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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1230-7468 | Registry Identifier | WHO | |
| 20200062 | Other Identifier | Amgen Study ID |
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The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.
Participants will be enrolled at 28 sites in Japan. The study consists of 4 phases: a screening phase (4 weeks), an open-label combination therapy phase (16 weeks), an open-label combination therapy phase with optional topical reduction (16 weeks), and a post-treatment observational follow-up phase (4 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast | Experimental | After a 5-day titration, participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16 participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Tablets for oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16 | The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear;
The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32 | The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear;
|
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Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF) with plaque psoriasis.
Subject has understood and voluntarily signed an informed consent document prior to any study related assessments/procedures being conducted.
Subject is able to adhere to the study visit schedule and other protocol requirements.
Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior to Baseline.
Subject has psoriasis with sPGA = 2 or 3 at screening and baseline.
Subject is currently treated for psoriasis with topical therapies only for at least 4 weeks prior to Baseline.
Subject has inadequate response to current topical therapy as per Investigator's discretion.
Subject is naïve to all biologic therapies for psoriasis vulgaris.
Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories.
(NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
Subjects that are females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
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 | Erlangen | 91054 | Germany | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38801606 | Derived | Abe M, Okubo Y, Takahashi H, Endo K, Chaudhari S, Deignan C, Amouzadeh H, Hino R. Consistent Efficacy of Apremilast in Patients with Psoriasis Regardless of Baseline Disease Severity or Special Area Involvement: Subgroup Analysis from PROMINENT. Dermatol Ther (Heidelb). 2024 Jun;14(6):1587-1597. doi: 10.1007/s13555-024-01179-z. Epub 2024 May 27. | |
| 35689737 |
| 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.
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This study was conducted at 28 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apremilast | Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Weeks 0 to 16 |
|
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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 28, 2020 | Dec 20, 2021 |
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| Topical Therapy | Drug | Participants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician. |
|
| Week 32 |
| Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32 | The ScPGA assesses scalp involvement of psoriasis based on scalp plaque elevation, scaling, and erythema. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe). | Weeks 16 and 32 |
| Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32 | The overall body surface area affected by psoriasis was estimated based on the palm area of the participant's hand, which equates to approximately 1% of total body surface area. BSA affected by psoriasis is expressed as a percentage of total body surface area. A negative change from baseline indicates improvement. | Baseline and weeks 16 and 32 |
| Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32 | Participants were asked to indicate how much itch they have had due to psoriasis in the past week by placing a vertical stroke on a 100 mm line on which the left-hand boundary (0 mm) represented no itch, and the right-hand boundary (100 mm) represented worst itch imaginable. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement. | Baseline and weeks 2, 16, and 32 |
| Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 | Shiratori's Pruritus Severity Score is a pruritus (itchiness) severity assessment tool used in Japan. Daytime and nighttime pruritus were evaluated and scored separately. Daytime pruritus was rated on a five-grade scale: 0 (absent), 1 (endurable without scratching; minimal), 2 (subsides with slight scratching; mild), 3 (subsides with considerable scratching; moderate), or 4 (not subsiding with scratching, which prompts repeated scratching; severe). Nighttime pruritus was rated on a five-grade scale: 0 (absent), 1 (slight itching at bedtime but not causing intentional scratching; no difficulty sleeping because of pruritus), 2 (slight itching that subsides with scratching; no difficulty sleeping because of pruritus), 3 (difficulty sleeping because of pruritus that resolves with scratching; unconscious scratching occurs during sleep), or 4 (severe difficulty sleeping due to pruritus; frequent scratching that worsens pruritus). A negative change from baseline indicates improvement. | Baseline and weeks 2, 16, and 32 |
| Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline | One target thumb nail or fingernail representing the worst nail psoriasis involvement was selected for assessment at Baseline. The nail matrix was assessed for presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling) graded on a scale of 0 (none) to 4 (present in all 4 quadrants). The nail bed was assessed for the presence of any nail bed features (onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma) on a scale from 0 (none) to 4 (present in all quadrants). The sum of the nail matrix and nail bed scores is the total score and ranges from 0 to 8 (worst). | Weeks 16 and 32 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32 | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much), except for Question 7, which first asks whether the participant's skin prevented them from working or studying (Yes (score = 3) or No (score = 0), then If "No", the participant is asked how much their skin was a problem at work or studying over the last week, with responses from 0 (not at all), 1 (a little), or 2 (a lot). The DLQI total score ranges from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A negative change from baseline indicates improvement. | Baseline and weeks 16 and 32 |
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32 | The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement. | Baseline and weeks 16 and 32 |
| Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75) | The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. | Weeks 16 and 32 |
| Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50) | The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. | Weeks 16 and 32 |
| Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores | The Treatment Satisfaction Questionnaire for Medication (TSQM) version II is a self-administered instrument to understand a participant's satisfaction on current therapy. The TSQM comprises 11 items across 4 domains focusing on effectiveness (Item 1 and 2), side effects (Item 4 to 6), convenience (Item 7 to 9), and global satisfaction (Item 10 and 11). With the exception of Item 3 (experience any side effects; yes or no), all items have five or seven responses. Item scores are summed to give four domain scores, which are in turn transformed to a scale from 0 (extremely dissatisfied) to 100 (extremely satisfied). | Baseline and weeks 16 and 32 |
| Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32 | The Patient Benefit Index (PBI) is used to assess patient-relevant benefits of psoriasis treatment as a function of the most important needs identified by the participant before the start of treatment. Participants were asked to assess the benefits of treatment by completing the Patient Benefit Questionnaire (PBQ), which consists of 25 treatment goal statements scored from 0 (not at all) to 4 (very). The PBI is calculated for each participant by weighing the achievement values of each statement by their importance to the individual patient as assessed prior to the start of treatment. The PBI ranges from 0 (no benefit) to 4 (maximum benefit). | Weeks 16 and 32 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | The Investigator assessed the severity/intensity of each adverse event as: Mild (asymptomatic or mild symptoms; intervention not indicated; activities of daily life (ADLs) minimally or not affected); Moderate (symptom(s) cause moderate discomfort; local or noninvasive intervention indicated; more than minimal interference with ADLs but able to carry out daily social and functional activities; drug therapy may be required); Severe (symptoms causing severe discomfort/pain; symptoms requiring medical/surgical attention/intervention; interference with ADLs including inability to perform daily social and functional activities; drug therapy required). A serious adverse event is any AE occurring at any dose that:
| From first dose of study drug until at least 28 days after last dose; up to 36 weeks. |
| Fukuoka |
| Fukuoka |
| 814-0180 |
| Japan |
| Research Site | Fukuoka-shi, Fukuoka | Fukuoka | 813-0044 | Japan |
| Research Site | Fukuoka-shi, Fukuoka | Fukuoka | 819-0167 | Japan |
| Research Site | Obihiro-shi | Hokkaido | 080-0013 | Japan |
| Research Site | Sapporo | Hokkaido | 060-0063 | Japan |
| Research Site | Sapporo | Hokkaido | 062-0042 | Japan |
| Research Site | Sakai-shi | Osaka | 593-8324 | Japan |
| Research Site | Bunkyo-ku | Tokyo | 113-8603 | Japan |
| Research Site | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Motomachi Dermatology Clinic | Asahikawa-shi, Hokkaido | 070-0810 | Japan |
| Research Site | Asahikawa-shi, Hokkaido | 070-0810 | Japan |
| Nippon Medical School Hospital | Bunkyō City | 113-8602 | Japan |
| The University of Tokyo Hospital | Bunkyō City | 113-8655 | Japan |
| Chitose Dermatology and Plastic, Reconstructive Surgery Clinic | Chitose | 066-0021 | Japan |
| Research Site | Chitose | 066-0021 | Japan |
| Kiryu Dermatology Clinic | Fukuoka-shi, Fukuoka | 813-0044 | Japan |
| Fukuoka University Hospital | Fukuoka-shi, Fukuoka | 814-0180 | Japan |
| Tomoko Matsuda Dermatology Clinic | Fukuoka-shi, Fukuoka | 819-0167 | Japan |
| Hino Dermatology Clinic | Fukutsu | 811-3217 | Japan |
| Research Site | Fukutsu | 811-3217 | Japan |
| Research Site | Kagoshima | 890-0055 | Japan |
| Saruwatari Dermatology Clinic | Kagoshima | 890-0055 | Japan |
| Noguchi Dermatorogy Clinic | Kamimashiki-gun | 861-3101 | Japan |
| Research Site | Kamimashiki-gun | 861-3101 | Japan |
| Japan Community Health-care Organization Kyushu Hospital | Kitakyushu | 806-8501 | Japan |
| Research Site | Kitakyushu | 806-8501 | Japan |
| Maruyama Dermatology Clinic | Koto-ku, Tokyo | 136-0074 | Japan |
| Research Site | Koto-ku, Tokyo | 136-0074 | Japan |
| Mita Dermatology Clinic | Minatoku | 108-0014 | Japan |
| Research Site | Minatoku | 108-0014 | Japan |
| Iwate Medical University Uchimaru Medical Center | Morioka | 020-8505 | Japan |
| Research Site | Morioka | 020-8505 | Japan |
| Research Site | Neyagawa | 572-0838 | Japan |
| Yoshioka Dermatology Clinic | Neyagawa | 572-0838 | Japan |
| Takagi Dermatological Clinic | Obihiro | 080-0013 | Japan |
| Nippon Life Hospital | Osaka | 550-0006 | Japan |
| Research Site | Osaka | 550-0006 | Japan |
| Hino Clinic | Sakai | 599-8272 | Japan |
| Research Site | Sakai | 599-8272 | Japan |
| Kume Clinic | Sakai-shi, Osaka | 593-8324 | Japan |
| Kitagou Dermatology Clinic | Sapporo | 003-0833 | Japan |
| Research Site | Sapporo | 003-0833 | Japan |
| Kobayashi Skin Clinic | Sapporo | 060-0807 | Japan |
| Research Site | Sapporo | 060-0807 | Japan |
| Hosui Medical Clinic | Sapporo | 064-0807 | Japan |
| Research Site | Sapporo | 064-0807 | Japan |
| Sapporo Skin Clinic | Sapporo-shi, Hokkaido | 060-0063 | Japan |
| Fukuzumi Dermatology Clinic | Sapporo-shi, Hokkaido | 062-0042 | Japan |
| Jichi Medical University Hospital | Shimotsuke | 329-0498 | Japan |
| Research Site | Shimotsuke | 329-0498 | Japan |
| NTT Medical Center Tokyo | Shinagawa-ku, Tokyo | 141-8625 | Japan |
| Research Site | Shinjyuku-ku | 160-0023 | Japan |
| Tokyo Medical University Hospital | Shinjyuku-ku | 160-0023 | Japan |
| Fujita Health University Hospital | Toyoake | 470-1192 | Japan |
| Research Site | Toyoake | 470-1192 | Japan |
| Okubo Y, Takahashi H, Hino R, Endo K, Kikuchi S, Ozeki Y, Nakamura T, Paris M, Abe M. Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study. Dermatol Ther (Heidelb). 2022 Jun;12(6):1469-1480. doi: 10.1007/s13555-022-00747-5. Epub 2022 Jun 11. |
| Received Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
|
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| Weeks 16 to 32 |
|
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Apremilast | Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician. |
| 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 |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Duration of Plaque Psoriasis | Mean | Standard Deviation | years |
| |||||||||||||||||
| Body Surface Area (BSA) Affected by Psoriasis | The overall body surface area affected by psoriasis was estimated based on the palm area of the participant's hand, which equates to approximately 1% of total body surface area. BSA affected by psoriasis is expressed as a percentage of total body surface area. | Mean | Standard Deviation | percentage of total body surface area |
| ||||||||||||||||
| Static Physician's Global Assessment (sPGA) Score | The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA was calculated by averaging the total body erythema, induration, and desquamation scores. Erythema (E), induration (I), and desquamation (D) were scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The overall scores are as follows: 0 = Clear;
| Count of Participants | Participants |
| |||||||||||||||||
| Scalp Physicians Global Assessment (ScPGA) | The ScPGA assesses scalp involvement of psoriasis. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe). | Count of Participants | Participants |
| |||||||||||||||||
| Baseline Psoriasis Area Severity Index (PASI) Score | The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||||
| Pruritus Visual Analog Scale (VAS) Score | Participants were asked to indicate how much itch they have had due to psoriasis in the past week by placing a vertical stroke on a 100 mm line on which the left-hand boundary (0 mm) represented no itch, and the right-hand boundary (100 mm) represented worst itch imaginable. The distance from the mark to the left-hand boundary was recorded. | Mean | Standard Deviation | mm |
| ||||||||||||||||
| Baseline NAPSI Score for the Target Nail | One target thumb nail or fingernail representing the worst nail psoriasis involvement was selected for assessment at Baseline. The nail matrix was assessed for presence of any of the nail matrix features graded on a scale of 0 (none) to 4 (present in all 4 quadrants). The nail bed was assessed for the presence of any nail bed features on a scale from 0 (none) to 4 ( present in all quadrants). The sum of the nail matrix and nail bed scores is the total score and ranges from 0 to 8 (worst). | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||||
| Dermatology Life Quality Index (DLQI) Score | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 (best quality of life) to 30 (worst quality of life). | Mean | Standard Deviation | scores on a scale |
|
| 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 an sPGA Score of Clear (0) or Almost Clear (1) at Week 16 | The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear;
The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets. | The enrolled population; missing values through week 16 were imputed using the multiple imputation (MI) method. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32 | The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear;
| The enrolled population; missing values through week 32 were imputed using non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 32 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32 | The ScPGA assesses scalp involvement of psoriasis based on scalp plaque elevation, scaling, and erythema. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe). | The enrolled population with Baseline ScPGA Score ≥ 2; missing values were imputed using non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 16 and 32 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32 | The overall body surface area affected by psoriasis was estimated based on the palm area of the participant's hand, which equates to approximately 1% of total body surface area. BSA affected by psoriasis is expressed as a percentage of total body surface area. A negative change from baseline indicates improvement. | The enrolled population with available data at each time point | Posted | Mean | Standard Deviation | percent BSA | Baseline and weeks 16 and 32 |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32 | Participants were asked to indicate how much itch they have had due to psoriasis in the past week by placing a vertical stroke on a 100 mm line on which the left-hand boundary (0 mm) represented no itch, and the right-hand boundary (100 mm) represented worst itch imaginable. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement. | The enrolled population with available data at each time point | Posted | Mean | Standard Deviation | percent change | Baseline and weeks 2, 16, and 32 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 | Shiratori's Pruritus Severity Score is a pruritus (itchiness) severity assessment tool used in Japan. Daytime and nighttime pruritus were evaluated and scored separately. Daytime pruritus was rated on a five-grade scale: 0 (absent), 1 (endurable without scratching; minimal), 2 (subsides with slight scratching; mild), 3 (subsides with considerable scratching; moderate), or 4 (not subsiding with scratching, which prompts repeated scratching; severe). Nighttime pruritus was rated on a five-grade scale: 0 (absent), 1 (slight itching at bedtime but not causing intentional scratching; no difficulty sleeping because of pruritus), 2 (slight itching that subsides with scratching; no difficulty sleeping because of pruritus), 3 (difficulty sleeping because of pruritus that resolves with scratching; unconscious scratching occurs during sleep), or 4 (severe difficulty sleeping due to pruritus; frequent scratching that worsens pruritus). A negative change from baseline indicates improvement. | The enrolled population with available data at each time point | Posted | Mean | Standard Deviation | units on a scale | Baseline and weeks 2, 16, and 32 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline | One target thumb nail or fingernail representing the worst nail psoriasis involvement was selected for assessment at Baseline. The nail matrix was assessed for presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling) graded on a scale of 0 (none) to 4 (present in all 4 quadrants). The nail bed was assessed for the presence of any nail bed features (onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma) on a scale from 0 (none) to 4 (present in all quadrants). The sum of the nail matrix and nail bed scores is the total score and ranges from 0 to 8 (worst). | The enrolled population with Baseline NAPSI Score ≥ 1; missing data were imputed using non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 16 and 32 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32 | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much), except for Question 7, which first asks whether the participant's skin prevented them from working or studying (Yes (score = 3) or No (score = 0), then If "No", the participant is asked how much their skin was a problem at work or studying over the last week, with responses from 0 (not at all), 1 (a little), or 2 (a lot). The DLQI total score ranges from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A negative change from baseline indicates improvement. | The enrolled population with available data at each time point | Posted | Mean | Standard Deviation | scores on a scale | Baseline and weeks 16 and 32 |
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| Secondary | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32 | The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement. | The enrolled population with available data at each time point | Posted | Mean | Standard Deviation | percent change | Baseline and weeks 16 and 32 |
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| Secondary | Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75) | The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. | The enrolled population; missing values were imputed using non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 16 and 32 |
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| Secondary | Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50) | The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. | The enrolled population; missing data was imputed using non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 16 and 32 |
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| Secondary | Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores | The Treatment Satisfaction Questionnaire for Medication (TSQM) version II is a self-administered instrument to understand a participant's satisfaction on current therapy. The TSQM comprises 11 items across 4 domains focusing on effectiveness (Item 1 and 2), side effects (Item 4 to 6), convenience (Item 7 to 9), and global satisfaction (Item 10 and 11). With the exception of Item 3 (experience any side effects; yes or no), all items have five or seven responses. Item scores are summed to give four domain scores, which are in turn transformed to a scale from 0 (extremely dissatisfied) to 100 (extremely satisfied). | The enrolled population with available data at each time point | Posted | Mean | Standard Deviation | scores on a scale | Baseline and weeks 16 and 32 |
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| Secondary | Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32 | The Patient Benefit Index (PBI) is used to assess patient-relevant benefits of psoriasis treatment as a function of the most important needs identified by the participant before the start of treatment. Participants were asked to assess the benefits of treatment by completing the Patient Benefit Questionnaire (PBQ), which consists of 25 treatment goal statements scored from 0 (not at all) to 4 (very). The PBI is calculated for each participant by weighing the achievement values of each statement by their importance to the individual patient as assessed prior to the start of treatment. The PBI ranges from 0 (no benefit) to 4 (maximum benefit). | The enrolled population; missing data was imputed using non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 16 and 32 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | The Investigator assessed the severity/intensity of each adverse event as: Mild (asymptomatic or mild symptoms; intervention not indicated; activities of daily life (ADLs) minimally or not affected); Moderate (symptom(s) cause moderate discomfort; local or noninvasive intervention indicated; more than minimal interference with ADLs but able to carry out daily social and functional activities; drug therapy may be required); Severe (symptoms causing severe discomfort/pain; symptoms requiring medical/surgical attention/intervention; interference with ADLs including inability to perform daily social and functional activities; drug therapy required). A serious adverse event is any AE occurring at any dose that:
| The safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug until at least 28 days after last dose; up to 36 weeks. |
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From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Not provided
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 | Apremilast 30 mg | Participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16, participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician. | 0 | 152 | 4 | 152 | 84 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Faeces soft | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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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 | Apr 30, 2020 | Dec 20, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C505730 | apremilast |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
| ≥ 75 years |
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| 2 (Mild) |
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| 3 (Moderate) |
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| 4 (Severe) |
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| 2 (Mild) |
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| 3 (Moderate) |
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| 4 (Severe) |
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