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A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Apremilast
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Apremilast, Otezla, AMG 407, CC-10004, Pediatric, Plaque psoriasis

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must have a weight of ≥ 20 kg. Participant must have an age and sex specific BMI value no lower in range than the fifth percentile on the growth chart for children and adolescents. Participant is able to swallow the study medication tablet. Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening. Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by: Psoriasis Area Severity Index score 2-15, Body surface area 2-15%, and Static Physician Global Assessment score of 2-3 (mild to moderate) Disease inadequately controlled by or inappropriate for topical therapy for psoriasis. 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: Etanercept (or biosimilar) treatment 28 days prior to Study Day 1 Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1 Other TNF or IL-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) within 12 weeks prior to Study Day 1 Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to Study Day 1. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Apremilast

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Treatment-emergent Adverse Events

    Secondary Outcome Measures

    Growth and Development as Assessed by Height
    Growth and Development as Assessed by Weight
    Growth and Development as Assessed by Body Mass Index (BMI)
    Columbia-Suicide Severity rating Scale (C-SSRS)
    Tanner Staging of Sexual Maturity
    Number of Participants With Psoriasis Flare
    Number of Participants With Psoriasis Rebound
    Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries
    Number of Participants with Clinically Significant Changes in Laboratory Parameters
    Number of Participants with Clinically Significant Changes in Vital Signs

    Full Information

    First Posted
    October 12, 2023
    Last Updated
    October 12, 2023
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06088199
    Brief Title
    A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
    Official Title
    A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 3, 2023 (Anticipated)
    Primary Completion Date
    December 17, 2026 (Anticipated)
    Study Completion Date
    December 17, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plaque Psoriasis
    Keywords
    Apremilast, Otezla, AMG 407, CC-10004, Pediatric, Plaque psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Apremilast
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Apremilast
    Other Intervention Name(s)
    AMG 407, Otezla, CC-10004
    Intervention Description
    Oral tablet
    Primary Outcome Measure Information:
    Title
    Number of Participants With Treatment-emergent Adverse Events
    Time Frame
    Day 1 up to approximately 285 days
    Secondary Outcome Measure Information:
    Title
    Growth and Development as Assessed by Height
    Time Frame
    Day 1 up to approximately 285 days
    Title
    Growth and Development as Assessed by Weight
    Time Frame
    Day 1 up to approximately 285 days
    Title
    Growth and Development as Assessed by Body Mass Index (BMI)
    Time Frame
    Day 1 up to approximately 285 days
    Title
    Columbia-Suicide Severity rating Scale (C-SSRS)
    Time Frame
    Day 1 to Day 225
    Title
    Tanner Staging of Sexual Maturity
    Time Frame
    Day 1 and Day 225
    Title
    Number of Participants With Psoriasis Flare
    Time Frame
    Up to approximately 285 days
    Title
    Number of Participants With Psoriasis Rebound
    Time Frame
    Up to approximately 285 days
    Title
    Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries
    Time Frame
    Day 1 to Day 225
    Title
    Number of Participants with Clinically Significant Changes in Laboratory Parameters
    Time Frame
    Up to approximately 225 days
    Title
    Number of Participants with Clinically Significant Changes in Vital Signs
    Time Frame
    Up to approximately 285 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must have a weight of ≥ 20 kg. Participant must have an age and sex specific BMI value no lower in range than the fifth percentile on the growth chart for children and adolescents. Participant is able to swallow the study medication tablet. Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening. Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by: Psoriasis Area Severity Index score 2-15, Body surface area 2-15%, and Static Physician Global Assessment score of 2-3 (mild to moderate) Disease inadequately controlled by or inappropriate for topical therapy for psoriasis. 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: Etanercept (or biosimilar) treatment 28 days prior to Study Day 1 Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1 Other TNF or IL-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) within 12 weeks prior to Study Day 1 Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to Study Day 1. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amgen Call Center
    Phone
    866-572-6436
    Email
    medinfo@amgen.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
    IPD Sharing Time Frame
    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.
    IPD Sharing Access Criteria
    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.
    IPD Sharing URL
    http://www.amgen.com/datasharing
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

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