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

• Register: EUCTR
• Last refreshed on: 11 November 2024
• Main ID: EUCTR2018-000681-10-IT
• Date of registration: 24/05/2021
• Prospective Registration: No
• Primary sponsor: ELI LILLY & COMPANY, LILLY CORPORATE CENTER
• Public title: An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis
• Scientific 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 - TALZ
• Date of first enrolment: 23/12/2020
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000681-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion 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:
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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis

Intervention(s)

Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
Product Name: Ixekizumab
Product Code: [TALTZ]
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ixekizumab
Current Sponsor code: LY243921
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-

Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Current Sponsor code: HUMIRA
Concentration unit: 1X 100 milligrams/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Week 16

Primary end point(s): Percentage of patients meeting the JIA ACR 30 response criteria at Week 16

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

Secondary Outcome(s)

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)

Secondary ID(s)

I1F-MC-RHCG

2018-000681-10-FR

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 23/11/2020
Contact: