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Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

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ClinicalTrials.gov Identifier: NCT04804553
Recruitment Status : Not yet recruiting
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

Condition or disease Intervention/treatment Phase
Active Juvenile Psoriatic Arthritis Drug: Apremilast Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants will be randomized to receive apremilast or placebo in the double-blind 16 week treatment phase. Then, the participants will all receive apremilast for a further 36 weeks in the active treatment phase. The participants will then complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)
Estimated Study Start Date : July 27, 2021
Estimated Primary Completion Date : November 15, 2024
Estimated Study Completion Date : August 25, 2025


Arm Intervention/treatment
Experimental: Apremilast
Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.
Drug: Apremilast
Participants will receive apremilast orally.
Other Name: Otezla®

Placebo Comparator: Placebo to Apremilast
Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.
Drug: Apremilast
Participants will receive apremilast orally.
Other Name: Otezla®

Drug: Placebo
Participants will receive the matching placebo orally.




Primary Outcome Measures :
  1. Number of Participants who Achieve American College of Rheumatology Pediatric (ACR Pedi) 30 Response at Week 16 [ Time Frame: Week 16 ]

    The ACR Pedi 30 is defined as a minimum of 30% improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by > 30%.

    The ACR Pedi consists of 6 core criteria:

    1. physician global assessment (PGA) of disease activity (visual analog scale [VAS]) where 0 represents no disease activity and 100 represents the most disease activity
    2. participant/parent/guardian assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
    3. functional ability (assessed using the Childhood Health Assessment Questionnaire [CHAQ]) completed by the participant/parent/guardian;
    4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both)
    5. number of joints with limited range of motion
    6. laboratory marker of inflammation (C-reactive protein [CRP]).


Secondary Outcome Measures :
  1. Change from Baseline in Participants Assessment of Pain at Week 16 [ Time Frame: Baseline to Week 16 ]
    The participants assessment of pain will be assessed using a visual analogue scale (VAS). Participants will be asked to place a vertical line on a 100-mm VAS where the left-hand boundary represents "no pain" and the right-hand boundary represents "worst possible pain".

  2. Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16 [ Time Frame: Baseline and Week 16 ]

    The ACR Pedi 20, 50, 70 and 90 is defined as a minimum of either 20%, 50%. 70% or 90% improvement respectively from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >20%, >50%, >70% or >90% respectively.

    The ACR Pedi consists of 6 core criteria:

    1. PGA of disease activity (VAS) where 0 represents no disease activity and 100 represents the most disease activity
    2. participant/parent/guardian assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
    3. functional ability (assessed using the CHAQ) completed by the participant/parent/guardian
    4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion

    6. laboratory marker of inflammation (CRP).


  3. Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16 [ Time Frame: Baseline to Week 16 ]
    PGA of disease activity is assessed using a visual analog scale (VAS), where 0 represents no disease activity and 100 represents the most disease activity.

  4. Change from Baseline in the Assessment of Overall Well-being at Week 16 [ Time Frame: Baseline to Week 16 ]
    Assessment of overall well-being is assessed using a visual analog scale (VAS), where 0 represents very well and 100 represents very poor for overall well-being. This assessment can be completed be either the participant or the parent/guardian.

  5. Change from Baseline in the Number of Joints with Active Arthritis at Week 16 [ Time Frame: Baseline to Week 16 ]
    Active arthritis is defined as joints with swelling not caused by deformity of joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both.

  6. Change from Baseline in the Number of Joints with Limited Range of Motion at Week 16 [ Time Frame: Baseline to Week 16 ]
  7. Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16 [ Time Frame: Baseline to Week 16 ]
  8. Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16 [ Time Frame: Baseline to Week 16 ]
    The CHAQ will be used to assess physical ability and functional status of participants as well as their quality of life.

  9. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16 [ Time Frame: Baseline to Week 16 ]
    JADAS is a composite score of participant well-being visual analog scale (VAS) score, physician global assessment (PGA) VAS score, active joint count, and laboratory marker of inflammation (C-reactive protein [CRP]).

  10. Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16 [ Time Frame: Week 16 ]
    PsA flares are defined as more than or equal to 30% worsening in at least 3 of 6 American College of Rheumatology Pediatric (ACR Pedi) core set variables with a more than or equal to 30% improvement in not more than 1 of 6 ACR Pedi core set variables.

  11. Psoriasis Area Severity Index (PASI)-75 Response at Week 16 for Participants With a Baseline Psoriasis Body Surface Area (BSA) ≥ 3% [ Time Frame: Baseline and Week 16 ]
    PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.

  12. Number of Participants who Experience One or More Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 56 ]
  13. Number of Participants who Experience One or More Serious Treatment-emergent Adverse Events [ Time Frame: Up to Week 56 ]
  14. Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 3 Adverse Events [ Time Frame: Up to Week 56 ]
  15. Number of Participants who Experience One or More Treatment-Related Adverse Events [ Time Frame: Up to Week 56 ]
  16. Number of Participants who Experience Clinically Significant Laboratory Tests [ Time Frame: Up to Week 56 ]
  17. Number of Participants who Experience Clinically Significant Vital Sign Measurements [ Time Frame: Up to Week 56 ]
  18. Number of Participants who Experience Clinically Significant Physical Examination Measurements [ Time Frame: Up to Week 56 ]
  19. Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to Week 56 ]

    The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior is defined as the number of participants who answer "yes" at any time during the study (up to end of safety follow-up, Week 56) to one of the 10 categories:

    Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide


  20. Change from Baseline in Tanner Staging at Week 52 [ Time Frame: Baseline to Week 52 ]
    Tanner Staging of sexual development assessment will be used to assess sexual maturity. Tanner Staging assessment consists of 3 domains (pubic hair, breast development, and other changes) for girls and 4 domains (pubic hair, penis development, testes development, and other changes) for boys. Stages range from 1-5, with 1 indicating preadolescent and 5 adult.

  21. Change from Baseline in Body Weight at Week 56 [ Time Frame: Baseline to Week 56 ]
  22. Change from Baseline in Height at Week 56 [ Time Frame: Baseline to Week 56 ]
  23. Change from Baseline in Body Mass Index (BMI) at Week 56 [ Time Frame: Baseline to Week 56 ]
  24. Plasma Concentrations of Apremilast [ Time Frame: Week 2: 0-5 hours post dose; Week 8: 2 hours post dose; Week 16: 4 hours post-dose; Week 28: pre dose; Week 40: pre dose; Week 52: pre dose ]
  25. Taste and Acceptability of Apremilast [ Time Frame: Baseline and Week 2 ]
    Taste and acceptability will be assessed using a questionnaire with a 7-point faces Likert Scale, with 1 ranging from "super bad" to 7 "super good" and questions to determine whether the participants are able to take the treatment medication.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female participants 5 to < 18 years of age at the time of randomization.
  • Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:

    • Arthritis and psoriasis, OR
    • Arthritis with at least 2 of the following:
    • Dactylitis
    • Nail pitting or onycholysis
    • Psoriasis in a first-degree relative
  • Active disease: at least 3 active joints (including distal interphalangeal joints).
  • Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).

Exclusion Criteria:

  • Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:

    • Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
    • Ankylosing spondylitis, enthesitis-related arthritis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
    • History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
    • Presence of systemic juvenile idiopathic arthritis (JIA).
  • Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
  • Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804553


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04804553    
Other Study ID Numbers: 20190529
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Amgen:
Apremilast
Otezla®
Juvenile psoriatic arthritis
Inflammatory disorders
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents