I4V-MC-JAJJ
Research type
Research Study
Full title
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. (BARICADE-DELAY)
IRAS ID
1012740
Contact name
Maryna Kvochka
Contact email
Sponsor organisation
Eli Lilly
Research summary
Study JAJJ is a Phase 3, event-driven, global, multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial to investigate whether baricitinib delays the onset of Stage 3 T1 diabetes in participants with Stage 1b or Stage 2 T1 diabetes.
Type 1 diabetes is defined by the autoimmune destruction of insulin-producing pancreatic β cells. Early intervention in the disease course by means of disease-modifying therapies is necessary to enhance the preservation of β-cell mass and function. The principal goal of these interventions is to address autoimmune mechanisms to prevent further β-cell loss. Administering such treatments during the initial phases of type 1 diabetes—specifically at Stage 1, Stage 2, or at the transition to Stage 3, when residual β-cell function remains—may contribute to preventing, reversing, or decelerating disease progression. Baricitinib, a Janus kinase (JAK) inhibitor, may alter immune response and decrease inflammation. This study (JAJJ) aims to determine if baricitinib can delay Stage 3 T1 diabetes in people with Stage 1b or Stage 2 T1 diabetes. Approximately 150 children and young adults with Stage 1b or Stage 2 T1 diabetes will be randomly assigned in a 2:1 ratio to receive either baricitinib or placebo. The Treatment period duration for a participant depends on whether they are diagnosed with Stage 3 T1 diabetes (endpoint) and the study will end when the specified number of endpoint events (those who get T1D) occurs in the overall study population.REC name
Wales REC 5
REC reference
25/WA/0267
Date of REC Opinion
16 Oct 2025
REC opinion
Further Information Favourable Opinion