A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)

• Register: EUCTR
• Last refreshed on: 27 May 2024
• Main ID: EUCTR2017-004471-31-BE
• Date of registration: 06/05/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)
• Scientific title: A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA)
• Date of first enrolment: 09/08/2019
• Target sample size: 217
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004471-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Czechia, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Turkey, United Kingdom

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
- Have either completed participation in or terminated early from Study JAHV or Study JAHU and have not completed Post Treatment Follow up in those studies.
- Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent (if applicable) and consent, respectively, according to local guidelines.
- Male or nonpregnant, nonbreastfeeding female patients. Patients of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle).Otherwise, patients and their partners of childbearing potential must agree to use 2 effective methods of contraception.
Are the trial subjects under 18? yes
Number of subjects for this age range: 410
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:
- Had investigational product permanently discontinued in the originating study
- Had temporary investigational product interruption at the final study visit of the originating study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the current study
Medical Conditions
- Have a known hypersensitivity to baricitinib or any component of this investigational product
- Active anterior uveitis or receiving concurrent treatment for anterior uveitis
- Have significant uncontrolled cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that developed during the originator study that, in the opinion of the investigator, could constitute an unacceptable risk to the patient if investigational product continues
- Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol
- Intends to donate blood during the course of the study
- Intend to receive a live vaccine (except booster immunization with attenuated vaccine for measles, mumps, and rubella [MMR] or varicella-zoster virus [VZV]) during the course of the study, or up to 28 days after the last dose of study drug. Booster vaccination for MMR or VZV may be considered if it is essential based on the local guideline and/or in the opinion of the investigator.
- Currently enrolled in any other clinical study (except the originating study at screening for the current study) involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study



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

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis
MedDRA version: 23.1 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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

Intervention(s)

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Suspension for oral suspension
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Primary end point(s): - Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
- Temporary investigational product interruptions and permanent investigational product discontinuations
- Vital signs, growth and development, and laboratory evaluations (including chemistry and hematology)

Main Objective: The primary objective of this protocol is to evaluate the long-term safety and tolerability of baricitinib in patients with JIA or sJIA

Secondary Objective: The secondary objectives of the study are
-to evaluate the long-term efficacy of baricitinib in children with JIA or sJIA
-to assess the long-term efficacy of baricitinib in children with JPsA
-to evaluate the long-term efficacy of baricitinib in children with ERA or JPsA
-to evaluate the potential effects of baricitinib on the cellular and humoral immune system

Timepoint(s) of evaluation of this end point: through Week 264

Secondary Outcome(s)

Secondary end point(s): Through Week 264:
- Proportion of patients who achieve PedACR30/50/70/90/100 response rates using baseline of the originator study
- Proportion of patients who demonstrate durability of PedACR30/50/70/90/100 response rates from the time of randomization in the originator study.
- Proportion of patients who maintain PedACR30/50/70/90/100 response rates from baseline of the current study.
- Proportion of patients who have disease flare.
- Time to disease flare.
- Changes from baseline in each of the 6 individual components of the PedACR core set values of the originator study
- Change from baseline in the Physical Summary Score (PhS) and Psychosocial Summary Score (PsS) of the originator study of the Child Health Questionnaire-Parent Form 50 (CHQ-PF50)
- Change from baseline of the originator study in caregiver burden as measured by the Parental Impact-Time and Parental Impact-Emotion scales of the CHQ-PF50
- Proportion of patients with inactive disease (as defined by Wallace et al 2011).
- Proportion of patients with minimal disease activity (as defined by Consolaro et al 2012).
- Proportion of patients in remission (as defined by Wallace et al 2012)
- Change from baseline of originating study in Juvenile Arthritis Disease Activity Score-27 (JADAS27).
- Change from baseline of originating study in arthritis-related pain severity, as measured by the CHAQ pain severity Visual Analogue Scale (VAS) item.
In patients with JPsA:
- Change from baseline of originating study in Psoriasis Area and Severity Index (PASI)
In patients with ERA or JPsA:
- Change from baseline of originating study in SPARCC enthesis index
- Change from baseline of originating study in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
- Change from baseline of originating study in immunoglobulin levels and peripheral blood immunophenotyping (including T and B cells, T cell subsets, and NK cells)
- Change of IgG titers from pre-vaccination to 4 weeks and 12 weeks post vaccination in patients eligible for vaccination with tetanus, diphtheria, and pertussis (TDaP) and/or pneumococcal according to local guidelines.

Timepoint(s) of evaluation of this end point: through Week 264

Secondary ID(s)

2017-004471-31-DK

I4V-MC-JAHX

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 09/08/2019
Contact: