This study has been transitioned to CTIS with ID 2023-507184-19-00 check the CTIS register for the current data. To evaluate the efficacy of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA based on the JIA American College…
ID
Source
Brief title
Condition
- Synovial and bursal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients meeting the JIA ACR 30 response criteria at Week 16
Secondary outcome
- Percentage of patients meeting the JIA ACR 30/50/70/90/100 response criteria
- Changes from baseline in each of the 6 individual components of the JIA ACR
core set variables
- Change from baseline in Psoriasis Area and Severity Index (PASI) for JPsA
patients with at least 3% Body Surface Area (BSA) at baseline
- Change from baseline in Leeds Enthesitis Index (LEI) for patients with
enthesitis at baseline
- Proportion of patients with disease flare (flare defined as worsening of >=30%
from baseline in at least 3 of the 6 JIA ACR core set criteria and an
improvement of >=30% in no more than 1 of the criteria)
- Trough concentrations of ixekizumab in patients with JIA subtypes of ERA
(including JoAS) and JPsA at Week 16
- Percentage of patients with anti-ixekizumab antibodies
- Adverse events (AEs) including serious adverse events (SAEs)
- Safety parameters including but not limited to infections, injection site
reactions, and laboratory data including B-, T-cell, and natural killer (NK)-
cell levels, white blood cell (WBC) count, red blood cell (RBC) count, alanine
aminotransferase (ALT), aspartate aminotransferase (AST)
Background summary
Ixekizumab has been approved for the treatment of plaque psoriasis and
psoriatic arthritis (PsA) worldwide, and for radiographic axial
spondyloarthritis (r-axSpA) in adults in the US. Enthesitis related arthritis
(ERA) and juvenile PsA (JPsA) bear resemblance to adult axSpA and PsA,
respectively; therefore, therapeutic benefit of ixekizumab is expected in these
2 subtypes of juvenile idiopathic arthritis (JIA). There are currently only 2
biologics, both tumor necrosis factor (TNF) inhibitors, adalimumab and
etanercept, approved for ERA, and only etanercept for JPsA, with certain age
limitations. Ixekizumab may offer a therapeutic option for ERA and JPsA
patients who are candidates for an initial biologic disease-modifying
antirheumatic drug
(bDMARD) therapy, as well as patients with primary or secondary efficacy
failure or intolerance of prior bDMARD. Based on its well-established efficacy
and safety profile in JIA, adalimumab was selected as a reference product. This
study is part of the European Paediatric Investigation
Plan (PIP), EMEA-001050-PIP02-18-M01, with the aim to evaluate the efficacy,
safety, tolerability, and pharmacokinetics (PK) of ixekizumab when administered
to pediatric patients with JIA subsets of ERA (including juvenile onset
ankylosing spondylitis [JoAS]) and JPsA.
Study objective
This study has been transitioned to CTIS with ID 2023-507184-19-00 check the CTIS register for the current data.
To evaluate the efficacy of ixekizumab in children with JIA subtypes of ERA
(including JoAS) and JPsA based on the JIA American College of
Rheumatology (ACR) 30 response
Study design
Study I1F-MC-RHCG (RHCG) is a multicenter, randomized, open-label study of
subcutaneous (SC) ixekizumab, with adalimumab as a reference arm, followed by
an open-label extension period with ixekizumab and adalimumab in children from
2 to less than 18 years of age with JIA subtypes of ERA (including JoAS) and
JPsA.
Intervention
Subjects will be randomized 1:1 to ixekizumab versus adalimumab. Both
ixekizumab and adalimumab will be administered subcutaneous. ixekizumab will
be injected once every 4 weeks and adalimumab once every 2 weeks. Dosing
concentrations will depend on the weight of the patient
Study burden and risks
Subject*s participation in this study will last 31 months and consists of a
screening period, open label treatment period, open label extension treatment
period and a follow-up period. During the open treatment periods, subjects will
need to visit the study site every 4 weeks. During the follow-up period,
subjects will need to visit the study site every 4 weeks for 3 times. Aside
from the intervention described above, participation in this study involves
blood draws at multiple visits. Participants will be subjected toIn addition to
section E6, subjects will be subjected to: questions regarding medical history,
use of concomitant medications/procedures and adverse events; urine sampling;
measurement of vital signs; physical examination; joint assessments; TB, HBV,
HIV and pregnancy test; X-ray; and patient reported outcomes questionnaires.
subjects will be expected to not take part in other medical studies, keep their
appointments for visits, follow instructions from the study team, keep a
patient card with them at all times, not donate blood/sperm/ova and to use
appropriate forms of contraception (if applicable).
Most common (>=1%) adverse reactions associated with ixekizumab treatment are
injection site reactions, upper respiratory tract infections, nausea, and tinea
infections. In clinical trials in adult patients with plaque psoriasis, the
ixekizumab group had a higher rate of infections than the placebo group (27%
vs. 23%). Upper respiratory tract infections, oral candidiasis, conjunctivitis
and tinea infections occurred more frequently in the ixekizumab group than in
the placebo group.
A similar increase in the risk of infection was seen in placebo-controlled
trials in patients with pediatric psoriasis, PsA and AS. Serious
hypersensitivity reactions, including angioedema and urticaria (each <=0.1%),
occurred in the ixekizumab group in clinical trials. Anaphylaxis,
including cases leading to hospitalization, has been reported in post marketing
use with ixekizumab.
Lilly Corporate Center, Delaware St 1526
Indianapolis 46285
US
Lilly Corporate Center, Delaware St 1526
Indianapolis 46285
US
Listed location countries
Age
Inclusion criteria
-Participants must have active juvenile idiopathic arthritis (categories of
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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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-507184-19-00 |
| EudraCT | EUCTR2018-000681-10-NL |
| ClinicalTrials.gov | NCT04527380 |
| CCMO | NL74998.056.20 |