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
NOT_YET_RECRUITING
Tampa
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Iowa Diabetes and Endocrinology Research Center
NOT_YET_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
NOT_YET_RECRUITING
Adelaide
Box Hill Hospital
NOT_YET_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
NOT_YET_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
UZ Brussel
NOT_YET_RECRUITING
Brussels
Antwerp University Hospital
NOT_YET_RECRUITING
Edegem
UZ Leuven
NOT_YET_RECRUITING
Leuven
CHU UCL Namur/Site Sainte Elisabeth
NOT_YET_RECRUITING
Namur
Brazil
Freire Pesquisa Clínica
NOT_YET_RECRUITING
Belo Horizonte
Centro de Diabetes Curitiba
NOT_YET_RECRUITING
Curitiba
Hospital Universitario Walter Cantidio
NOT_YET_RECRUITING
Fortaleza
Cendi - Endocrinologia e Diabetes
NOT_YET_RECRUITING
Goiânia
Centro de Pesquisa Clínica de Marília - CPCLIM
NOT_YET_RECRUITING
Marília
Universidade Federal do Rio de Janeiro
NOT_YET_RECRUITING
Rio De Janeiro
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
Canada
Alberta Diabetes Institute
NOT_YET_RECRUITING
Edmonton
BC Diabetes Office
NOT_YET_RECRUITING
Vancouver
Finland
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
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
NOT_YET_RECRUITING
Augsburg
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
NOT_YET_RECRUITING
Dresden
Hannoversche Kinderheilanstalt
NOT_YET_RECRUITING
Hanover
TUM Klinikum
NOT_YET_RECRUITING
München
Israel
Yitzhak Shamir Medical Center
RECRUITING
Beer Yaacov
Soroka Medical Center
NOT_YET_RECRUITING
Beersheba
Rambam Health Care Campus
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
Kaplan Medical Center
NOT_YET_RECRUITING
Rehovot
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Italy
Ospedale Pediatrico Salesi
NOT_YET_RECRUITING
Ancona
IRCCS - AOU di Bologna
NOT_YET_RECRUITING
Bologna
Ospedale Microcitemico
NOT_YET_RECRUITING
Cagliari
Azienda Ospedaliera Universitaria Meyer IRCCS
NOT_YET_RECRUITING
Florence
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
University of Naples Federico II
NOT_YET_RECRUITING
Napoli
University of Naples Federico II
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliero Universitaria Maggiore della Carità
RECRUITING
Novara
Azienda Ospedale - Università Padova
NOT_YET_RECRUITING
Padua
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
NOT_YET_RECRUITING
Verona
Japan
Abeno Medical Clinic
NOT_YET_RECRUITING
Abeno
Saitama Medical University Hospital
NOT_YET_RECRUITING
Iruma
Nippon Medical School Musashi Kosugi Hospital
NOT_YET_RECRUITING
Kawasaki
Yamanashi Prefectural Central Hospital
NOT_YET_RECRUITING
Kofu
Seino Internal Medicine Clinic
NOT_YET_RECRUITING
Kōriyama
Jinnouchi Hospital
NOT_YET_RECRUITING
Kumamoto
Nagano Municipal Hospital
NOT_YET_RECRUITING
Nagano
Soleil Chikusa Clinic
NOT_YET_RECRUITING
Nagoya
Nakakinen clinic
NOT_YET_RECRUITING
Naka
Niigata University Medical & Dental Hospital
NOT_YET_RECRUITING
Niigata
Netherlands
Diabeter - Rotterdam
NOT_YET_RECRUITING
Rotterdam
Norway
Haukeland Universitetssjukehus
NOT_YET_RECRUITING
Bergen
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
Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
NOT_YET_RECRUITING
Warsaw
Portugal
2Ca Braga
NOT_YET_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
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 Sant Joan de Déu
NOT_YET_RECRUITING
Esplugues De Llobregat
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Sweden
Skånes Universitetssjukhus Malmö
NOT_YET_RECRUITING
Malmo
Universitetssjukhuset Örebro
NOT_YET_RECRUITING
Örebro
United Kingdom
Birmingham Children's Hospital
NOT_YET_RECRUITING
Birmingham
Queen Elizabeth Hospital Birmingham
NOT_YET_RECRUITING
Birmingham
Addenbrooke's Hospital
NOT_YET_RECRUITING
Cambridge
Noah's Ark Children's Hospital for Wales
NOT_YET_RECRUITING
Cardiff
University Hospital of Wales
NOT_YET_RECRUITING
Cardiff
Queen Elizabeth University Hospital
NOT_YET_RECRUITING
Glasgow
Royal London Hospital
RECRUITING
London
St. George's Hospital
NOT_YET_RECRUITING
London
The John Radcliffe 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
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