Clinical trial • Phase III • Immunology|Rare Disease

BARICITINIB for Systemic juvenile idiopathic arthritis

Phase III trial of BARICITINIB for Systemic juvenile idiopathic arthritis.

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Systemic juvenile idiopathic arthritis
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
17-01-2024
First CTIS Authorization Date
20-02-2024

Trial design

Randomised, open-label, tocilizumab (reference arm) - solution for injection, subcutaneous injection (tocilizumab as reference comparator is listed); placebo arms described as matching formulations (placebo to match 4 mg tablet; placebo to match 2 mg/ml oral suspension; placebo to match 2 mg tablet; placebo to match 1 mg tablet). specific doses and schedules are not stated in the ctis data provided.-controlled Phase III trial in Belgium, Poland, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Tocilizumab (reference arm) - solution for injection, subcutaneous injection (Tocilizumab as reference comparator is listed); Placebo arms described as matching formulations (Placebo to match 4 mg tablet; Placebo to match 2 mg/mL oral suspension; Placebo to match 2 mg tablet; Placebo to match 1 mg tablet). Specific doses and schedules are not stated in the CTIS data provided.
Target Sample Size
49

Eligibility

Recruits 49 paediatric patients.

Vulnerable Population
Children aged 1 to <18 years are included; vulnerable population selected. Consent is to be provided by parents/legal representatives and age-appropriate assent is required from participating children (multiple age-specific assent forms and parent/legal guardian ICFs are provided, including separate documents for younger and older children and for PK/PoC cohorts). Subject information and consent/assent materials are available in multiple language versions (e.g. English, French, Dutch, Polish, Italian, Spanish, Czech as indicated by document translations).

Inclusion criteria

  • {"criterion_text":"- Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) with onset before the age of 16 years."}
  • {"criterion_text":"- Participants must have arthritis in a joint and fever lasting 2 weeks, with daily fever for 3 days, and at least 1 of the following: Evanescent erythematous rash, generalized lymph node enlargement, enlarged liver/spleen, serositis."}
  • {"criterion_text":"- Participants must have at least 2 active joints."}

Exclusion criteria

  • {"criterion_text":"- Participants must not have polyarticular JIA, extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis."}
  • {"criterion_text":"- Participants must not have persistent oligoarticular arthritis."}
  • {"criterion_text":"- Participants must not have any autoimmune inflammatory condition other than JIA."}
  • {"criterion_text":"- Participants must not have active anterior uveitis."}
  • {"criterion_text":"- Participants must not have active fibromyalgia or other chronic pain conditions."}
  • {"criterion_text":"- Participants must not have an infection."}
  • {"criterion_text":"- Participants must not have an infection."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 (PediACR30) Response Criteria at Week 12","definition_or_measurement_approach":"Adapted PediACR30 response criteria assessed at Week 12; endpoint measured as the percentage of participants achieving the adapted PediACR30 at Week 12."}

Recruitment

Registry Or Advocacy Recruitment
True, Pediatric Rheumatology International Trials Organisation
Planned Sample Size
49
Recruitment Window Months
64
Consent Approach
Informed consent is obtained from parents/legal representatives; assent is obtained from children using age-appropriate assent forms. Multiple consent/assent documents exist (L1 SIS and ICF for Child, Younger Child, Older Child; Parent ICFs; Assent forms for different age bands; addenda for PK/PoC cohorts). Documents are provided in multiple languages (examples include English, French, Dutch, Polish, Italian, Spanish, Czech as indicated by available translations and document versions).

Geography

Total Number Of Sites
29
Total Number Of Participants
30

Belgium

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
18-12-2024
Processing Time Days
322
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology oncology pediatric
Contact Person Name
Cecile Boulanger
Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatric rheumatology
Contact Person Name
Joke Dehoorne
Contact Person Email
joke.dehoorne@uzgent.be
Site Name
UZ Leuven
Department Name
Kinderreumatologie
Contact Person Name
Lien De Somer
Contact Person Email
lien.desomer@uzleuven.be

Poland

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
315
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji, Klinika Reumatologii Wieku Rozwojowego
Department Name
Hospital
Contact Person Name
Piotr Gietka
Contact Person Email
piotr.gietka@spartanska.pl
Site Name
CSK, Uniwersyteckie Centrum Pediatrii im. M.Konopnickiej
Department Name
Hospital
Contact Person Name
Elzbieta Smolewska
Contact Person Email
e.smolewska@wp.pl
Site Name
Szpital Dzieciecy Sw. Ludwika III Oddział Kliniczny Pediatrii Reumatologii z pododdziałem alergologi
Department Name
Hospital
Contact Person Name
Zbigniew Zuber
Contact Person Email
zbyszekzuber@interia.pl

Czechia

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
25-03-2025
Processing Time Days
419
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
University Hospital Olomouc
Department Name
reumatology
Contact Person Name
Kateřina Bouchalová
Contact Person Email
katerina.bouchalova@fnol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
reumatology
Contact Person Name
Marcel Schüller
Contact Person Email
schullerm@email.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
reumatology
Contact Person Name
Pavla Doležalová
Contact Person Email
pavla.dolezalova@vfn.cz

France

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
759
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Rhumatologie
Contact Person Name
Elisabeth Gervais
Site Name
Bicetre Hospital
Department Name
Rhumatologie pediatrique et CEREMAIA
Contact Person Name
Isabelle Kone-Paut
Contact Person Email
isabelle.kone-paut@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service de pédiatrie
Contact Person Name
Tu-Anh Tran
Contact Person Email
tu.anh.tran@chu-nimes.fr
Site Name
Hospices Civils De Lyon
Department Name
Service Rhumatologie
Contact Person Name
Alexandre Belot
Contact Person Email
alexandre.belot@chu-lyon.fr
Site Name
Hopital Necker Enfants Malades
Department Name
Centre d'Investigation Clinique
Contact Person Name
Pierre Quartier-Dit-Maire
Contact Person Email
pierre.quartier@aphp.fr

Austria

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
12-05-2025
Processing Time Days
467
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Department Name
Universitätsklinik für Kinder- und Jugendheilkunde
Contact Person Name
Wolfgang Emminger

Italy

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
726
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dipartimento Scienze Mediche Traslazionali
Contact Person Name
Maria Alessio
Contact Person Email
mariolina.alessio@gmail.com
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Clinica Pediatrica
Contact Person Name
Alberto Tommasini
Site Name
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Contact Person Name
Achille Marino
Site Name
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Department Name
Pediatria ad indirizzo reumatologico
Contact Person Name
Luciana Breda
Contact Person Email
luciana.bredach@gmail.com
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Clinica Pediatrica
Contact Person Name
Marco Cattalini
Contact Person Email
marco.cattalini@unibs.it
Site Name
Giannina Gaslini Institute For Scientific Hospitalization And Care
Department Name
Clinica Pediatrica e Reumatologia
Contact Person Name
Roberta Caorsi
Contact Person Email
robertacaorsi@gaslini.org
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
Pediatria
Contact Person Name
Maria Cristina Maggio
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Pediatria media intensità di cura
Contact Person Name
Giovanni Filocamo

Spain

Earliest CTIS Part Ii Submission Date
31-01-2024
Latest Decision Or Authorization Date
08-04-2025
Processing Time Days
433
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Sant Joan De Deu Barcelona Hospital
Department Name
Pediatric Rheumatology
Contact Person Name
Jordi Anton
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Pediatric Inmunology
Contact Person Name
Marisol Camacho Lovillo
Contact Person Email
marisolcl73@gmail.com
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric Rheumatology
Contact Person Name
Daniel Clemente
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Pediatric Rheumatology
Contact Person Name
Alina Lucica Boteanu
Contact Person Email
al_boter@yahoo.com
Site Name
Hospital Universitario La Paz
Department Name
Pediatric Rheumatology
Contact Person Name
Rosa Alcobendas
Contact Person Email
rosaalcobendasrueda@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric Rheumatology
Contact Person Name
Lucia Lacruz Perez
Contact Person Email
lacruz_lucper@gva.es

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Fortrea Inc.
Responsibilities
sponsorDuties codes: [10]
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [6]
Name
IQVIA RDS (India) Private Limited
Responsibilities
sponsorDuties codes: [4]
Name
Labcorp Central Laboratory Services LP
Responsibilities
sponsorDuties codes: [4]
Name
Altasciences Compagnie Inc.
Responsibilities
sponsorDuties codes: [4]
Name
Signant Health LLC
Responsibilities
sponsorDuties codes: [6]
Name
RWS Life Sciences Inc.
Responsibilities
sponsorDuties codes: [6]
Name
Macrostat (Shanghai) Clinical Research Co. Ltd.
Responsibilities
sponsorDuties codes: [10]
Name
Q Squared Solutions LLC
Responsibilities
sponsorDuties codes: [4]
Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties codes: [4]
Name
Iqvia Rds Inc.
Responsibilities
sponsorDuties codes: [1]

Third parties

  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Brightech International, LLC","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Adjudication (code 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"IQVIA RDS (India) Private Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Macrostat (Shanghai) Clinical Research Co. Ltd.","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Pediatric Rheumatology International Trials Organisation","duties_or_roles":"Patient Screening, Recruitment, and/or Retention (code 15)","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Baricitinib (oral suspension / tablet formulations)
Active Substance
BARICITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
1
Maximum Dose
4 mg (max daily)
Investigational Product Name
Tocilizumab (reference comparator)
Active Substance
TOCILIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
1|2
Maximum Dose
3888 mg (max total amount as listed)

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