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The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast | Experimental | Apremilast will be dosed by participant's body weight and administered twice daily (BID) in the form of oral tablets, approximately 12 hours apart, without restriction of food or drink. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Oral tablet |
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|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Day 1 up to approximately 285 days |
| Measure | Description | Time Frame |
|---|---|---|
| Growth and Development as Assessed by Height | Day 1 up to approximately 285 days | |
| Growth and Development as Assessed by Weight | Day 1 up to approximately 285 days | |
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Inclusion Criteria:
Exclusion Criteria:
Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
Psoriasis flare or rebound within 4 weeks prior to screening.
Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
History of recurrent significant infections.
Active infection or infection treated with antibiotic treatment within 14 days of Study Day 1.
Any history of or active malignancy or myeloproliferative or lymphoproliferative disease.
Current use of the following therapies that may have a possible effect on psoriasis:
Conventional systemic therapy for psoriasis within 28 days prior to Study Day 1 (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters).
Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 28 days prior to Study Day 1.
Biologic therapy:
Use of tanning booths or other ultraviolet light sources.
Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during screening or at Study Day 1.
Female participant of childbearing potential with a positive pregnancy test assessed at screening and/or Study Day 1 by a serum and/or urine pregnancy test.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Affiliated Dermatology |
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| 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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| Growth and Development as Assessed by Body Mass Index (BMI) |
| Day 1 up to approximately 285 days |
| Columbia-Suicide Severity rating Scale (C-SSRS) | Day 1 to Day 225 |
| Tanner Staging of Sexual Maturity | Day 1 and Day 225 |
| Number of Participants With Psoriasis Flare | Up to approximately 285 days |
| Number of Participants With Psoriasis Rebound | Up to approximately 285 days |
| Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries | Day 1 to Day 225 |
| Number of Participants with Clinically Significant Changes in Laboratory Parameters | Up to approximately 225 days |
| Number of Participants with Clinically Significant Changes in Vital Signs | Up to approximately 285 days |
| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Clear Dermatology | Scottsdale | Arizona | 85255 | United States |
| Johnson Dermatology Clinic | Fort Smith | Arkansas | 72916 | United States |
| Avance Clinical Trials | Laguna Niguel | California | 92677 | United States |
| University of California Irvine | Orange | California | 92868 | United States |
| MedDerm Associates | San Diego | California | 92103 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| California Dermatology Institute | Thousand Oaks | California | 91320 | United States |
| Pediatric Skin Research LLC | Coral Gables | Florida | 33146 | United States |
| Ciocca Dermatology | Miami | Florida | 33173 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Endeavor Health Clinical Trials Center | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Southern Indiana Clinical Trials | New Albany | Indiana | 47150 | United States |
| Great Lakes Research Group Inc- Sheffield | Bay City | Michigan | 48706 | United States |
| Henry Ford Medical Center - New Center One | Detroit | Michigan | 48202 | United States |
| Dermatology and Skin Cancer Center of Lees Summit | Lee's Summit | Missouri | 64064 | United States |
| Boeson Research | Missoula | Montana | 59804 | United States |
| Empire Dermatology | East Syracuse | New York | 13057 | United States |
| State University of New York, Downstate Medical Center | Manhasset | New York | 11030 | United States |
| OptiSkin Medical | New York | New York | 10029 | United States |
| Hightower Clinical LLC | Oklahoma City | Oklahoma | 73120 | United States |
| Dermatology Research Center of Oklahoma, PLLC | Tulsa | Oklahoma | 74132 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Studies in Dermatology LLC | Cypress | Texas | 77429 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |
| Stride Clinical Research LLC | Sugar Land | Texas | 77479 | United States |
| Frontier Derm Partners | Mill Creek | Washington | 98012 | United States |
| ID | Term |
|---|---|
| C505730 | apremilast |
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