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

Sponsor
Eli Lilly and Company
Study ID
NCT04527380
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Enthesitis Related Arthritis
  • Juvenile Psoriatic Arthritis

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Apr 13, 2021
Status verified
Mar 2026
Primary completion
Feb 19, 2024
Completion
Apr 30, 2028

Study Design

Enrollment
101 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ixekizumab - OLT Period
    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.
  • Active Comparator: Adalimumab - OLT Period
    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.

Primary Outcome Measure

Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period) [ Time Frame: Week 16 ]

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