A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

Systemic Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088396
• Other study ID #: 16275
• Secondary ID: I4V-MC-JAHU2017-
• Status: Recruiting
• Phase: Phase 3
• Start date: February 12, 2020
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years.

• Participants must have at least 2 active joints at screening and baseline.

• To be eligible for cohort 1, patients must be IL-6 inhibitor therapy naïve, have a minimum body weight of 10 kg and be at least 2 years old.

• To be eligible for cohort 2 (open-label baricitinib), patients must be at least 1 year old.

Exclusion Criteria:

• Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis.

• Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria.

• Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA.

• Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis.

• Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study.

• Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks.

• Participants must not have a current or recent (<4 weeks prior to baseline) clinically serious infection.

• Participants must not have a positive test for hepatitis B virus.

• Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Systemic Juvenile Idiopathic Arthritis

Intervention

Drug:
• Baricitinib
Administered orally
• Tocilizumab
Administered SC

Locations

Country	Name	City	State
Argentina	Hospital General de Niños Dr. Pedro de Elizalde	Buenos Aires
Argentina	Instituto CAICI SRL	Rosario	Santa Fe
Argentina	Centro Medico Privado de Reumatologia	SAN M. DE Tucuman	Tucumán
Austria	Medizinische Universität Wien	Vienna	Wien
Belgium	Cliniques universitaires Saint-Luc	Brussels	Bruxelles-Capitale, Région De
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Brazil	Faculdade de Medicina da UNESP	Botucatu	São Paulo
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	IPPMG - Biblioteca Asdrubal Costa	Rio de Janeiro
Brazil	Instituto da Crianca do Hospital das Clinicas da FMUSP	Sao Paulo	São Paulo
Brazil	IPITEC	São Paulo
Brazil	Universidade Federal de Sao Paulo	São Paulo
Czechia	Detska nemocnice FN Brno	Brno	Brno-mesto
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Denmark	Aarhus Universitetshospital, Skejby	Aarhus	Midtjylland
France	Hospices Civils de Lyon - Hôpital Femme Mère Enfant	Bron	Rhône-Alpes
France	Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre	Le Kremlin-Bicêtre	Paris
France	Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau	Nîmes	Gard
France	Hôpital Universitaire Necker Enfants Malades	Paris
France	Centre Hospitalier Universitaire de Poitiers	Poitiers	Vienne
India	Sri Ramachandra MedicaL College & Research Institute	Chennai	Tamil Nadu
India	Sanjay Gandhi Post Graduate Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Christian Medical College Vellore	Vellore	Tamil Nadu
Israel	Meir Medical Center	Kfar Saba	HaMerkaz
Israel	Schneider Children's Medical Center	Petah Tikva	HaMerkaz
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti	Chieti
Italy	IRCCS Istituto Giannina Gaslini	Genova	Liguria
Italy	Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO	Milano	Lombardia
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	University of Naples Federico II	Napoli	Campania
Italy	Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli	Palermo	Sicilia
Italy	Ospedale Infantile Burlo Garofolo	Trieste
Japan	Tokyo Medical And Dental University Medical Hospital	Bunkyo	Tokyo
Japan	Chiba Children's Hospital	Chiba
Japan	Kagoshima University Hospital	Kagoshima
Japan	Miyagi Children's Hospital	Sendai	Miyagi
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki	Osaka
Japan	Kanagawa Children's Medical Center	Yokohama	Kanagawa
Japan	Yokohama City University Hospital	Yokohama	Kanagawa
Mexico	Investigacion y Biomedicina de Chihuahua	Chihuahua
Mexico	Instituto de Investigaciones Clínicas para la Salud	Durango
Mexico	Crea de Guadalajara	Guadalajara	Jalisco
Mexico	Clinstile, S.A. de C.V.	Mexico	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Poland	Wojewódzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie	Krakow	Malopolskie
Poland	Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lódz	Lódzkie
Poland	Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji	Warsaw	Mazowieckie
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona [Barcelona]
Spain	Hospital Infantil Universitario Niño Jesús	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	València
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine	Istanbul
Turkey	9 Eylul University Hospital	Izmir
United Kingdom	Bristol Royal Hospital for Children	Bristol	Bristol, City Of
United Kingdom	Alder Hey Children's Hospital	Liverpool	England
United Kingdom	Great Ormond Street Hospital For Children NHS Foundation Trust	London	Camden
United Kingdom	Oxford University Hospitals - Nuffield Orthopaedic Centre	Oxford	Oxfordshire
United Kingdom	Sheffield Children's Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  Czechia,  Denmark,  France,  India,  Israel,  Italy,  Japan,  Mexico,  Poland,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12	Percentage of Participants Achieving Adapted PediACR30 Response Criteria	Week 12
Secondary	Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24	Percentage of Participants Achieving Adapted PediACR30 Response Criteria	Week 24
Secondary	Percentage of Participants with Inactive Disease	Percentage of Participants with Inactive Disease	Week 12
Secondary	Percentage of Participants with Minimal Disease Activity	Percentage of Participants with Minimal Disease Activity	Week 12
Secondary	Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27	Change from Baseline in JADAS-27	Baseline, Week 24
Secondary	Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item	Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item	Baseline, Week 24
Secondary	Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)	PK: Cmax, ss of Baricitinib	Baseline through Week 24
Secondary	PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)	PK: AUC, ss of Baricitinib	Baseline through Week 24

External Links

•   A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA