An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis

Phase 1

• Conditions: Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis; MedDRA version: 23.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-000681-10-NL
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified