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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

Primary Purpose

Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ixekizumab
Adalimumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Psoriatic Arthritis

Eligibility Criteria

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

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

Sites / Locations

  • Aarhus Universitetshospital, SkejbyRecruiting
  • Praxis Kinder- und Jugendrheumatologie Dr. Ivan FoeldvariRecruiting
  • CITER Centro de Investigación y Tratamiento de las Enfermedades ReumáticasRecruiting
  • Crea de GuadalajaraRecruiting
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"Recruiting
  • Medical Care and Research SA de CVRecruiting
  • Investigacion y Biomedicina de ChihuahuaRecruiting
  • Hospital Materno InfantilRecruiting
  • Haywood Community HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ixekizumab

Adalimumab

Arm Description

Ixekizumab given subcutaneously (SC).

Adalimumab given SC. Participants may have the option to switch to ixekizumab given SC during the open label extension period.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30
Percentage of Participants Achieving JIA ACR 30

Secondary Outcome Measures

Percentage of Participants Achieving JIA ACR 30/50/70/90/100
Percentage of Participants Achieving JIA ACR 30/50/70/90/100
Change from Baseline in Psoriasis Area and Severity Index (PASI) for JPsA Participants with at Least 3% Body Surface Area (BSA) at Baseline
Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline
Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline
Change from Baseline in LEI for Participants with Enthesitis at Baseline
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)
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)
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab
Pharmacokinetics (PK): Ctrough of Ixekizumab
Number of Participants with Anti-Ixekizumab Antibodies
Number of Participants with Anti-Ixekizumab Antibodies

Full Information

First Posted
August 24, 2020
Last Updated
October 10, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04527380
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
February 19, 2024 (Anticipated)
Study Completion Date
April 24, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ixekizumab
Arm Type
Experimental
Arm Description
Ixekizumab given subcutaneously (SC).
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
Adalimumab given SC. Participants may have the option to switch to ixekizumab given SC during the open label extension period.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab
Other Intervention Name(s)
LY2439821
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30
Description
Percentage of Participants Achieving JIA ACR 30
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving JIA ACR 30/50/70/90/100
Description
Percentage of Participants Achieving JIA ACR 30/50/70/90/100
Time Frame
Week 0 up to Week 264
Title
Change from Baseline in Psoriasis Area and Severity Index (PASI) for JPsA Participants with at Least 3% Body Surface Area (BSA) at Baseline
Description
Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline
Time Frame
Baseline, up to Week 264
Title
Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline
Description
Change from Baseline in LEI for Participants with Enthesitis at Baseline
Time Frame
Baseline, up to Week 264
Title
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)
Description
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
Title
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab
Description
Pharmacokinetics (PK): Ctrough of Ixekizumab
Time Frame
Week 16
Title
Number of Participants with Anti-Ixekizumab Antibodies
Description
Number of Participants with Anti-Ixekizumab Antibodies
Time Frame
Week 0 up to Week 264

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
clinicaltrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mia Glerup
Facility Name
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Foeldvari
Facility Name
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
5555334180
First Name & Middle Initial & Last Name & Degree
IVON KARINA RUIZ LOPEZ
Facility Name
Crea de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Vega Cornejo
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadina Rubio Perez
Facility Name
Medical Care and Research SA de CV
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Alejandro Barrera Rodríguez
Facility Name
Investigacion y Biomedicina de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Francisco Pacheco-Tena
Facility Name
Hospital Materno Infantil
City
Toluca
ZIP/Postal Code
50010
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samara Mendieta Zerón
Facility Name
Haywood Community Hospital
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Packham

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/4meAjhM5fQH03TtSGo4Knd
Description
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

Learn more about this trial

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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