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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 | Clinical Trials | Clareo Health

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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

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

NCT04527380•Eli Lilly and Company

View on ClinicalTrials.gov

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).

Eligibility

Age

2 - 17 years

Sex

ALL

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

Locations (43)

Instituto CAICI SRL Loc. 15

Rosario, Santa Fe Province, Argentina

Centro Medico Privado de Reumatologia Loc. 20

San Miguel de Tucumán, Tucumán Province, Argentina

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Oddeleni revmatologie deti a dospelych Loc. 1

Prague, Praha 5, Czechia

Dětská klinika Loc. 11

Olomouc, Czechia

Klinika detskeho a dorostoveho lekarstvi Loc. 1

Prague, Czechia

Aarhus Universitetshospital, Skejby

Aarhus, Central Jutland, Denmark

Service rhumatologie Loc.

Bron, Auvergne-Rhône-Alpes, France

Key Dates

Start Date

April 13, 2021

Primary Completion Date

February 19, 2024

Completion Date

April 1, 2028

Last Updated

March 19, 2026

Enrollment

101

ACTUAL participants

Conditions

Juvenile Psoriatic ArthritisEnthesitis Related Arthritis

Interventions

Ixekizumab

DRUG

Adalimumab

DRUG

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

NCT06100744

Juvenile Psoriatic Arthritis

View study

RECRUITING

The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis

NCT06383195

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis

Transition to Adulthood Through Coaching and Empowerment in Rheumatology