I4V-MC-JAJK
Research type
Research Study
Full title
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 (BARICADE-PRESERVE)
IRAS ID
1012673
Contact name
Maryna Kvochka
Contact email
Sponsor organisation
Eli Lilly and Company
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Study I4V-MC-JAJK aims to evaluate the efficacy and safety of baricitinib versus placebo in the preservation of β-cell function in participants, aged ≥1 to <36 years, who have been newly diagnosed with Type 1 Diabetes (T1D).
Type 1 diabetes (T1D) is characterised by the autoimmune destruction of the insulin-producing pancreatic β-cells. To optimise the preservation of β-cell mass and function through disease-modifying therapies, it is essential to intervene early in the course of the disease. The primary objective of these therapies is to target autoimmune mechanisms and prevent further destruction of β-cells. Administering disease-modifying treatments during the early stages of T1D, Stage 1 or Stage 2, or around the time of the transition to Stage 3, when the remaining β cells still have some ability to secrete insulin, may help prevent, reverse, or slow the progression of the disease.
Baricitinib is a type of drug known as a Janus kinase (JAK) inhibitor which can influence the immune system and has anti-inflammatory effects. The Phase 3 Study JAJK is designed to investigate whether baricitinib can preserve β-cell function in participants with newly diagnosed T1D (Stage 3). Approximately 300 participants with Type 1 Diabetes will be randomly assigned in a 2:1 ratio to receive either baricitinib or placebo.
The study duration will be up to 60 weeks, and will consist of 3 periods:
•Screening and lead-in period: up to 4 weeks
•Treatment period: 52 weeks
•Safety follow-up period: 4 weeks
The study intervention must be initiated within 100 days of T1D diagnosis.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0720
Date of REC Opinion
28 Nov 2025
REC opinion
Further Information Favourable Opinion