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Phase 2Active, not recruitingNCT05153070

Ciclosporin followed by low-dose IL-2 in recent-onset T1D

What this study tests

DF-IL2-REP compares low-dose IL-2 (ILT-101) with placebo after a shared course of ciclosporin in recent-onset T1D. The EU registry records recruitment ending in November 2025, while ClinicalTrials.gov still labels it recruiting.

Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).

Registry checked: 2026-09-17. Registry’s own update: 2026-09-09.

Latest dated source in the citation list: 2026-09-09. This is the source’s date, not a new review of every claim.

Trial status, labels and access can change between reviews. Review coverage and open work · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Protocol version 9 and CTIS specify ages 16–45, completed puberty (Tanner stage 5), stage 3 T1D diagnosed within three months and at least one diabetes autoantibody. Additional residual-function, medical and safety criteria apply. This is not a confirmation of open recruitment. 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 are posted in ClinicalTrials.gov or CTIS as of 17 September 2026. Primary outcome timing and recruitment/completion fields differ; protocol and registry distinctions are described below.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: 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 16 September review-note archive and current review coverage. Later changes and new records may not appear in the earlier notes. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Registry status: Recruiting. The displayed trial status also reflects the cited study evidence.

Primary endpoints

  • Change in regulatory T-cell values from day 63 to day 70 in protocol version 9 and CTIS; ClinicalTrials.gov instead lists day 67 versus day 63.

The full picture

This phase 2 randomized, double-blind trial gives both groups two months of ciclosporin, followed by ILT-101 or placebo with insulin continued. Protocol version 9, dated 1 June 2026, targets 24 evaluable participants who receive IL-2/placebo and permits up to 50 enrolled participants to replace withdrawals before that treatment. ClinicalTrials.gov lists 24 as estimated enrollment; these are not reported analysis denominators.12

The primary endpoint measures regulatory T cells, not insulin independence. CTIS and protocol version 9 specify day 70 compared with day 63; ClinicalTrials.gov lists day 67. Residual insulin secretion, insulin requirements, HbA1c and adverse events are secondary measures. No results are posted in either registry.132

Recruitment and timing differ between registries. CTIS records the end of recruitment on 27 November 2025 and an estimated trial end of 20 April 2028. ClinicalTrials.gov still says recruiting and estimates primary and study completion on 29 November 2027. This page displays active, not recruiting, using the dated CTIS recruitment event; the separate ClinicalTrials.gov status is preserved below.31

The public protocol resolves two other discrepancies: it specifies ages 16–45 rather than the 16–35 in the ClinicalTrials.gov narrative, and a total daily ciclosporin dose divided into two administrations. ClinicalTrials.gov contains inconsistent dose wording, so this page does not provide a treatment dose. Protocol version 9 identifies kidney toxicity and hypertension among ciclosporin risks; trial registration is not evidence of a safe routine T1D treatment.21

ClinicalTrials.gov records the study start as 21 September 2022 (actual), also matching the CTIS start-of-trial event. The lead sponsor is Assistance Publique – Hôpitaux de Paris, with ILTOO Pharma listed as collaborator.13

References

  1. ClinicalTrials.gov. NCT05153070. Last update posted 2026-09-09; checked 17 September 2026. https://clinicaltrials.gov/study/NCT05153070 ↩ ↩2 ↩3 ↩4 ↩5

  2. Assistance Publique – Hôpitaux de Paris. DF-IL2-REP protocol version 9.0, 1 June 2026, pages 9–13 and 17–18. Official CTIS document endpoint: https://euclinicaltrials.eu/ctis-public-api/documents/2024-514043-29-00/95b3b6c4-bbb2-4d37-8d99-4794475007ca/download ↩ ↩2 ↩3

  3. CTIS. 2024-514043-29-00. Official public record checked 17 September 2026. https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-514043-29-00 ↩ ↩2 ↩3

Sources

  1. [1]Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes (NCT05153070) · Trial registry · 2026-09-09 — Current registered protocol, eligibility, endpoints and status checked 17 September 2026; the citation date records the registry update, not a results publication.
  2. [2]DF-IL2-REP: CTIS 2024-514043-29-00 public record · Trial registry — Official CTIS data checked 17 September 2026; includes the dated end-of-recruitment event and current trial information.
  3. [3]DF-IL2-REP protocol version 9.0, 1 June 2026 · Trial registry · 2026-06-01 — Official CTIS protocol download endpoint; returns a temporary download link. Pages 9–13 and 17–18 were checked for design, eligibility, endpoints, dose wording and risks.