A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years
Status: Recruiting
Location: See all (107) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 35
Healthy Volunteers: f
View:
• Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening
• Have Stage 1b or Stage 2 type 1 diabetes
• Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening
Locations
United States
Florida
Tallahassee Memorial HealthCare
NOT_YET_RECRUITING
Tallahassee
University of South Florida
SUSPENDED
Tampa
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Iowa Diabetes and Endocrinology Research Center
RECRUITING
West Des Moines
Kentucky
Novak Center for Children's Health
NOT_YET_RECRUITING
Louisville
Pennsylvania
Children's Hospital of Philadelphia (CHOP)
NOT_YET_RECRUITING
Philadelphia
Virginia
University of Virginia
NOT_YET_RECRUITING
Charlottesville
Other Locations
Australia
Women's and Children's Hospital
RECRUITING
Adelaide
Box Hill Hospital
RECRUITING
Box Hill
Centre for Children's Health Research
NOT_YET_RECRUITING
Brisbane
Royal Brisbane and Women's Hospital
NOT_YET_RECRUITING
Brisbane
Royal Children's Hospital
NOT_YET_RECRUITING
Melbourne
The Royal Melbourne Hospital
RECRUITING
Parkville
Perth Children's Hospital
RECRUITING
Perth
Sydney Children's Hospital
RECRUITING
Randwick
The Children's Hospital at Westmead
RECRUITING
Westmead
Belgium
Cliniques universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
UZ Brussel
NOT_YET_RECRUITING
Brussels
Antwerp University Hospital
NOT_YET_RECRUITING
Edegem
UZ Leuven
RECRUITING
Leuven
CHU UCL Namur/Site Sainte Elisabeth
NOT_YET_RECRUITING
Namur
Brazil
Freire Pesquisa Clínica
RECRUITING
Belo Horizonte
Centro de Diabetes Curitiba
RECRUITING
Curitiba
Hospital Universitario Walter Cantidio
RECRUITING
Fortaleza
Cendi - Endocrinologia e Diabetes
RECRUITING
Goiânia
Centro de Pesquisa Clínica de Marília - CPCLIM
RECRUITING
Marília
Universidade Federal do Rio de Janeiro
RECRUITING
Rio De Janeiro
CPCLIN
RECRUITING
São Paulo
Hospital das Clinicas FMUSP
RECRUITING
São Paulo
IBTED - Tecnologia e Educação em Diabetes
RECRUITING
São Paulo
Instituto de Pesquisa Clinica
RECRUITING
São Paulo
Canada
Alberta Diabetes Institute
NOT_YET_RECRUITING
Edmonton
BC Diabetes Office
RECRUITING
Vancouver
Finland
Oulun yliopistollinen sairaala
NOT_YET_RECRUITING
Oulu
Tampereen yliopistollinen sairaala
NOT_YET_RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
France
Hospices Civils de Lyon - Hopital Louis Pradel
NOT_YET_RECRUITING
Bron
Centre Hospitalier Sud Francilien
NOT_YET_RECRUITING
Corbeil-essonnes
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
Hopitaux Universitaires Paris Centre-Hopital Cochin
NOT_YET_RECRUITING
Paris
Pitie Salpetriere University Hospital
NOT_YET_RECRUITING
Paris
CHU Rangueil
NOT_YET_RECRUITING
Toulouse
Germany
Universitaetsklinikum Augsburg
RECRUITING
Augsburg
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
NOT_YET_RECRUITING
Dresden
Hannoversche Kinderheilanstalt
RECRUITING
Hanover
TUM Klinikum
RECRUITING
München
Israel
Yitzhak Shamir Medical Center
RECRUITING
Beer Yaacov
Soroka Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Institute of Diabetes, Technology and Research - Clalit Health
RECRUITING
Herzliya
Hadassah Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Rabin Medical Center
RECRUITING
Petah Tikva
Schneider Children's Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Kaplan Medical Center
RECRUITING
Rehovot
Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Ospedale Pediatrico Salesi
RECRUITING
Ancona
IRCCS - AOU di Bologna
RECRUITING
Bologna
Ospedale Microcitemico
NOT_YET_RECRUITING
Cagliari
Azienda Ospedaliera Universitaria Meyer IRCCS
RECRUITING
Florence
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
University of Naples Federico II
RECRUITING
Naples
University of Naples Federico II
RECRUITING
Naples
Azienda Ospedaliero Universitaria Maggiore della Carità
RECRUITING
Novara
Azienda Ospedale - Università Padova
NOT_YET_RECRUITING
Padova
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
RECRUITING
Verona
Japan
Abeno Medical Clinic
RECRUITING
Abeno
Saitama Medical University Hospital
RECRUITING
Iruma
Nippon Medical School Musashi Kosugi Hospital
RECRUITING
Kawasaki
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
Seino Internal Medicine Clinic
RECRUITING
Kōriyama
Jinnouchi Hospital
RECRUITING
Kumamoto
Nagano Municipal Hospital
RECRUITING
Nagano
Nakakinen clinic
RECRUITING
Naka
Niigata University Medical & Dental Hospital
RECRUITING
Niigata
Netherlands
Diabeter - Rotterdam
NOT_YET_RECRUITING
Rotterdam
Norway
Haukeland Universitetssjukehus
RECRUITING
Bergen
Akershus Universitetssykehus
RECRUITING
Lørenskog
Oslo Universitetssykehus Aker
RECRUITING
Oslo
Oslo Universitetssykehus Ullevål
RECRUITING
Oslo
Stavanger Universitetssykehus
RECRUITING
Stavanger
Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
RECRUITING
Warsaw
MTZ Clinical Research Powered by Pratia
NOT_YET_RECRUITING
Warsaw
Portugal
2Ca Braga
RECRUITING
Braga
Unidade Local de Saude de Matosinhos
NOT_YET_RECRUITING
Matosinhos Municipality
Centro Materno Infantil do Norte
NOT_YET_RECRUITING
Porto
ULSAM - Hospital de Santa Luzia
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
RECRUITING
Barakaldo
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Sweden
Skånes Universitetssjukhus Malmö
RECRUITING
Malmö
Universitetssjukhuset Örebro
NOT_YET_RECRUITING
Örebro
United Kingdom
Birmingham Children's Hospital
NOT_YET_RECRUITING
Birmingham
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
Noah's Ark Children's Hospital for Wales
RECRUITING
Cardiff
University Hospital of Wales
RECRUITING
Cardiff
Queen Elizabeth University Hospital
NOT_YET_RECRUITING
Glasgow
Royal London Hospital
RECRUITING
London
St. George's Hospital
RECRUITING
London
The John Radcliffe Hospital
NOT_YET_RECRUITING
Oxford
Southampton General Hospital
RECRUITING
Southampton
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2031-07
Participants
Target number of participants: 150
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