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NCT03782636: ITAD

Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

Active, enrolled Phase 2 Last updated 29 September 2025
What this trial tests

Phase 2 trial testing Aldesleukin in Type1 Diabetes in 41 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
28 January 2019
Primary endpoint
16 February 2023
1 September 2026

Quick facts

Lead sponsorUniversity of Oxford
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment41
Start date28 January 2019
Primary completion16 February 2023
Estimated completion1 September 2026
Sites5 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Oxford

Who can join

Adults 6 to 18, any sex, with Type1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The main purpose of this study is to see if a drug called aldesleukin, can preserve insulin production in children and young adults recently diagnosed with type 1 diabetes. One group will receive aldesleukin and the other a placebo.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Rebalancing Immune Homeostasis to Treat Autoimmune Diseases.
    Horwitz DA, Fahmy TM, Piccirillo CA, La Cava A. · · 2019 · cited 87× · PMID 31601519 · DOI 10.1016/j.it.2019.08.003
  2. Low-dose IL-2 reduces IL-21<sup>+</sup> T cell frequency and induces anti-inflammatory gene expression in type 1 diabetes.
    Zhang JY, Hamey F, Trzupek D, Mickunas M, et al · · 2022 · cited 23× · PMID 36443294 · DOI 10.1038/s41467-022-34162-3
  3. Strategies to Use Nanoparticles to Generate CD4 and CD8 Regulatory T Cells for the Treatment of SLE and Other Autoimmune Diseases.
    Horwitz DA, Bickerton S, La Cava A. · · 2021 · cited 20× · PMID 34211471 · DOI 10.3389/fimmu.2021.681062
  4. Therapeutic Strategies for Diabetes: Immune Modulation in Pancreatic β Cells.
    Jo S, Fang S. · · 2021 · cited 18× · PMID 34484126 · DOI 10.3389/fendo.2021.716692
  5. Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD): a phase 2, multicentre, double-blind, randomized, placebo-controlled trial.
    Marcovecchio ML, Wicker LS, Dunger DB, Dutton SJ, et al · · 2020 · cited 18× · PMID 32399500 · DOI 10.12688/wellcomeopenres.15697.1

Verify or expand the search:

Other trials of Aldesleukin

Trials testing the same drug.

Other recruiting trials for Type1 Diabetes

Currently open trials in the same condition.

Other University of Oxford trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03782636.

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