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

March 18, 2024 updated by: Eli Lilly and Company

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinicaltrials.gov@lilly.com

Study Locations

  • Belgium
    • Bruxelles-Capitale, Région De
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
  • Denmark
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Aarhus Universitetshospital, Skejby
  • Germany
      • Berlin, Germany, 13125
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany, 13353
        • Charité Campus Virchow-Klinikum
      • Bremen, Germany, 28177
        • Klinikum Bremen-Mitte
      • Hamburg, Germany, 22081
        • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Universitaetsklinikum Freiburg
    • Nordrhein-Westfalen
      • Sankt Augustin, Nordrhein-Westfalen, Germany, 53757
        • Asklepios Klinik Sankt Augustin
      • Sendenhorst, Nordrhein-Westfalen, Germany, 48324
        • St. Josef-Stift Sendenhorst
  • Italy
      • Brescia, Italy, 25123
        • Azienda Ospedaliera Spedali Civili di Brescia
    • Campania
      • Napoli, Campania, Italy, 80131
        • University of Naples Federico II
    • Liguria
      • Genova, Liguria, Italy, 16147
        • IRCCS Istituto Giannina Gaslini
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milano, Lombardia, Italy, 20122
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • A.O.Universitaria Meyer
  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 06700
        • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
  • Netherlands
      • Utrecht, Netherlands, 3584 EA
        • UMC Utrecht - Wilhelmina Kinderziekenhuis
  • Spain
      • Malaga, Spain, 29011
        • H.R.U Málaga - Hospital Materno-infantil
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
      • València, Spain, 46026
        • Hospital Universitari I Politecnic La Fe
    • Barcelona [Barcelona]
      • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
        • Hospital Sant Joan de Deu
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28009
        • Hospital Infantil Universitario Niño Jesús
  • Switzerland
      • Sankt Gallen, Switzerland, 9006
        • Ostschweizer Kinderspital
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Universitäts-Kinderspital beider Basel
  • United Kingdom
      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Children's Hospital
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Children
    • England
      • Liverpool, England, United Kingdom, L14 5AB
        • Alder Hey Children's Hospital
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Queen's Medical Centre, Nottingham University Hospitals
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7HE
        • Oxford University Hospitals - Nuffield Orthopaedic Centre
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST6 7AG
        • Haywood Community Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ixekizumab
Ixekizumab given subcutaneously (SC).
Drug: Ixekizumab
Administered SC
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab
Time Frame: Week 16
Pharmacokinetics (PK): Ctrough of Ixekizumab
Week 16
Percentage of Participants Achieving JIA ACR 30/50/70/90/100
Time Frame: Week 0 up to Week 264
Percentage of Participants Achieving JIA ACR 30/50/70/90/100
Week 0 up to Week 264
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 264
Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline
Baseline, up to Week 264
Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline
Time Frame: Baseline, up to Week 264
Change from Baseline in LEI for Participants with Enthesitis at Baseline
Baseline, up to Week 264
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 264
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)
Week 0 up to Week 264
Number of Participants with Anti-Ixekizumab Antibodies
Time Frame: Week 0 up to Week 264
Number of Participants with Anti-Ixekizumab Antibodies
Week 0 up to Week 264

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Actual)

February 19, 2024

Study Completion (Estimated)

April 24, 2028

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16694
  • I1F-MC-RHCG (Other Identifier: Eli Lilly and Company)
  • 2018-000681-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Juvenile Psoriatic Arthritis

Clinical Trials on Ixekizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe