BARICADE-DELAY: Baricitinib to delay stage-3 T1D
What this study tests
Phase-3 trial testing whether oral baricitinib can delay progression to clinical stage-3 T1D in at-risk stage-1b/2 children and adults.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-09-04.
Most recent recorded citation date: 2026-09-04. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Ages 1 to under 36 with stage 1b or stage 2 T1D, repeated confirmation of multiple islet autoantibodies and weight at least 8 kg; other safety criteria apply. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. Registry checked 17 September 2026 (ClinicalTrials.gov last update 4 September 2026): still recruiting; estimated n=150; estimated primary completion July 2031.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States, United Kingdom, European Union, Canada, Australia, Japan, Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Australian sites in the registry
- Women's and Children's Hospital, Adelaide — Recruiting
- Box Hill Hospital, Box Hill — Recruiting
- Royal Brisbane and Women's Hospital, Brisbane — Recruiting
- Centre for Children's Health Research, Brisbane — Recruiting
- Royal Children's Hospital, Melbourne — Not yet recruiting
- The Royal Melbourne Hospital, Parkville — Recruiting
- Perth Children's Hospital, Perth — Recruiting
- Sydney Children's Hospital, Randwick — Recruiting
- The Children's Hospital at Westmead, Westmead — Recruiting
Overall recruitment does not imply availability at every site. Confirm eligibility and local recruitment with the study team.
Primary endpoints
- Time to stage-3 type 1 diabetes diagnosis
The full picture
BARICADE-DELAY is a randomized, double-blind, placebo-controlled phase-3 study of oral baricitinib in stage 1b/2 T1D. Its primary endpoint is time from baseline to stage-3 diagnosis over approximately five years. That tests delay of clinical progression; it does not assume permanent prevention.1
The registry lists ages 1–35, weight at least 8 kg, and repeated confirmation of at least two diabetes-related autoantibodies. It excludes specified cardiovascular and thromboembolic risks, malignancy risks and serious infection. The full protocol determines eligibility; a recruiting status does not guarantee a place at a particular site.1
No results were posted in the registry checked on 17 September 2026. The estimated 150-person enrolment and July 2031 primary completion date are plans, not outcome denominators or promised readout dates.1
Sources
- [1]Baricitinib for the Delay of Stage 3 Type 1 Diabetes · Trial registry · 2026-09-04 — Registry checked 17 September 2026: RECRUITING; estimated n=150; estimated primary completion July 2031; last update 4 September 2026; no results posted.
BARICADE-DELAY, NCT07222137. ClinicalTrials.gov; update posted 4 September 2026, checked 17 September 2026.