I1F-MC-RHCG
Research type
Research Study
Full 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
IRAS ID
287451
Contact name
Harald Tietz
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-000681-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 25 days
Research summary
Juvenile idiopathic arthritis (JIA) is the most common type of arthritis in children. The term idiopathic
means “of unknown origin” There are six subtypes of JIA, this study will look at two of these
enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA).
The goal of JIA treatment is to reduce inflammation, control pain and improve quality of life. The
primary treatments in JIA include nonsteroidal anti-inflammatory drugs, intra-articular and systemic
corticosteroids, methotrexate, conventional disease modifying antirheumatic drugs (cDMARDs) and
biologic DMARDs. More than one medication can be used to treat JIA.
The medication ixekizumab is a monoclonal antibody that binds to IL-17A (a protein in the body)
which has been identified as playing a role in inflammation response to psoriatic arthritis (PsA) and
axial spondyloarthritis axSpA. Both ERA and JPsA are similar to adult PsA and axSpA and it is hoped
ixekizumab will have a therapeutic benefit.
Globally, ixekizumab has been approved for the treatment of plaque psoriasis and psoriatic arthritis
(PsA) in adults. For paediatrics ixekizumab is approved for use in plaque psoriasis from the age of 6
years old. In the United States ixekizumab has been approved for the treatment of radiographic
axial spondyloarthritis (r-axSpA).
I1F-MC-RHCG study will look at the efficacy, safety, tolerability of ixekizumab as well as how it moves
within the body in patients with JIA subtypes. Based on its well-established efficacy and safety
profile in JIA, Adalimumab will be used as a reference arm. To take part in this study patients must
be at least 2 to less than 18 years of age. Participation in the study will be about 31 months. About
100 patients will be taking part including approximately 23 in the UK.REC name
East Midlands - Derby Research Ethics Committee
REC reference
20/EM/0224
Date of REC Opinion
24 Nov 2020
REC opinion
Further Information Favourable Opinion