A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years
Status: Recruiting
Location: See all (128) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 35
Healthy Volunteers: f
View:
• Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
• Have at least one diabetes-related autoantibody found at screening
• Show signs of remaining beta-cell function
⁃ stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening
• Weigh at least 8 kilograms (kg) (18 pounds) at screening
Locations
United States
Colorado
Barbara Davis Center for Childhood Diabetes
NOT_YET_RECRUITING
Aurora
Florida
Tallahassee Memorial HealthCare
NOT_YET_RECRUITING
Tallahassee
Pennsylvania
Children's Hospital of Philadelphia (CHOP)
NOT_YET_RECRUITING
Philadelphia
Texas
Driscoll Children's Hospital
NOT_YET_RECRUITING
Corpus Christi
Virginia
University of Virginia
NOT_YET_RECRUITING
Charlottesville
Other Locations
Australia
Women's and Children's Hospital
NOT_YET_RECRUITING
Adelaide
Centre for Children's Health Research
NOT_YET_RECRUITING
Brisbane
Austin Health - Repatriation Hospital
NOT_YET_RECRUITING
Heidelberg West
Ipswich Hospital
NOT_YET_RECRUITING
Ipswich
Royal Children's Hospital
NOT_YET_RECRUITING
Melbourne
Southern Adelaide Diabetes & Endocrine Services
RECRUITING
Oaklands Park
The Royal Melbourne Hospital
RECRUITING
Parkville
Perth Children's Hospital
NOT_YET_RECRUITING
Perth
Sydney Children's Hospital
NOT_YET_RECRUITING
Randwick
The Children's Hospital at Westmead
NOT_YET_RECRUITING
Westmead
Belgium
Cliniques universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
Université Libre de Bruxelles - Hôpital Erasme
NOT_YET_RECRUITING
Brussels
UZ Brussel
NOT_YET_RECRUITING
Brussels
Antwerp University Hospital
NOT_YET_RECRUITING
Edegem
UZ Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
NOT_YET_RECRUITING
Liège
CHU UCL Namur/Site Sainte Elisabeth
NOT_YET_RECRUITING
Namur
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
NOT_YET_RECRUITING
Yvoir
Brazil
Hospital Universitário Maria Aparecida Pedrossian
NOT_YET_RECRUITING
Campo Grande
Centro de Diabetes Curitiba
NOT_YET_RECRUITING
Curitiba
Quanta Diagnóstico e Terapia
NOT_YET_RECRUITING
Curitiba
Centro De Diabetes Metabolismo E Endocrinologia
NOT_YET_RECRUITING
Fortaleza
Cendi - Endocrinologia e Diabetes
NOT_YET_RECRUITING
Goiânia
Centro de Pesquisa Clínica de Marília - CPCLIM
NOT_YET_RECRUITING
Marília
Instituto da Crianca com Diabetes
NOT_YET_RECRUITING
Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T
NOT_YET_RECRUITING
Ribeirão Preto
Universidade Federal do Rio de Janeiro
NOT_YET_RECRUITING
Rio De Janeiro
Clínica Hepatogastro JK
NOT_YET_RECRUITING
São Paulo
CPCLIN
NOT_YET_RECRUITING
São Paulo
Hospital das Clinicas FMUSP
NOT_YET_RECRUITING
São Paulo
IBTED - Tecnologia e Educação em Diabetes
NOT_YET_RECRUITING
São Paulo
Instituto de Pesquisa Clinica
NOT_YET_RECRUITING
São Paulo
CEDOES
NOT_YET_RECRUITING
Vitória
Canada
Alberta Children's Hospital
NOT_YET_RECRUITING
Calgary
CIUSSS- saguenay-Lac-Saint-Jean
NOT_YET_RECRUITING
Chicoutimi
Alberta Diabetes Institute
NOT_YET_RECRUITING
Edmonton
St. Joseph's Health Care
NOT_YET_RECRUITING
London
Centricity Research Ottawa LMC Endocrinology
NOT_YET_RECRUITING
Ottawa
CHUL et Centre mère-enfant Soleil
NOT_YET_RECRUITING
Québec
BC Diabetes Office
NOT_YET_RECRUITING
Vancouver
Finland
New Children's Hospital
NOT_YET_RECRUITING
Helsinki
Oulun yliopistollinen sairaala
NOT_YET_RECRUITING
Oulu
Tampereen yliopistollinen sairaala
NOT_YET_RECRUITING
Tampere
Turku University Hospital
NOT_YET_RECRUITING
Turku
France
Hospices Civils de Lyon - Hopital Louis Pradel
NOT_YET_RECRUITING
Bron
Centre Hospitalier Sud Francilien
NOT_YET_RECRUITING
Corbeil-essonnes
Centre Hospitalier Universitaire de Grenoble
NOT_YET_RECRUITING
Grenoble
Hopital Claude Huriez - CHU de Lille
NOT_YET_RECRUITING
Lille
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
NOT_YET_RECRUITING
Marseille
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
NOT_YET_RECRUITING
Paris
Hôpital Universitaire Necker Enfants Malades
NOT_YET_RECRUITING
Paris
Pitie Salpetriere University Hospital
NOT_YET_RECRUITING
Paris
CHU Rangueil
NOT_YET_RECRUITING
Toulouse
Germany
Hannoversche Kinderheilanstalt
NOT_YET_RECRUITING
Hanover
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
RECRUITING
Hof
Klinikum Karlsburg
NOT_YET_RECRUITING
Karlsburg
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
RECRUITING
Ludwigshafen Am Rhein
TUM Klinikum
NOT_YET_RECRUITING
München
RED-Institut GmbH
RECRUITING
Oldenburg
Asklepios Klinik Sankt Augustin
NOT_YET_RECRUITING
Sankt Augustin
Universitaetsklinikum Ulm
RECRUITING
Ulm
Israel
Yitzhak Shamir Medical Center
RECRUITING
Beer Yaacov
Soroka Medical Center
NOT_YET_RECRUITING
Beersheba
Linn Medical Center
NOT_YET_RECRUITING
Haifa
Rambam Health Care Campus
NOT_YET_RECRUITING
Haifa
Institute of Diabetes, Technology and Research - Clalit Health
NOT_YET_RECRUITING
Herzliya
Hadassah Medical Center
RECRUITING
Jerusalem
Meir Medical Center
NOT_YET_RECRUITING
Kfar Saba
Rabin Medical Center
NOT_YET_RECRUITING
Petah Tikva
Schneider Children's Medical Center
NOT_YET_RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliera Universitaria Careggi
NOT_YET_RECRUITING
Florence
Azienda Ospedaliera Universitaria Meyer IRCCS
NOT_YET_RECRUITING
Florence
Azienda Ospedaliera Universitaria Di Messina G. Martino
RECRUITING
Messina
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
University of Naples Federico II
RECRUITING
Naples
Azienda Ospedaliero Universitaria Maggiore della Carità
RECRUITING
Novara
Azienda Ospedale - Università Padova
NOT_YET_RECRUITING
Padova
Azienda Ospedale - Università Padova
NOT_YET_RECRUITING
Padova
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
NOT_YET_RECRUITING
Verona
Netherlands
Diabeter - Rotterdam
NOT_YET_RECRUITING
Rotterdam
Norway
Helse Fonna - Haugesund Sjukehus
NOT_YET_RECRUITING
Haugesund
Akershus Universitetssykehus
NOT_YET_RECRUITING
Lørenskog
Oslo Universitetssykehus Aker
NOT_YET_RECRUITING
Oslo
Oslo Universitetssykehus Ullevål
NOT_YET_RECRUITING
Oslo
Stavanger Universitetssykehus
NOT_YET_RECRUITING
Stavanger
St. Olavs Hospital
NOT_YET_RECRUITING
Trondheim
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
UMED Clinical Trials
NOT_YET_RECRUITING
Lodz
MTZ Clinical Research Powered by Pratia
RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
NOT_YET_RECRUITING
Wroclaw
Portugal
2Ca Braga
NOT_YET_RECRUITING
Braga
Centro Materno Infantil do Norte
NOT_YET_RECRUITING
Porto
ULSAM - Hospital de Santa Luzia
NOT_YET_RECRUITING
Viana Do Castelo
Unidade Local De Saude De Gaia/Espinho E.P.E.
NOT_YET_RECRUITING
Vila Nova De Gaia
Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
NOT_YET_RECRUITING
Barakaldo
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen Del Rocio
NOT_YET_RECRUITING
Seville
Hospital Universitario Virgen Del Rocio
NOT_YET_RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
NOT_YET_RECRUITING
Valencia
Sweden
ProbarE i Lund AB
NOT_YET_RECRUITING
Lund
Universitetssjukhuset Örebro
NOT_YET_RECRUITING
Örebro
Östersunds Sjukhus
NOT_YET_RECRUITING
Östersund
ProbarE i Stockholm AB
NOT_YET_RECRUITING
Stockholm
Uddevalla Sjukhus
NOT_YET_RECRUITING
Uddevalla
Ukraine
Institute of Endocrinology and Metabolism named after Komissarenko
RECRUITING
Kiev
Kyiv City Endocrinological Center
RECRUITING
Kyiv
Zakarpattia Endoclinic
RECRUITING
Uzhhorod
Vinnytsia Regional Clinical Endocrinology Dispensary
RECRUITING
Vinnytsia
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Birmingham Children's Hospital
NOT_YET_RECRUITING
Birmingham
Queen Elizabeth Hospital Birmingham
NOT_YET_RECRUITING
Birmingham
Southmead Hospital
NOT_YET_RECRUITING
Bristol
Addenbrooke's Hospital
RECRUITING
Cambridge
University Hospital of Wales
NOT_YET_RECRUITING
Cardiff
Churchill Hospital
NOT_YET_RECRUITING
Oxford
Southampton General Hospital
NOT_YET_RECRUITING
Southampton
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2028-07
Participants
Target number of participants: 300
Treatments
Experimental: Baricitinib
Participants will receive baricitinib orally
Placebo_comparator: Placebo
Participants will receive placebo orally
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company