoka | 814-0180 | Japan |
| Higuchi Dermatology Urology Clinic | Kasuga-shi | Fukuoka | 816-0802 | Japan |
| Kurume University Hospital | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Nagata Dermatology Clinic | Ogori-shi | Fukuoka | 838-0144 | Japan |
| Fukushima Medical University Hospital | Fukushima | Fukushima | 960-1295 | Japan |
| Central Japan International Medical Center | Minokamo-shi | Gifu | 505-8510 | Japan |
| Motomachi Dermatology Clinic | Asahikawa-shi | Hokkaido | 070-0810 | Japan |
| Asahikawa Medical University Hospital | Asahikawa-shi | Hokkaido | 078-8510 | Japan |
| Medical corporation kojinkai Chitose dermatology and plastic surgery clinic | Chitose-shi | Hokkaido | 066-0021 | Japan |
| Shinoro Dermatology Clinic | Sapporo | Hokkaido | 002-8022 | Japan |
| Medical Corporation Kojinkai Kitago Dermatology Clinic | Sapporo | Hokkaido | 003-0833 | Japan |
| Shibaki Dermatology Clinic | Sapporo | Hokkaido | 006-0022 | Japan |
| Medical Corporation Kojinkai Sapporo Skin Clinic | Sapporo | Hokkaido | 060-0063 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Mito Kyodo General Hospital | Mito | Ibaraki | 310-0015 | Japan |
| Ishikawa Prefectural Central Hospital | Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| Takamatsu Red Cross Hospital | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Kagoshima University Hospital | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| Nomura Dermatology Clinic | Yokohama | Kanagawa | 221-0825 | Japan |
| Kochi Medical School Hospital | Nankoku-shi | Kochi | 783-8505 | Japan |
| Nagaoka Red Cross Hospital | Nagaoka-shi | Niigata | 940-2085 | Japan |
| Oita University Hospital | Yufu-shi | Oita Prefecture | 879-5593 | Japan |
| Nippon Life Hospital | Osaka | Osaka | 550-0006 | Japan |
| Medical Corporation Goto Dermatology Clinic | Osaka | Osaka | 554-0021 | Japan |
| Dermatology and Ophthalmology Kume Clinic | Sakai-shi | Osaka | 593-8324 | Japan |
| Yoshikawa Skin Clinic | Takatsuki-shi | Osaka | 569-0824 | Japan |
| Dokkyo Medical University Saitama Medical Center | Koshigaya-shi | Saitama | 343-8555 | Japan |
| Pansy Skin Clinic | Saitama-shi | Saitama | 330-0064 | Japan |
| Jichi Medical University Hospital | Shimotsuke-shi | Tochigi | 329-0498 | Japan |
| Tokyo Teishin Hospital | Chiyoda-ku | Tokyo | 102-8798 | Japan |
| Teikyo University Hospital | Itabashi-ku | Tokyo | 173-8606 | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku | Tokyo | 173-8610 | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Seibo International Catholic Hospital | Shinjuku-ku | Tokyo | 161-8521 | Japan |
| Yamanashi Prefectural Central Hospital | Kofu | Yamanashi | 400-8506 | Japan |
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16 during the placebo-controlled period.
| FG002 | Active Treatment Period: Apremilast | Participants who were randomized to placebo during the placebo-controlled period took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 16 to Week 52. Participants who were randomized to apremilast during the placebo-controlled period took oral 30 mg apremilast tablets BID from Week 16 to Week 52. |
| Received Apremilast or Placebo During Placebo-controlled Period |
|
| COMPLETED | Completed investigational product treatment in the placebo-controlled period. |
|
| NOT COMPLETED |
|
|
| Apremilast Active Treatment Period |
|
|
Intent-to-treat Population: Included all randomized participants (i.e., participants who entered the placebo-controlled period).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-controlled Period: Placebo | Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16. |
| BG001 | Placebo-controlled Period: Apremilast | Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 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. | ITT Population: Included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
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|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population: Included all randomized participants. Only participants with observed data, including participants who had intercurrent events and were assigned baseline values were included. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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:
TEAEs of interest were defined as any of the following:
Clinically significant changes in body weight, vital signs and laboratory abnormalities were also recorded as TEAEs. | Safety Population: Included all randomized participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | 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) |
|
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.
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 Period: Placebo | Participants took oral placebo matching apremilast tablets BID from Week 0 to Week 16. | 0 | 88 | 1 | 88 | 25 | 88 |
| EG001 | Placebo-controlled Period: Apremilast | Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16. | 0 | 88 | 1 | 88 | 46 | 88 |
| EG002 | Apremilast Exposure Period: Apremilast | Participants who received any apremilast during the placebo-controlled or active treatment periods. | 0 | 174 | 9 | 174 | 99 | 174 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pseudoaneurysm infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | 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 | Sep 25, 2023 | Mar 21, 2025 | 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
| Adverse Event |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
|
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16.
|
|
|
|
|
|
|
|
|
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16. |
|
|
|
Participants took oral apremilast tablets BID, starting at a dose of 10 mg and gradually increasing to the target 30 mg dose over 5 days, from Week 0 to Week 16. |
| OG002 | Apremilast Exposure Period: Apremilast | Participants who received any apremilast during the placebo-controlled or active treatment periods. |
|
|