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Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD) (ITAD)

Primary Purpose

Type1 Diabetes

Status

Unknown status

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Aldesleukin

Placebo

About this trial

This is an interventional treatment trial for Type1 Diabetes

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the participant ineligible for inclusion because of a safety concern
Children with compliance problems (families where the local investigators consider that problems with compliance may be an issue)

Sites / Locations

Oxford Children's Hospital
Bristol Royal Hospital for Children
Addenbrooke's Hospital
The Great North Children's Hospital
Nottingham Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aldesleukin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Assessment of the most commonly reported reactions to low- or high-dose aldesleukin, namely influenza-like syndrome, skin reaction, diarrhoea, nausea using CTCAE grading v5.0

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

Vital signs - temperature in celsius

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

Vital signs - weight, in kilograms

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

Vital signs - blood pressure: systolic/diastolic

Safety will be assessed at each visit (heart rate: bpm)

Vital signs - heart rate: bpm

Safety will be assessed at each visit (AST, ALT, ALP, GGT units per liter (U/L)

Abnormal laboratory parameters liver function (AST, ALT, ALP, GGT units per liter (U/L)

Safety will be assessed at each visit total bilirubin - milligrams per deciliter (mg/dL)

Abnormal laboratory parameters liver function total bilirubin - milligrams per deciliter (mg/dL)

Safety will be assessed at each visit (urea and creatinine - mmol/L)

Abnormal laboratory parameters kidney function (urea and creatinine - mmol/L)

Safety will be assessed at each visit (full blood count - 109/L)

Abnormal laboratory parameters full blood count - 109/L

Changes in the absolute numbers of T, B and NK (Natural Killer) cells.

Change in HbA1c and daily insulin requirements during the trial period.

Full Information

NCT ID

NCT03782636

First Posted

September 7, 2018

Last Updated

December 15, 2021

Sponsor

University of Oxford

Collaborators

Oxford Clinical Trials Research Unit (OCTRU), Centre for Statistics in Medicine, Oxford, Juvenile Diabetes Research Foundation, Wellcome

1. Study Identification

Unique Protocol Identification Number

NCT03782636

Brief Title

Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

Acronym

ITAD

Official Title

Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 28, 2019 (Actual)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

Collaborators

Oxford Clinical Trials Research Unit (OCTRU), Centre for Statistics in Medicine, Oxford, Juvenile Diabetes Research Foundation, Wellcome

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Investigators know that the longer people with diabetes can produce their own insulin, the better it is for the control of their blood glucose levels and long-term complications. People get type 1 diabetes because their immune system, the part of the body, which helps fight infections, mistakenly attacks and destroys the beta cells in the pancreas that produce insulin. As the immune system destroys these insulin-producing cells, the body's own ability to produce insulin decreases and diabetes develops. At diagnosis, there are usually a small number of beta cells (10-20%) left in the pancreas, which still produce small amounts of insulin. This is called 'beta cell function' and it is assessed by measuring C-peptide, which is a protein made by the pancreas when insulin is produced. Most people with type 1 diabetes eventually stop producing insulin themselves, this may occur rapidly in a few months, or more slowly over several years. New treatments preserving insulin production could improve management of diabetes. This could be done by using drugs acting on cells of the immune system. In type 1 diabetes, there is an imbalance between cells of the immune system, and there is evidence that one protein produced by our body, called Interleukin-2, could help in resetting the balance between those cells. It is important to start this treatment soon after diagnosis because this when there is the best chance of saving the beta cells still left in the pancreas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aldesleukin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aldesleukin

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

sterile diluent used for the aldesleukin preparation and 5% glucose

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

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

Title

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

Description

Assessment of the most commonly reported reactions to low- or high-dose aldesleukin, namely influenza-like syndrome, skin reaction, diarrhoea, nausea using CTCAE grading v5.0

Time Frame