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Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

NCT03782636 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Type1 Diabetes

Interventions

DRUG

Aldesleukin

PROLEUKIN® 18 x 106 IU Powder for solution for injection or infusion

OTHER

Placebo

sterile diluent used for the aldesleukin preparation and 5% glucose

Sponsors & Collaborators

  • Oxford Clinical Trials Research Unit (OCTRU)

    collaborator UNKNOWN

  • Centre for Statistics in Medicine, Oxford

    collaborator UNKNOWN

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Paul Johnson, Professor · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2023-02-16
Completion
2026-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782636 on ClinicalTrials.gov