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

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Juvenile Psoriatic Arthritis; Enthesitis Related Arthritis

Treatments: Drug: Adalimumab; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04527380

16694

I1F-MC-RHCG (Other Identifier)

2018-000681-10 (EudraCT Number)

2023-507184-19-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Enrollment: 101 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Ixekizumab - OLT Period

Experimental group

Description:

Participants received subcutaneous (SC) ixekizumab from week 0 to week 16, following dosing regimens based on body weight: * Greater than (\>) 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC every 4 weeks (Q4W) from week 2 to week 16. * 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16. * 10.0 to less than (\<) 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.

Treatment:

Drug: Ixekizumab

Adalimumab - OLT Period

Active Comparator group

Description:

Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight: * Greater than or equal to (≥) 30.0 kg: 40 mg SC every 2 weeks (Q2W). * 10.0 to \<30.0 kg: 20 mg SC Q2W.

Treatment:

Drug: Adalimumab