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A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT04527380
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis [JoAS]) and juvenile psoriatic arthritis (JPsA).

Condition or disease Intervention/treatment Phase
Juvenile Psoriatic Arthritis Enthesitis Related Arthritis Drug: Ixekizumab Drug: Adalimumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : March 17, 2023
Estimated Study Completion Date : February 10, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ixekizumab
Ixekizumab given subcutaneously (SC).
 Drug: Ixekizumab
Administered SC
Other Name: LY2439821
Active Comparator: Adalimumab
Adalimumab given SC. Participants may have the option to switch to ixekizumab given SC during the open label extension period.
 Drug: Adalimumab
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 [ Time Frame: Week 16 ]
    Percentage of Participants Achieving JIA ACR 30


Secondary Outcome Measures :
  1. Percentage of Participants Achieving JIA ACR 30/50/70/90/100 [ Time Frame: Week 0 up to Week 104 ]
    Percentage of Participants Achieving JIA ACR 30/50/70/90/100

  2. Change from Baseline in Psoriasis Area and Severity Index (PASI) for JPsA Participants with at Least 3% Body Surface Area (BSA) at Baseline [ Time Frame: Baseline, up to Week 104 ]
    Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline

  3. Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline [ Time Frame: Baseline, up to Week 104 ]
    Change from Baseline in LEI for Participants with Enthesitis at Baseline

  4. Percentage of Participants with Disease Flare (Flare Defined as Worsening of ≥30% from Baseline in at Least 3 of the 6 JIA ACR Core Set Criteria and an Improvement of ≥30% in No More than 1 of the Criteria) [ Time Frame: Week 0 up to Week 104 ]
    Percentage of Participants with Disease Flare (Flare Defined as Worsening of ≥30% from Baseline in at Least 3 of the 6 JIA ACR Core Set Criteria and an Improvement of ≥30% in No More than 1 of the Criteria)

  5. Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab [ Time Frame: Week 16 ]
    Pharmacokinetics (PK): Ctrough of Ixekizumab

  6. Number of Participants with Anti-Ixekizumab Antibodies [ Time Frame: Week 0 up to Week 104 ]
    Number of Participants with Anti-Ixekizumab Antibodies


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have active juvenile idiopathic arthritis (categories of enthesitis related arthritis or juvenile psoriatic arthritis)
  • Participants must have weight of at least 10 kilograms (Kg), age starting at 2 years for participants with juvenile psoriatic arthritis and starting at 6 years for participants with enthesitis related arthritis
  • Participants must have all immunizations up-to-date in agreement with current immunization guidelines, in the opinion of the investigator

Exclusion Criteria:

  • Participants must not have active or history of inflammatory bowel disease
  • Participants must not have active uveitis
  • Participants must not have active or latent tuberculosis
  • Participants must not have an active infection
  • Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis
Contacts and Locations
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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): NCT04527380


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04527380    
Other Study ID Numbers: 16694
I1F-MC-RHCG ( Other Identifier: Eli Lilly and Company )
2018-000681-10 ( EudraCT Number )
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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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
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Arthritis, Juvenile
Enthesopathy
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
 Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tendinopathy
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Adalimumab
Ixekizumab
Anti-Inflammatory Agents
Antirheumatic Agents