STRIDE siplizumab in adults with new-onset T1D
What this study tests
Terminated randomized phase-2 study of the anti-CD2 antibody siplizumab in adults with new-onset T1D. The sponsor attributed the early stop to business reasons rather than safety, efficacy, or regulatory concerns; no results are posted.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2025-08-14.
Most recent recorded citation date: 2025-08-14. 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?
- Adults aged 18-45 with T1D; see the registry for full criteria. 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. The trial enrolled nine participants rather than the planned 114 and ended on 24 July 2025. The sponsor says it was terminated for business reasons and that the decision was not related to safety, efficacy, or regulatory concerns. That statement explains this study's stop reason; it is not evidence that siplizumab is safe or effective in T1D.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 Kingdom, European Union. 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.
Primary endpoints
- Change from baseline in beta-cell function versus placebo at week 52
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]NCT06025110: STRIDE siplizumab in new-onset T1D · Trial registry · 2025-08-14 — TERMINATED; actual n=9; study ran January 2023 to July 2025 across the UK and four EU countries. Sponsor-reported reason: business decision not related to safety, efficacy, or regulatory concerns.