Last reviewed · How we verify
NCT03782636: ITAD
Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)
Phase 2 trial testing Aldesleukin in Type1 Diabetes in 41 participants. Participants enrolled and being followed up; not accepting new ones.
16 February 2023
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 28 January 2019 |
| Primary completion | 16 February 2023 |
| Estimated completion | 1 September 2026 |
| Sites | 5 locations across United Kingdom |
Drugs / interventions tested
- Aldesleukin (ALDESLEUKIN) — full drug profile →
- Placebo
Conditions studied
- Type1 Diabetes — all drugs for Type1 Diabetes →
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.
-
Differences in slopes of DBS (Dried Blood Spot) C-peptide over the 6 month-treatment period between the active and placebo groups.
Time frame: Weekly DBS C-peptide collected during the 6-month treatment period, and then monthly during the 6 months of follow-up
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03782636
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aldesleukin
Trials testing the same drug.
- NCT07389239 — A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies. · Phase 1, PHASE2 · not yet recruiting
- NCT06626256 — STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Ca · Phase 1 · withdrawn
- NCT06690281 — A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced · Phase 2 · withdrawn
- NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers · Phase 1, PHASE2 · recruiting
- NCT05989828 — A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple N · Phase 1 · suspended
Other recruiting trials for Type1 Diabetes
Currently open trials in the same condition.
- NCT06408207 — CGM Academy for Youth With Type 1 Diabetes · NA · recruiting
Other University of Oxford trials
Trials by the same sponsor.
- NCT05380388 — A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 ) · Phase 2 · not yet recruiting
- NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults · Phase 1 · not yet recruiting
- NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis · not yet recruiting
- NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE · Phase 3 · not yet recruiting
- NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03782636 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oxford
- Last refreshed: 29 September 2025
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing