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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000681-10-NL

Enrollment

100

Registered

2021-01-07

Start date

2021-04-16

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) Product Name: Taltz (80 mg solution for injection in pre-filled syringe) Pharmaceutical Form: Solution for injection in pre-fille

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: 1. To evaluate the efficacy of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA based on the other clinical responses, disease activity and physical function measures 2. To evaluate the efficacy of adalimumab (reference arm) in children with JIA subtypes of ERA (including JoAS) and JPsA based on JIA ACR 30 and the other clinical responses, disease activity and physical function measures 3. To characterize ixekizumab pharmacokinetics (PK) in children with JIA subtypes of ERA (including JoAS) and JPsA 4. To evaluate the potential development of antiixekizumab antibodies and their impact on the efficacy and safety of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA 5. Describe the safety of ixekizumab in patients with JIA subtypes of ERA (including JoAS) and JPsA;Primary end point(s): Percentage of patients meeting the JIA ACR 30 response criteria at Week 16;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Main Objective: 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;Secondary Objective: 1. To evaluate the efficacy of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA based on the other clinical responses, disease activity and physical function measures 2. To evaluate the efficacy of adalimumab (reference arm) in children with JIA subtypes of ERA (including JoAS) and JPsA based on JIA ACR 30 and the other clinical responses, disease activity and physical function measures 3. To characterize ixekizumab pharmacokinetics (PK) in children with JIA subtypes of ERA (including JoAS) and JPsA 4. To evaluate the potential development of antiixekizumab antibodies and their impact on the efficacy and safety of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA 5. Describe the safety of ixekizumab in patients with JIA subtypes of ERA (including JoAS) and JPsA;Primary end point(s): Percentage of patients meeting the JIA ACR 30 response criteria at Week 16;Timepoint(s) of evaluation of this end point: Week 16

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Secondary

Measure	Time frame
Secondary end point(s): - 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);Timepoint(s) of evaluation of this end point: Secondary outcomes will be assessed at each regular study visit (every 3 months)	—

Measure

Time frame

Secondary end point(s): - 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);Timepoint(s) of evaluation of this end point: Secondary outcomes will be assessed at each regular study visit (every 3 months)

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Countries

Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026