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Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03701763
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE October 10, 2018
Last Update Posted Date April 17, 2020
Actual Study Start Date  ICMJE December 3, 2018
Estimated Primary Completion Date October 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline [ Time Frame: Up to week 16 ]
The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Proportion of subjects who achieve at least a 75% reduction in PASI (PASI-75) from baseline [ Time Frame: Up to week 16 ]
    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 is a validated instrument that has become standard in clinical trials for psoriasis.
  • Proportion of subjects who achieve at least a 50% reduction in PASI (PASI-50) from baseline [ Time Frame: Up to week 16 ]
    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 is a validated instrument that has become standard in clinical trials for psoriasis.
  • Percent change from baseline in total PASI score [ Time Frame: Up to week 16 ]
    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 is a validated instrument that has become standard in clinical trials for psoriasis.
  • Percent change from baseline in affected Body Surface Area (BSA) [ Time Frame: Up to week 16 ]
    BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand, which equates to approximately 1% of total body surface area.
  • Proportion of subjects who achieve CDLQI (0/1) [ Time Frame: Up to week 16 ]
    The CDLQI is designed to measure the impact of skin disease on children's quality of life.
  • Change from baseline in CDLQI score [ Time Frame: Up to week 16 ]
    The CDLQI is designed to measure the impact of skin disease on children's quality of life.
  • Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    Number of subjects with adverse event
  • Stool Diary [ Time Frame: From Baseline up to week 56 ]
    Symptoms of bowel movement will be collected using a daily stool diary
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: From Baseline up to Week 52 ]
    Questionnaire designed to determine any risk of self-harm by the study subject
  • Tanner Stages [ Time Frame: At Baseline and week 52 ]
    Tanner Stages is a scale defining physical measurements of sexual development based on external primary and secondary sex characteristics
  • Psoriasis disease flare [ Time Frame: From Baseline up to week 52 ]
    Proportion of subjects with sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications
  • Psoriasis Rebound [ Time Frame: 4 week follow-up, 8 week follow-up, and 14 week follow-up visits ]
    Severe and sudden worsening of disease (PASI ≥ 125% of baseline or new generalized, pustular, erythrodermic psoriasis) after treatment has been discontinued
  • Height Measurement [ Time Frame: Up to week 66 ]
    Height is measured and recorded at each visit
  • Weight Measurement [ Time Frame: Up to week 66 ]
    Weight is measured and recorded at each visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Brief Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.

At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

Detailed Description Treatment will be assigned by weight with subjects 20 kg to < 50 kg receiving apremilast 20 mg BID or placebo BID and subjects ≥ 50 kg receiving apremilast 30 mg BID or placebo BID. Total study duration is up to 71 weeks. Subjects completing all 52 weeks of the treatment and extension phase will be able to enter the Long-term study. Subjects not entering the Long-term study will return for 3 observational follow-up visits, 4, 8 and 14 weeks after last dose of study drug.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Apremilast (CC-10004)
    Apremilast (CC-10004)
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Administration of Apremilast (CC-10004) - 20mg
    Apremilast 20mg Twice Daily (BID)
    Intervention: Drug: Apremilast (CC-10004)
  • Experimental: Administration of Apremilast (CC-10004) - 30mg
    Apremilast 30mg Twice Daily (BID)
    Intervention: Drug: Apremilast (CC-10004)
  • Placebo Comparator: Administration of Placebo
    Placebo tablet Twice Daily (BID)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 19, 2022
Estimated Primary Completion Date October 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian
  2. Subjects must have a weight of ≥ 20 kg
  3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
  4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:

    • PASI score ≥ 12; and
    • Body surface area (BSA) ≥ 10%; and
    • sPGA ≥ 3 (moderate to severe)
  5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
  6. Candidate for systemic therapy or phototherapy

Exclusion Criteria:

  1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
  2. Psoriasis flare or rebound within 4 weeks prior to Screening
  3. Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
  4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline
  5. Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis

    a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol)

    Exceptions*:

    i. Low potency or weak corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae and groin in accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions

    *Subjects should not use these topical treatments within 24 hours prior to the clinic visit.

    b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   France,   Germany,   Israel,   Italy,   Netherlands,   Russian Federation,   Spain,   United States
Removed Location Countries Hungary,   Mexico
 
Administrative Information
NCT Number  ICMJE NCT03701763
Other Study ID Numbers  ICMJE CC-10004-PPSO-003
U1111-1219-3112 ( Registry Identifier: WHO )
2018-002918-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
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.
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.
URL: http://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP