Phase II multi-centre, double-blind, randomised trial of ustekinumab in adolescents with new-onset type 1 diabetes

Cardiff University0 sites88 target enrollmentAugust 24, 2018

Overview

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34663658/ (added 15/08/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39079992/ (added 31/07/2024)

Registry

who.int

Start Date

August 24, 2018

End Date

October 31, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Current inclusion criteria as of 10/12/2019:
•1\. Clinical diagnosis of immune\-mediated Type 1 diabetes mellitus as defined by American Diabetes Association
•2\. Commenced on insulin within 1 month of clinical diagnosis (defined as confirmed raised blood sugar (ADA criteria), not symptoms alone).
•3\. An interval of \=100 days between the confirmed diagnosis (defined as first insulin dose) and the first dose of the IMP
•4\. Written and witnessed informed consent/assent to participate
•5\. Male or female, aged 12\-18 years inclusive at the time of randomisation
•6\. Evidence of residual functioning beta\-cells (serum C\-peptide level \> 0\.2nmol/L in the MMTT test)
•7\. Positive for at least one islet autoantibody (GAD, IA\-2, ZnT8\)
•8\. Body weight \< 100 kg
•9\. Willing to record all insulin doses and blood glucose levels required for monitoring during the study, including reporting any hypoglycaemic events.

•Current exclusion criteria as of 10/12/2019:
•1\. Breastfeeding, pregnancy or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial
•2\. Prior exposure to Ustekinumab within 3 months of the first dose of IMP
•3\. Use of more than 10 mg prednisolone daily (or equivalent) for \>5 days within 3 months of the first dose of IMP. Note: intranasal, inhaled and topical corticosteroid medications are permitted at recommended doses. Use of systemic corticosteroids during the trial should be avoided unless such treatment is medically necessary and alternative treatments are not considered safe or effective
•4\. Prior exposure to any anti\-lymphocyte monoclonal antibody, such as anti\-CD20, anti\-thymocyte globulin (ATG), Rituximab (Rituxan®), or Alemtuzumab (Campath®)
•5\. Use of immunosuppressive or immunomodulatory therapies, including systemic steroids (e.g., methotrexate, cyclosporine, or anti\-TNF agents) within 30 days prior to receiving the first dose and/or intent on using any monoclonal antibody therapy given for any indication for the duration (including follow up) of the trial
•6\. Use of any hypoglycaemia agents other than insulin, for more than 6 weeks, at any time prior to trial entry, including SGLT2 inhibitors.
•7\. Use of inhaled insulin
•8\. Known alcohol abuse, drug abuse
•9\. Evidence of active Hepatitis B, Hepatitis C, HIV or considered by the investigator to be at high risk for HIV infection