Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Centre for Statistics in Medicine, Oxford; JDRF; Juvenile Diabetes Research Foundation; Oxford Clinical Trials Research Unit (OCTRU); Wellcome
• Treatments: Aldesleukin; Interleukin-2

Criteria

Inclusion Criteria:

1. Have given written informed consent to participate or assent with parental consent

2. Be aged 6-18 years

3. Be diagnosed with T1D (Type 1 Diabetes) (at least one autoantibody positive), requiring insulin treatment

4. Be within 6 weeks from diagnosis of T1D (at screening)

5. Have a random C-peptide > 200 pmol/l

6. Normal full blood count

Exclusion Criteria:

1. Non-type 1 diabetes (type 2 or monogenic diabetes) and secondary diabetes

2. Pre-existing autoimmune disease (excluding type 1 diabetes)

3. Hypersensitivity to aldesleukin or any of the excipients

4. History of severe cardiac disease (NYHA Class III or IV)

5. History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)

6. Clinically significant abnormal laboratory values (out of range and associated with clinical symptoms or signs) in haematology, biochemistry, thyroid, liver and kidney function

7. Pre-existing severe major organ dysfunction or seizure disorders

8. Participation in another clinical trial (CTIMP) within 4 months prior to screening

9. Females who are pregnant, lactating or intend to get pregnant during the study

10. Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial

11. Sexually active males who are unwilling or unable to comply with contraceptive advice

12. Current use of immunosuppressive agents or steroids

13. Current treatment with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic products

14. 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

15. 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

16. Children with compliance problems (families where the local investigators consider that problems with compliance may be an issue)