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Phase 3RecruitingNCT07222332

BARICADE-PRESERVE: Baricitinib in newly diagnosed T1D

What this study tests

Phase-3 trial testing baricitinib in children and adults newly diagnosed with stage-3 T1D, following the positive BANDIT phase-2 result.

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

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Ages 1 to under 36, T1D diagnosed within 100 days before treatment, at least one islet autoantibody, stimulated C-peptide at least 0.2 nmol/L 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=300; estimated primary completion July 2028.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
  • Centre for Children's Health Research, Brisbane — Not yet recruiting
  • Austin Health - Repatriation Hospital, Heidelberg West — Recruiting
  • Ipswich Hospital, Ipswich — Recruiting
  • Royal Children's Hospital, Melbourne — Not yet recruiting
  • Southern Adelaide Diabetes & Endocrine Services, Oaklands Park — 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

  • Change in C-peptide AUC at 52 weeks

The full picture

BARICADE-PRESERVE is a randomized, double-blind, placebo-controlled phase-3 study of oral baricitinib after recent stage-3 T1D diagnosis. The primary endpoint is change from baseline in C-peptide area under the curve at week 52, a measure of remaining insulin secretion. It is a confirmatory study following BANDIT's preservation signal, not a completed efficacy result.12

The registry lists ages 1–35, diagnosis within 100 days before treatment, at least one diabetes-related autoantibody, stimulated C-peptide at least 0.2 nmol/L and weight at least 8 kg. Cardiovascular, thromboembolic, malignancy and infection exclusions also apply. Research eligibility in young children does not establish safety or benefit in those ages.1

No results were posted in the registry checked on 17 September 2026. The estimated 300-person enrolment and July 2028 primary completion date are plans, not outcome denominators or promised readout dates.1

Sources

  1. [1]
    Baricitinib to Preserve Beta Cell Function in Newly Diagnosed Type 1 Diabetes · Trial registry · 2026-09-04 — Registry checked 17 September 2026: RECRUITING; estimated n=300; estimated primary completion July 2028; last update 4 September 2026; no results posted.

    BARICADE-PRESERVE, NCT07222332. ClinicalTrials.gov; update posted 4 September 2026, checked 17 September 2026.

  2. [2]
    Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes · Peer-reviewed study · 2023-12-06 — Historical BANDIT phase-2 evidence; not a result from BARICADE-PRESERVE.

    Waibel M, et al. Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes. NEJM (2023).