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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 March 2021
Main ID:  NCT04527380
Date of registration: 24/08/2020
Prospective Registration: Yes
Primary sponsor: Eli Lilly and Company
Public 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
Scientific 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
Date of first enrolment: February 26, 2021
Target sample size: 100
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04527380
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Argentina Belgium Czechia Denmark France Germany Italy Mexico
Netherlands Spain Switzerland United Kingdom
Contacts
Name:     There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address: 
Telephone: 1-317-615-4559
Email: clinicaltrials.gov@lilly.com
Affiliation: 
Name:     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)
Address: 
Telephone:
Email:
Affiliation:  Eli Lilly and Company
Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All
Health Condition(s) or Problem(s) studied
Enthesitis Related Arthritis
Juvenile Psoriatic Arthritis
Intervention(s)
Drug: Adalimumab
Drug: Ixekizumab
Primary Outcome(s)
Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 [Time Frame: Week 16]
Secondary Outcome(s)
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 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]
Number of Participants with Anti-Ixekizumab Antibodies [Time Frame: Week 0 up to Week 104]
Percentage of Participants Achieving JIA ACR 30/50/70/90/100 [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) [Time Frame: Week 0 up to Week 104]
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab [Time Frame: Week 16]
Secondary ID(s)
16694
2018-000681-10
I1F-MC-RHCG
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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