Clinical trial • Phase III • Endocrinology
BARICITINIB for Type 1 diabetes
Phase III trial of BARICITINIB for Type 1 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 1 diabetes
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 26-09-2025
- First CTIS Authorization Date
- 02-02-2026
Trial design
Randomised, placebo to match ly (placebo) versus baricitinib (ly3009104). active product: baricitinib (oral film-coated tablet and oral suspension formulations). tablet formulation lists max daily dose amount 4 mg; oral suspension lists max daily dose amount 2 ml (sponsor product code ly3009104). specific schedule details not stated in the ctis metadata.-controlled Phase III trial in Belgium, Czechia, France and others.
- Randomised
- Yes
- Comparator
- Placebo to match LY (Placebo) versus Baricitinib (LY3009104). Active product: Baricitinib (oral film-coated tablet and oral suspension formulations). Tablet formulation lists max daily dose amount 4 mg; oral suspension lists max daily dose amount 2 ml (sponsor product code LY3009104). Specific schedule details not stated in the CTIS metadata.
- Target Sample Size
- 117
- Trial Duration For Participant
- 364
Eligibility
Recruits 117 paediatric patients.
- Vulnerable Population
- Paediatric population included (participants aged ≥1 to <36 years). The dossier includes age-appropriate assent and consent documents: parental/guardian informed consent, legal representative ICFs, and multiple assent forms for children/adolescents (e.g., Younger Child Assent, Older Child Assent, Assent 6-11, Assent 7-11, Assent 12-14, Assent 15-17). Materials and ICFs are provided for parents/guardians and for different child age groups and in multiple country/language versions (e.g., ENG, BEFR, BEDU, PL, FI, SE, NO), indicating processes for parental consent and child assent according to age.
Inclusion criteria
- {"criterion_text":"-Have a new diagnosis of type 1 diabetes\n-Have at least one protein in the blood (called an autoantibody) that is associated with diabetes at screening\n-Weigh at least 8 kilograms (18 pounds) at screening"}
Exclusion criteria
- {"criterion_text":"-Have any other type of diabetes\n-Have uncontrolled high blood pressure\n-Have had a heart attack, heart disease, stroke, or heart failure\n-Have a history or high risk of blood clots or certain types of cancer\n-Have a current or recent serious medical condition or infection"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Change from Baseline in C-peptide Area Under the Curve (AUC) [Time Frame: Baseline, Week 52]","definition_or_measurement_approach":"Change from baseline in C-peptide Area Under the Curve (AUC) measured at Baseline and Week 52 (C-peptide AUC over the specified time frame)."}
Recruitment
- Planned Sample Size
- 117
- Recruitment Window Months
- 28
- Consent Approach
- Informed consent process uses age- and role-specific documents: main ICF for adults, parental/legal representative ICFs for minors, and age-appropriate assent forms (several versions for younger children, older children, adolescents, and specific age bands such as 6-11, 12-14, 15-17). Documents are provided in multiple languages and country-specific versions (examples: ENG, BEFR, BEDU, PL, FI, SE, NO). Sponsor and site contacts are provided; consent/assent materials include supplemental information (e.g., future research addenda, DPA, instruction for use) and procedures for recruitment and informed consent are documented (K1/K2 and ICF document set).
Methods
- Site-led recruitment via participating hospitals/diabetes clinics and clinician referrals (listed trial sites and named clinical contacts across countries).
- Use of printed recruitment materials: brochures (parents/caregivers and CYP), flyers, posters, recruitment brochures specific to countries/languages (K2 Recruitment material files present for many MSCs).
- Patient-facing materials and retention materials: patient cards, visit cards, passport stickers, certificate of participation, study guides (documents listed under recruitment/materials).
- Letter of doctor referral (document listed).
- Country-specific recruitment arrangements documents and procedures (K1_Recruitment Arrangements and local K1/K2 files per country).
Geography
- Total Number Of Sites
- 71
- Total Number Of Participants
- 183
Belgium
- Earliest CTIS Part Ii Submission Date
- 22-01-2026
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 12
- Number Of Sites
- 9
- Number Of Participants
- 15
Sites
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Endocrinology-Diabetology-Metabolism
- Principal Investigator Name
- Christophe De Block
- Principal Investigator Email
- christophe.deblock@uza.be
- Contact Person Name
- Christophe De Block
- Contact Person Email
- christophe.deblock@uza.be
- Site Name
- Hopital Erasme
- Department Name
- Endocrinologie
- Principal Investigator Name
- Miriam Cnop
- Principal Investigator Email
- miriam.cnop@ulb.be
- Contact Person Name
- Miriam Cnop
- Contact Person Email
- miriam.cnop@ulb.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Pédiatrie
- Principal Investigator Name
- Dominique Beckers
- Principal Investigator Email
- dominique.beckers@chuuclnamur.uclouvain.be
- Contact Person Name
- Dominique Beckers
- Contact Person Email
- dominique.beckers@chuuclnamur.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Endocrinology
- Principal Investigator Name
- Chantal Mathieu
- Principal Investigator Email
- chantal.mathieu@uzleuven.be
- Contact Person Name
- Chantal Mathieu
- Contact Person Email
- chantal.mathieu@uzleuven.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Endocrinology
- Principal Investigator Name
- Dominique Beckers
- Principal Investigator Email
- dominique.beckers@chuuclnamur.uclouvain.be
- Contact Person Name
- Dominique Beckers
- Contact Person Email
- dominique.beckers@chuuclnamur.uclouvain.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- Philippe Lysy
- Principal Investigator Email
- philippe.lysy@uclouvain.be
- Contact Person Name
- Philippe Lysy
- Contact Person Email
- philippe.lysy@uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Endocrinologie
- Principal Investigator Name
- Imke Matthys
- Principal Investigator Email
- imke.matthys@uzgent.be
- Contact Person Name
- Imke Matthys
- Contact Person Email
- imke.matthys@uzgent.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Diabetes Nutrition and Metabolics disorders
- Principal Investigator Name
- jean-christophe philips
- Principal Investigator Email
- jcphilips@chuliege.be
- Contact Person Name
- jean-christophe philips
- Contact Person Email
- jcphilips@chuliege.be
- Site Name
- UZ Brussel
- Department Name
- Pediatrics
- Principal Investigator Name
- Willem Staels
- Principal Investigator Email
- willem.staels@uzbrussel.be
- Contact Person Name
- Willem Staels
- Contact Person Email
- willem.staels@uzbrussel.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 10-12-2025
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 55
- Number Of Sites
- 3
- Number Of Participants
- 13
Sites
- Site Name
- Nemocnice Jihlava prispevkova organizace
- Department Name
- Pediatricke oddeleni
- Principal Investigator Name
- Pavel Vlachy
- Principal Investigator Email
- vlachyp@nemji.cz
- Contact Person Name
- Pavel Vlachy
- Contact Person Email
- vlachyp@nemji.cz
- Site Name
- Milan Kvapil s.r.o.
- Principal Investigator Name
- Frantisek Loos
- Principal Investigator Email
- frankyloos@gmail.com
- Contact Person Name
- Frantisek Loos
- Contact Person Email
- frankyloos@gmail.com
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika detskeho lekarstvi
- Principal Investigator Name
- Jiri Strnadel
- Principal Investigator Email
- jiri.strnadel@fno.cz
- Contact Person Name
- Jiri Strnadel
- Contact Person Email
- jiri.strnadel@fno.cz
France
- Earliest CTIS Part Ii Submission Date
- 12-12-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 59
- Number Of Sites
- 9
- Number Of Participants
- 18
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Diabétologie Nutrition
- Principal Investigator Name
- Anne VAMBERGUE
- Principal Investigator Email
- anne.vambergue@chu-lille.fr
- Contact Person Name
- Anne VAMBERGUE
- Contact Person Email
- anne.vambergue@chu-lille.fr
- Site Name
- Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
- Department Name
- Pediatrie multidisciplinaire -Endocrinologie
- Principal Investigator Name
- Rachel REYNAUD
- Principal Investigator Email
- rachel.reynaud@ap-hm.fr
- Contact Person Name
- Rachel REYNAUD
- Contact Person Email
- rachel.reynaud@ap-hm.fr
- Site Name
- Hospices Civils de Lyon – Hôpital Louis Pradel
- Department Name
- Centre d’Investigation Clinique
- Principal Investigator Name
- Marc NICOLINO
- Principal Investigator Email
- marc.nicolino@chu-lyon.fr
- Contact Person Name
- Marc NICOLINO
- Contact Person Email
- marc.nicolino@chu-lyon.fr
- Site Name
- Pitié Salpêtrière University Hospital
- Department Name
- Service de Diabétologie
- Principal Investigator Name
- Chloé AMOUYAL
- Principal Investigator Email
- chloe.amouyal@aphp.fr
- Contact Person Name
- Chloé AMOUYAL
- Contact Person Email
- chloe.amouyal@aphp.fr
- Site Name
- Centre Hospitalier Sud Francilien
- Department Name
- Endocrino diabétologie
- Principal Investigator Name
- Alfred PENFORNIS
- Principal Investigator Email
- alfred.penfornis@chsf.fr
- Contact Person Name
- Alfred PENFORNIS
- Contact Person Email
- alfred.penfornis@chsf.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Diabétologie, maladies métaboliques et nutrition
- Principal Investigator Name
- Pierre GOURDY
- Principal Investigator Email
- gourdy.p@chu-toulouse.fr
- Contact Person Name
- Pierre GOURDY
- Contact Person Email
- gourdy.p@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire de Grenoble
- Department Name
- Service Endocrinologie Diabetologie Nutrition
- Principal Investigator Name
- Sandrine LABLANCHE
- Principal Investigator Email
- slablanche@chu-grenoble.fr
- Contact Person Name
- Sandrine LABLANCHE
- Contact Person Email
- slablanche@chu-grenoble.fr
- Site Name
- Hopital Necker Enfants Malades
- Department Name
- Centre d'Investigation Clinique
- Principal Investigator Name
- Alix BESANCON
- Principal Investigator Email
- alix.besancon@aphp.fr
- Contact Person Name
- Alix BESANCON
- Contact Person Email
- alix.besancon@aphp.fr
- Site Name
- Robert Debre University Hospital
- Department Name
- Centre d'Investigations Cliniques
- Principal Investigator Name
- Elise BISMUTH
- Principal Investigator Email
- elise.bismuth@aphp.fr
- Contact Person Name
- Elise BISMUTH
- Contact Person Email
- elise.bismuth@aphp.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 06-11-2025
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 89
- Number Of Sites
- 9
- Number Of Participants
- 14
Sites
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOC Malattie del Metabolismo
- Principal Investigator Name
- Federico Boscari
- Principal Investigator Email
- federico.boscari@gmail.com
- Contact Person Name
- Federico Boscari
- Contact Person Email
- federico.boscari@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Diabetologia pediatrica
- Principal Investigator Name
- Enza Mozzillo
- Principal Investigator Email
- enza.mozzillo@unina.it
- Contact Person Name
- Enza Mozzillo
- Contact Person Email
- enza.mozzillo@unina.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- Pediatria B
- Principal Investigator Name
- Claudio Maffeis
- Principal Investigator Email
- claudio.maffeis@univr.it
- 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
- Principal Investigator Name
- Barbara Piccini
- Principal Investigator Email
- barbara.piccini@meyer.it
- Contact Person Name
- Barbara Piccini
- Contact Person Email
- barbara.piccini@meyer.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Diabetologia
- Principal Investigator Name
- Ilaria Dicembrini
- Principal Investigator Email
- ilaria.dicembrini@unifi.it
- Contact Person Name
- Ilaria Dicembrini
- Contact Person Email
- ilaria.dicembrini@unifi.it
- Site Name
- Universita Degli Studi Di Messina
- Department Name
- DAI Materno Infantile
- Principal Investigator Name
- Fortunato Lombardo
- Principal Investigator Email
- fortunato.lombardo@unime.it
- Contact Person Name
- Fortunato Lombardo
- Contact Person Email
- fortunato.lombardo@unime.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UO Medicina Generale a indirizzo Diabetologico e Endocrino-Metabolico
- Principal Investigator Name
- Emanuele Bosi
- Principal Investigator Email
- bosi.emanuele@hsr.it
- Contact Person Name
- Emanuele Bosi
- Contact Person Email
- bosi.emanuele@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU Pediatria
- Principal Investigator Name
- Ivana Rabbone
- Principal Investigator Email
- ivana.rabbone@uniupo.it
- Contact Person Name
- Ivana Rabbone
- Contact Person Email
- ivana.rabbone@uniupo.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOSD Diabetologia Pediatrica e Malattie Metaboliche dell'Età Evolutiva
- Principal Investigator Name
- Carlo Moretti
- Principal Investigator Email
- carlo.moretti@aopd.veneto.it
- Contact Person Name
- Carlo Moretti
- Contact Person Email
- carlo.moretti@aopd.veneto.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 26-01-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Diabeter Nederland B.V.
- Department Name
- Pediatrician-Diabetologist
- Principal Investigator Name
- Hendrik-Jan Aanstoot
- Principal Investigator Email
- h.j.aanstoot@diabeter.nl
- Contact Person Name
- Hendrik-Jan Aanstoot
- Contact Person Email
- h.j.aanstoot@diabeter.nl
Finland
- Earliest CTIS Part Ii Submission Date
- 19-12-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 45
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Oulu University Hospital
- Department Name
- Department of Pediatrics
- Principal Investigator Name
- Riitta Veijola
- Principal Investigator Email
- riitta.veijola@oulu.fi
- Contact Person Name
- Riitta Veijola
- Contact Person Email
- riitta.veijola@oulu.fi
- Site Name
- Tampere University Hospital
- Department Name
- PeeTu
- Principal Investigator Name
- Sauli Palmu
- Principal Investigator Email
- sauli.palmu@tuni.fi
- Contact Person Name
- Sauli Palmu
- Contact Person Email
- sauli.palmu@tuni.fi
- Site Name
- HUS-yhtymae
- Department Name
- New Children's Hospital
- Principal Investigator Name
- Tero Varimo
- Principal Investigator Email
- tero.varimo@hus.fi
- Contact Person Name
- Tero Varimo
- Contact Person Email
- tero.varimo@hus.fi
- Site Name
- Varsinais-Suomen hyvinvointialue
- Department Name
- Pediatric Department
- Principal Investigator Name
- Jorma Toppari
- Principal Investigator Email
- jortop@utu.fi
- Contact Person Name
- Jorma Toppari
- Contact Person Email
- jortop@utu.fi
Poland
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 117
- Number Of Sites
- 4
- Number Of Participants
- 27
Sites
- Site Name
- Umed Clinical Trials Sp. z o.o.
- Principal Investigator Name
- Agnieszka Szadkowska
- Principal Investigator Email
- agnieszka.szadkowska@umed.lodz.pl
- Contact Person Name
- Agnieszka Szadkowska
- Contact Person Email
- agnieszka.szadkowska@umed.lodz.pl
- Site Name
- Mtz Clinical Research Powered By Pratia
- Principal Investigator Name
- Agnieszka Szypowska
- Principal Investigator Email
- agnieszka.szypowska@gmail.com
- Contact Person Name
- Agnieszka Szypowska
- Contact Person Email
- agnieszka.szypowska@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Principal Investigator Name
- Agnieszka Zubkiewicz Kucharska
- Principal Investigator Email
- agnieszka.zubkiewicz@gmail.com
- Contact Person Name
- Agnieszka Zubkiewicz Kucharska
- Contact Person Email
- agnieszka.zubkiewicz@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Principal Investigator Name
- Anna Natalia Woloszyn Durkiewicz
- Principal Investigator Email
- annanataliawoloszyn@gmail.com
- Contact Person Name
- Anna Natalia Woloszyn Durkiewicz
- Contact Person Email
- annanataliawoloszyn@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 07-01-2026
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 106
- Number Of Sites
- 9
- Number Of Participants
- 29
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- Ana Lucía Gómez Gila
- Principal Investigator Email
- alggila@hotmail.com
- Contact Person Name
- Ana Lucía Gómez Gila
- Contact Person Email
- alggila@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Endocrinology & Nutrition
- Principal Investigator Name
- Virginia Bellido
- Principal Investigator Email
- virginiabellido@gmail.com
- Contact Person Name
- Virginia Bellido
- Contact Person Email
- virginiabellido@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Endocrinology & Nutrition
- Principal Investigator Name
- Didac Mauricio
- Principal Investigator Email
- dmauricio@santpau.cat
- Contact Person Name
- Didac Mauricio
- Contact Person Email
- dmauricio@santpau.cat
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- Nancy Elizabeth Portillo Najera
- Principal Investigator Email
- nancyelizabeth.portillonajera@osakidetza.eus
- Contact Person Name
- Nancy Elizabeth Portillo Najera
- Contact Person Email
- nancyelizabeth.portillonajera@osakidetza.eus
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- Roque Cardona Hernandez
- Principal Investigator Email
- roque.cardona@sjd.es
- Contact Person Name
- Roque Cardona Hernandez
- Contact Person Email
- roque.cardona@sjd.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Digestive and Metabolic Diseases
- Principal Investigator Name
- Antonio Jesus Blanco Carrasco
- Principal Investigator Email
- ablanco@clinic.cat
- Contact Person Name
- Antonio Jesus Blanco Carrasco
- Contact Person Email
- ablanco@clinic.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Endocrinology & Nutrition
- Principal Investigator Name
- Lía Nattero Chávez
- Principal Investigator Email
- marialia.nattero@salud.madrid.org
- Contact Person Name
- Lía Nattero Chávez
- Contact Person Email
- marialia.nattero@salud.madrid.org
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Endocrinology, Diabetes & Nutrition
- Principal Investigator Name
- Luis Alberto Vazquez Salvi
- Principal Investigator Email
- luisvazquezsalvi@gmail.com
- Contact Person Name
- Luis Alberto Vazquez Salvi
- Contact Person Email
- luisvazquezsalvi@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- María Francisca Moreno Macián
- Principal Investigator Email
- morenoframac@gmail.com
- Contact Person Name
- María Francisca Moreno Macián
- Contact Person Email
- morenoframac@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 113
- Number Of Sites
- 8
- Number Of Participants
- 28
Sites
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universitaet München
- Principal Investigator Name
- Anette Gabriele Ziegler
- Principal Investigator Email
- anettegabriele.ziegler@helmholtz-munich.de
- Contact Person Name
- Anette Gabriele Ziegler
- Contact Person Email
- anettegabriele.ziegler@helmholtz-munich.de
- Site Name
- Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
- Principal Investigator Name
- Mesut Durmaz
- Principal Investigator Email
- mesut@durmaz-hof.de
- Contact Person Name
- Mesut Durmaz
- Contact Person Email
- mesut@durmaz-hof.de
- Site Name
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
- Principal Investigator Name
- Thomas Schaum
- Principal Investigator Email
- schaum@red-institut.de
- Contact Person Name
- Thomas Scha um
- Contact Person Email
- schaum@red-institut.de
- Site Name
- Asklepios Klinik Sankt Augustin GmbH
- Department Name
- Zentrum fuer Allgemeine Paediatrie und Neonatologie
- Principal Investigator Name
- Gerd Horneff
- Principal Investigator Email
- g.horneff@asklepios.com
- Contact Person Name
- Gerd Horneff
- Contact Person Email
- g.horneff@asklepios.com
- Site Name
- Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
- Principal Investigator Name
- Hans-Peter Kempe
- Principal Investigator Email
- kempe@kempe-stemler.de
- Contact Person Name
- Hans-Peter Kempe
- Contact Person Email
- kempe@kempe-stemler.de
- Site Name
- Klinikum Karlsburg
- Department Name
- Klinik für Diabetes und Stoffwechselerkrankungen
- Principal Investigator Name
- Petra Augstein
- Principal Investigator Email
- augsteinp@drguth.de
- Contact Person Name
- Petra Augstein
- Contact Person Email
- augsteinp@drguth.de
- Site Name
- Hannoversche Kinderheilanstalt
- Department Name
- Kinder- und Jugendkrankenhaus AUF DER BULT, Diabetes- und Endokrinologiezentrum
- Principal Investigator Name
- Felix Reschke
- Principal Investigator Email
- felix.reschke@hka.de
- Contact Person Name
- Felix Reschke
- Contact Person Email
- felix.reschke@hka.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Kinder- und Jugendmedizin
- Principal Investigator Name
- Christian Denzer
- Principal Investigator Email
- christian.denzer@uniklinik-ulm.de
- Contact Person Name
- Christian Denzer
- Contact Person Email
- christian.denzer@uniklinik-ulm.de
Norway
- Earliest CTIS Part Ii Submission Date
- 26-01-2026
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 85
- Number Of Sites
- 6
- Number Of Participants
- 3
Sites
- Site Name
- St. Olavs Hospital HF
- Department Name
- Department of Pediatrics
- Principal Investigator Name
- Torstein Baade Rø
- Principal Investigator Email
- torstein.ro@ntnu.no
- Contact Person Name
- Torstein Baade Rø
- Contact Person Email
- torstein.ro@ntnu.no
- Site Name
- Helse Fonna HF
- Department Name
- Pediatric department
- Principal Investigator Name
- Heiko Bratke
- Principal Investigator Email
- heiko.holger.karl-ernst.bratke@helse-fonna.no
- Contact Person Name
- Heiko Bratke
- Contact Person Email
- heiko.holger.karl-ernst.bratke@helse-fonna.no
- Site Name
- Akershus University Hospital
- Department Name
- Dept. Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Christopher Inchley
- Principal Investigator Email
- inchley@ahus.no
- Contact Person Name
- Christopher Inchley
- Contact Person Email
- inchley@ahus.no
- Site Name
- Oslo Universitetssykehus HF
- Department Name
- Dept. Endocrinology, Morbid obesity and Preventive Medicine
- Principal Investigator Name
- Kari Anne Sveen
- Principal Investigator Email
- kasvee@ous-hf.no
- Contact Person Name
- Kari Anne Sveen
- Contact Person Email
- kasvee@ous-hf.no
- Site Name
- Helse Stavanger HF
- Department Name
- Medical and Endocrinological department
- Principal Investigator Name
- Sondre Meling
- Principal Investigator Email
- sondre.vatne.meling@sus.no
- Contact Person Name
- Sondre Meling
- Contact Person Email
- sondre.vatne.meling@sus.no
- Site Name
- Oslo Universitetssykehus HF
- Department Name
- Unit for Endocrinology and Diabetes, Divison for pediatric and Adolescent Medicine
- Principal Investigator Name
- Lars Krogvold
- Principal Investigator Email
- uxlaog@ous-hf.no
- Contact Person Name
- Lars Krogvold
- Contact Person Email
- uxlaog@ous-hf.no
Sweden
- Earliest CTIS Part Ii Submission Date
- 27-11-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 151
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Region Oerebro Laen
- Department Name
- Department of Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Frida Sundberg
- Principal Investigator Email
- frida.sundberg@oru.se
- Contact Person Name
- Frida Sundberg
- Contact Person Email
- frida.sundberg@oru.se
- Site Name
- ProbarE i Lund AB
- Department Name
- ProbarE i Lund
- Principal Investigator Name
- Anders Luts
- Principal Investigator Email
- anders.luts@probare.se
- Contact Person Name
- Anders Luts
- Contact Person Email
- anders.luts@probare.se
- Site Name
- Region Jaemtland Haerjedalen
- Department Name
- Medicin
- Principal Investigator Name
- David Nöjdh
- Principal Investigator Email
- david.engstrom@regionjh.se
- Contact Person Name
- David Nöjdh
- Contact Person Email
- david.engstrom@regionjh.se
- Site Name
- ProbarE i Stockholm AB
- Department Name
- ProbarE i Stockholm
- Principal Investigator Name
- Peter Bosson
- Principal Investigator Email
- peter.bosson@probare.se
- Contact Person Name
- Peter Bosson
- Contact Person Email
- peter.bosson@probare.se
- Site Name
- NU Hospital Group-Vaestra Goetalandsregionen
- Department Name
- Specialistmedicin
- Principal Investigator Name
- Marcus Lind
- Principal Investigator Email
- marcus.lind@gu.se
- Contact Person Name
- Marcus Lind
- Contact Person Email
- marcus.lind@gu.se
Portugal
- Earliest CTIS Part Ii Submission Date
- 21-11-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 151
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Unidade Local De Saude Do Alto Minho E.P.E.
- Department Name
- Endocrinology
- Principal Investigator Name
- Maria Cristina Roque
- Principal Investigator Email
- helena.pires@blueclinical.pt
- Contact Person Name
- Maria Cristina Roque
- Contact Person Email
- helena.pires@blueclinical.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Pediatric
- Principal Investigator Name
- Teresa Borges
- Principal Investigator Email
- emaildateresa@gmail.com
- Contact Person Name
- Teresa Borges
- Contact Person Email
- emaildateresa@gmail.com
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Endocrinology
- Principal Investigator Name
- Marta Ferreira
- Principal Investigator Email
- marta.ferreira@chvng.min-saude.pt
- Contact Person Name
- Marta Ferreira
- Contact Person Email
- marta.ferreira@chvng.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Pediatric endocrinology and diabetology
- Principal Investigator Name
- Ana Sofia Martins
- Principal Investigator Email
- sofiacgam@gmail.com
- Contact Person Name
- Ana Sofia Martins
- Contact Person Email
- sofiacgam@gmail.com
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA (Iqvia Biotech Limited / IQVIA Connected Devices)
- Responsibilities
- Clinical operations and device services; sponsorDuties codes include 1,2,4 in entries; contact emails: zoran.cemalovic@iqvia.com, sarah.okonkwo2@iqvia.com, els.vannylen@iqvia.com
- Name
- Labcorp (Labcorp Central Laboratory Services LP / Labcorp Central Laboratory Services SARL)
- Responsibilities
- Central laboratory services; sponsorDuties code: 4; contact email: rhonda.orem@labcorp.com
- Name
- Altasciences Compagnie Inc.
- Responsibilities
- Vendor/CRO responsibilities (sponsorDuties code: 4); contact email: spedicelli@altasciences.com
- Name
- Bioclinica Inc.
- Responsibilities
- Data/clinical vendor responsibilities (sponsorDuties code: 4); contact email: robert.murray@clario.com
- Name
- RWS Life Sciences Inc.
- Responsibilities
- Data management / copyright/licensing roles (sponsorDuties code: 15 and 6); contact email: rachel.tuniewicz@rws.com
- Name
- Medidata Solutions Inc.
- Responsibilities
- Electronic data capture/study systems (sponsorDuties code: 7); contact email: Ari.FELDMAN@3ds.com
- Name
- Greenphire LLC
- Responsibilities
- Study development/conduct - patient screening, recruitment, retention (sponsorDuties code: 15); contact email: jes.turner@greenhire.com
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]; contact email: rhonda.orem@labcorp.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"sponsorDuties codes: [2]; contact email: zoran.cemalovic@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"IQVIA Connected Devices","duties_or_roles":"sponsorDuties codes: [4]; contact email: els.vannylen@iqvia.com","organisation_type":"Health care"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Copyright/Licensing:Data Management; contact email: rachel.tuniewicz@rws.com","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: spedicelli@altasciences.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: [15]; value: Study Development/Conduct - Patient Screening, Recruitment, and/or Retention; contact email: jes.turner@greenhire.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc. (second entry)","duties_or_roles":"sponsorDuties codes: [6]; contact email: rachel.tuniewicz@rws.com","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]; contact email: rhonda.orem@labcorp.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Biotech Limited (second entry)","duties_or_roles":"sponsorDuties codes: [1]; contact email: sarah.okonkwo2@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email: robert.murray@clario.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact email: Ari.FELDMAN@3ds.com","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BARICITINIB (film-coated tablet)
- Active Substance
- BARICITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 4 mg per day (maxDailyDoseAmount 4 mg as listed)
- Investigational Product Name
- Baricitinib (oral suspension, sponsor product code LY3009104)
- Active Substance
- BARICITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 2 ml per day (maxDailyDoseAmount 2 ml as listed)
- Investigational Product Name
- Placebo to match LY
- Modality
- Other
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