Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

NCT03782636 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 13341
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• Differences in slopes of DBS (Dried Blood Spot) C-peptide over the 6 month-treatment period between the active and placebo groups.

  Weekly DBS C-peptide collected during the 6-month treatment period, and then monthly during the 6 months of follow-up

Secondary Outcomes (12)

• Change in Treg, Teff and NK56bright cell frequencies and phenotypes from baseline

  At baseline and then1, 2 , 3, 6 and 12 months from the beginning of treatment

• Safety will be assessed at each visit (reported reactions using CTCAE grading v5.0)

  At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment

• Safety will be assessed at each visit (temperature in celsius)

  At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment

• Safety will be assessed at each visit (weight, in kilograms)

  At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment

• Safety will be assessed at each visit (blood pressure: systolic/diastolic)

  At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment

Study Arms (2)

Aldesleukin

EXPERIMENTAL

Ultra-low dose aldesleukin injected subcutaneously, at a dose of 0.2 x 106 IU/m2 twice-weekly , three days apart, for 6 months.

Drug: Aldesleukin

Placebo

PLACEBO COMPARATOR

Placebo sc, at a similar dose (expressed in ml) to the active drug

Other: Placebo

Interventions

Aldesleukin DRUG

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

Aldesleukin

Placebo OTHER

sterile diluent used for the aldesleukin preparation and 5% glucose

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have given written informed consent to participate or assent with parental consent
• Be aged 6-18 years
• Be diagnosed with T1D (Type 1 Diabetes) (at least one autoantibody positive), requiring insulin treatment
• Be within 6 weeks from diagnosis of T1D (at screening)
• Have a random C-peptide \> 200 pmol/l
• Normal full blood count

You may not qualify if:

• Non-type 1 diabetes (type 2 or monogenic diabetes) and secondary diabetes
• Pre-existing autoimmune disease (excluding type 1 diabetes)
• Hypersensitivity to aldesleukin or any of the excipients
• History of severe cardiac disease (NYHA Class III or IV)
• History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
• Clinically significant abnormal laboratory values (out of range and associated with clinical symptoms or signs) in haematology, biochemistry, thyroid, liver and kidney function
• Pre-existing severe major organ dysfunction or seizure disorders
• Participation in another clinical trial (CTIMP) within 4 months prior to screening
• Females who are pregnant, lactating or intend to get pregnant during the study
• Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial
• Sexually active males who are unwilling or unable to comply with contraceptive advice
• Current use of immunosuppressive agents or steroids
• Current treatment with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic products
• Active clinical infections - participants can be recruited after a minimum period of 48 h after last day of feeling unwell or last day of antibiotic/anti-viral treatment
• Children with compliance problems (families where the local investigators consider that problems with compliance may be an issue)

Sponsors & Collaborators

• University of Oxford: lead
• Oxford Clinical Trials Research Unit (OCTRU): collaborator
• Centre for Statistics in Medicine, Oxford: collaborator
• Juvenile Diabetes Research Foundation: collaborator
• Wellcome Trust: collaborator

Study Sites (5)

Oxford Children's Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

The Great North Children's Hospital

Newcastle upon Tyne, United Kingdom

Location

Nottingham Children's Hospital

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

aldesleukin

Study Officials

• Paul Johnson, Professor

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: December 20, 2018
• Study Start: January 28, 2019
• Primary Completion: February 16, 2023
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

GB (5)