Clinical trial • Phase III • Immunology|Endocrinology

BARICITINIB for Type 1 diabetes

Phase III trial of BARICITINIB for Type 1 diabetes. Randomised, placebo to match ly (placebo matching baricitinib); dose/schedule not specified-controlled.

Overview

Trial Therapeutic Area
Immunology|Endocrinology
Trial Disease
Type 1 diabetes
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
28-08-2025
First CTIS Authorization Date
23-12-2025

Trial design

Randomised, placebo to match ly (placebo matching baricitinib); dose/schedule not specified-controlled Phase III trial in Belgium, Finland, France and others.

Randomised
Yes
Comparator
Placebo to match LY (placebo matching baricitinib); dose/schedule not specified
Target Sample Size
58
Trial Duration For Participant
1825

Eligibility

Recruits 58 paediatric patients.

Vulnerable Population
Vulnerable populations are selected (isVulnerablePopulationSelected = true). The trial includes children and adolescents (full title: participants aged ≥1 to <36 years). Age-appropriate informed consent and assent documents are provided: parental/legal guardian informed consent forms for minors, separate Main Parent/Parental ICFs, and multiple assent/consent forms for children and adolescents (examples in documents: Assent 5 to 11y; Assent 7-11yo; Assent 11-17yo; Adolescent Consent 15-17 yr; Adolescent Assent 12-14 yr; Younger Child Assent). Language- and country-specific ICF/assent versions are provided for participating countries.

Inclusion criteria

  • {"criterion_text":"- Have at least two diabetes-related autoantibodies in their history, AND have two diabetes-related autoantibodies at screening or prescreening"}
  • {"criterion_text":"- Be at risk for type 1 diabetes (have Stage 1b or Stage 2)"}
  • {"criterion_text":"- Weigh at least 8 kilograms (kg) (18 pounds) at screening"}

Exclusion criteria

  • {"criterion_text":"- Have diabetes (Stage 3)"}
  • {"criterion_text":"- Have uncontrolled high blood pressure"}
  • {"criterion_text":"- Have had a heart attack, heart disease, stroke, or heart failure"}
  • {"criterion_text":"- Have a history or high risk of blood clots or certain types of cancer"}
  • {"criterion_text":"- Have a current or recent serious infection"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes [Time Frame: Baseline up to approximately 5 years]","definition_or_measurement_approach":"Defined as time from baseline to diagnosis of Stage 3 Type 1 Diabetes, measured from baseline up to approximately 5 years."}

Recruitment

Planned Sample Size
58
Recruitment Window Months
65
Consent Approach
Informed consent provided by adult participants; for minors parental/legal guardian consent is required. Age-appropriate assent and consent forms are provided (examples: Main ICF; ICF for parents and guardians; Assent forms for younger children and older children/adolescents; Adolescent consent 15-17 yrs). Multiple language and country-specific ICF/assent versions are supplied (documents list includes versions in English, French, Portuguese, Spanish, Dutch, Swedish, Polish, Italian, Finnish, Norwegian and country-specific/local language variants).

Methods

  • Use of recruitment materials (brochures, flyers, posters, clinical-trial brochures) targeted to children/young people (CYP) and to parents/caregivers (K2 recruitment materials available in multiple languages and country-specific versions).
  • Site-based recruitment through participating hospitals/diabetes centres (site contact details provided per country).
  • Study-specific recruitment procedures and informed consent process documented in K1 "Informed consent and Patient Recruitment Procedure" and K1/K2 recruitment arrangements documents (country-specific K1/K2 files).
  • Printed materials for schools and families (school notes, visit-cards, passport-stickers) and participant-facing brochures/certificates used for outreach and retention (country-specific).

Geography

Total Number Of Sites
48
Total Number Of Participants
97

Belgium

Earliest CTIS Part Ii Submission Date
24-11-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
46
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
UZ Leuven
Department Name
Endocrinology
Contact Person Name
Chantal Mathieu
Contact Person Email
chantal.mathieu@uzleuven.be
Site Name
Antwerp University Hospital
Department Name
Endocrinology Diabetology Metabolism
Contact Person Name
Christophe De Block
Contact Person Email
christophe.deblock@uza.be
Site Name
Cliniques Universitaries Saint Luc
Department Name
Pediatric Endocrinology
Contact Person Name
Philippe Lysy
Contact Person Email
philippe.lysy@uclouvain.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Pediatrics
Contact Person Name
Dominique Beckers
Site Name
UZ Brussel
Department Name
Pediatrics
Contact Person Name
Willem Staels
Contact Person Email
willem.staels@uzbrussel.be

Finland

Earliest CTIS Part Ii Submission Date
24-11-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
29
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Pohjois-Pohjanmaan hyvinvointialue
Department Name
Department of Pediatrics
Contact Person Name
Riitta Veijola
Contact Person Email
riitta.veijola@oulu.fi
Site Name
Varsinais-Suomen hyvinvointialue
Department Name
Pediatrics
Contact Person Name
Jorma Toppari
Contact Person Email
jortop@utu.fi
Site Name
Tampere University Hospital
Department Name
Pediatric Early Phase Trials Unit
Contact Person Name
Sauli Palmu
Contact Person Email
sauli.palmu@tuni.f

France

Earliest CTIS Part Ii Submission Date
08-12-2025
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
16
Number Of Sites
9
Number Of Participants
10

Sites

Site Name
Hospices Civils de Lyon – Hôpital Louis Pradel
Department Name
Centre d’Investigation Clinique
Contact Person Name
Marc NICOLINO
Contact Person Email
marc.nicolino@chu-lyon.fr
Site Name
CHU Rangueil
Department Name
Diabétologie, maladies métaboliques et nutrition
Contact Person Name
Pierre GOURDY
Contact Person Email
gourdy.p@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Diabétologie Nutrition
Contact Person Name
Anne VAMBERGUE
Contact Person Email
anne.vambergue@chu-lille.fr
Site Name
Pitié Salpêtrière University Hospital
Department Name
Service de Diabétologie
Contact Person Name
Chloé AMOUYAL
Contact Person Email
chloe.amouyal@aphp.fr
Site Name
Robert Debre University Hospital
Department Name
Centre d'Investigations Cliniques
Contact Person Name
Elise BISMUTH
Contact Person Email
elise.bismuth@aphp.fr
Site Name
Centre Hospitalier Sud Francilien
Department Name
Endocrino diabétologie
Contact Person Name
Alfred Endocrino diabétologie PENFORNIS
Contact Person Email
alfred.penfornis@chsf.fr
Site Name
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Department Name
Pediatrie multidisciplinaire -Endocrinologie
Contact Person Name
Rachel REYNAUD
Contact Person Email
rachel.reynaud@ap-hm.fr
Site Name
Hopital Necker Enfants Malades
Department Name
Centre d'Investigation Clinique
Contact Person Name
Alix BESANCON
Contact Person Email
alix.besancon@aphp.fr
Site Name
Hôpitaux Universitaires Paris Centre-Hôpital Cochin
Department Name
Service de Diabétologie
Contact Person Name
Roberto MALLONE
Contact Person Email
roberto.mallone@inserm.fr

Germany

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
14
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Hannoversche Kinderheilanstalt
Department Name
Kinder- und Jugendkrankenhaus AUF DER BULT, Diabetes- und Endokrinologiezentrum
Contact Person Name
Olga Kordonouri
Contact Person Email
kordonouri@hka.de
Site Name
TUM Klinikum
Department Name
Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universitaet Muenchen
Contact Person Name
Anette Gabriele Ziegler
Site Name
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Department Name
Klinik und Poliklinik fuer Kinder- und Jugendmedizin - Studienzentrum
Contact Person Name
Gita Gemulla
Contact Person Email
gita.gemulla@ukdd.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Klinik fuer Kinder- und Jugendmedizin
Contact Person Name
Desiree Dunstheimer

Portugal

Earliest CTIS Part Ii Submission Date
04-11-2025
Latest Decision Or Authorization Date
29-12-2025
Processing Time Days
55
Number Of Sites
5
Number Of Participants
2

Sites

Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Endocrinology
Contact Person Name
Marta Ferreira
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Endocrinology
Contact Person Name
Rosa Maria Príncipe
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Pediatric endocrinology and diabetology
Contact Person Name
Ana Sofia Martins
Contact Person Email
sofiacgam@gmail.com
Site Name
Unidade Local De Saude Do Alto Minho E.P.E.
Department Name
Diabetology
Contact Person Name
Maria Cristina Roque
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Pediatric
Contact Person Name
Teresa Borges
Contact Person Email
emaildateresa@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
05-11-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
64
Number Of Sites
10
Number Of Participants
14

Sites

Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Pediatria
Contact Person Name
Ivana Rabbone
Contact Person Email
ivana.rabbone@uniupo.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Pediatria B
Contact Person Name
Claudio Maffeis
Contact Person Email
claudio.maffeis@univr.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
SOC Diabetologia ed Endocrinologia
Contact Person Name
Lorenzo Lenzi
Contact Person Email
lr.lenzi@meyer.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dept. of Medical and Surgical sciences
Contact Person Name
Guido Di Dalmazi
Contact Person Email
guido.didalmazi@unibo.it
Site Name
Azienda Ospedaliera di Padova
Department Name
UOSD Diabetologia Pediatrica e Malattie Metaboliche dell'Età Evolutiva
Contact Person Name
Carlo Moretti
Contact Person Email
carlo.moretti@aopd.veneto.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department Name
S.O.D. DIABETOLOGIA PEDIATRICA, Dipartimento Materno-Infantile
Contact Person Name
Valentino Cherubini
Contact Person Email
valentino.cherubini@gmail.com
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO Medicina Generale a indirizzo Diabetologico e Endocrino-Metabolico
Contact Person Name
Emanuele Bosi
Contact Person Email
bosi.emanuele@hsr.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Diabetologia pediatrica
Contact Person Name
Enza Mozzillo
Contact Person Email
mozzilloenza@gmail.com
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Department of Clinical Medicine and Surgery
Contact Person Name
Lutgarda Bozzetto
Contact Person Email
lutgarda.bozzetto@unina.it
Site Name
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
Department Name
SSD Diabetologia Pediatrica
Contact Person Name
Carlo Ripoli
Contact Person Email
carlo.ripoli@aob.it

Poland

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
40
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Medical Network Sp. z o.o.
Contact Person Name
Edyta Jablonska-Wypustek
Contact Person Email
ejablonska@poczta.onet.pl

Spain

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
02-01-2026
Processing Time Days
70
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Endocrinología y Nutrición
Contact Person Name
Lía Nattero Chávez
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Endocrinología Pedíatrica
Contact Person Name
Roque Cardona-Hernandez
Contact Person Email
roque.cardona@sjd.es
Site Name
Hospital Universitario De Cruces
Department Name
Endocrinología Pediátrica
Contact Person Name
Nancy Elizabeth Portillo Najera

Norway

Earliest CTIS Part Ii Submission Date
10-12-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
13
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Helse Stavanger HF
Department Name
Department of Research
Contact Person Name
Sondre Meling
Contact Person Email
sondre.vatne.meling@sus.no
Site Name
Akershus University Hospital
Department Name
Dept. of Paediatric and Adolescent Medicine
Contact Person Name
Christopher Inchley
Contact Person Email
inchley@ahus.no
Site Name
Oslo University Hospital HF
Department Name
Dept. Endocrinology, morbid obesity and preventive medicine
Contact Person Name
Kari Anne Sveen
Contact Person Email
kasvee@ous-hf.no
Site Name
Oslo University Hospital HF
Department Name
Unit for endocrinology and diabetes, Division for Paeditric and Adolescent Medicine
Contact Person Name
Lars Krogvold
Contact Person Email
Lars.krogvold@gmail.com
Site Name
Helse Bergen HF
Department Name
Pediatric department
Contact Person Name
Henrik Underthun Irgens

Sweden

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
62
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Skåne university Hospital
Department Name
Department of Pediatrics
Contact Person Name
Helena Elding Larsson
Site Name
Region Oerebro Laen
Department Name
Department of Pediatrics
Contact Person Name
Frida Sundberg
Contact Person Email
frida.sundberg@oru.se

Netherlands

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
48
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Diabeter Nederland B.V.
Department Name
Pediatrician-Diabetologist
Contact Person Name
Hendrik Jan Aanstoot
Contact Person Email
h.j.aanstoot@diabeter.nl

Sponsor

Primary sponsor

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

Contract research organisations

Name
Labcorp Central Laboratory Services LP
Responsibilities
Laboratory services (sponsorDuties code: 4)
Name
Iqvia Biotech LLC
Responsibilities
Study development/conduct and site selection (Study Developent/Conduct - Site Selection; sponsorDuties codes: 15/1/4)
Name
Bioclinica Inc.
Responsibilities
Study development/conduct related tasks (sponsorDuties code: 4)
Name
Altasciences Compagnie Inc.
Responsibilities
Study development/conduct related tasks (sponsorDuties code: 4)
Name
Medidata Solutions Inc.
Responsibilities
Services indicated by sponsorDuties code: 7
Name
RWS Life Sciences Inc.
Responsibilities
Support services indicated by sponsorDuties code: 6
Name
Greenphire LLC
Responsibilities
Patient screening, recruitment, and/or retention (Study Development/Conduct - Patient Screening, Recruitement, and/or Retention)

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Study Developent/Conduct - Site Selection","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Study Development/Conduct - Patient Screening, Recruitement, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
BARICITINIB
Active Substance
BARICITINIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (product present with productDictionaryInfo and SmPC document referenced)
Maximum Dose
4 mg per day
Investigational Product Name
Baricitinib (ORAL SUSPENSION)
Active Substance
BARICITINIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (productDictionaryInfo prodAuthStatus available)
Maximum Dose
4 mg per day
Investigational Product Name
Placebo to match LY
Modality
Other

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