Summary
The USTEKID trial ran in 16 sites in the UK. It opened to recruitment in Dec 2018 and successfully recruited all 72 patients who were randomised to receive either ustekinumab or saline control in a 2:1 ratio.
Our recruitment video can be found at https://www.youtube.com/watch?v=8kuCefuBSW4
More details about the trial design and a detailed summary of the results can be found at https://www.isrctn.com/ISRCTN14274380
In summary, the trial found that:
- Participants treated with ustekinumab had 49% higher levels of MMTT stimulated C-peptide at week 52 (primary end point) than those treated with the control
- Ustekinumab was very well tolerated with no treatment-related withdrawals
- Stabilisation of C-peptide loss appeared to occur late (between weeks 28 and 52)
- C-peptide preservation from weeks 28-52 was correlated with reduction in a highly specific subset of T cells expressing the cytokines IL-17, interferon gamma, IL-2 and GMCSF, representing as few as 0.1% of circulating CD4 T cells
- No significant differences in metabolic endpoints or PROMs were seen between the groups although the study was not powered for these end points
- Ustekinumab appears to slow the autoimmune process providing the first clinical trial evidence that IL-17 secreting T cells play a pathogenic role in T1D. Alone, it is insufficient to halt the autoimmune process. Consideration may be given to testing other drugs targeting the IL-17 pathway, using ustekinumab in combination with other agents or using it earlier in the disease pathway (preclinical disease) since it is so well tolerated and simple to use
Contact Details
Trial Manager / Lead Contact: Dr Kym Carter
Phone: 01792 606372
Email: k.carter@swansea.ac.uk
Website: https://www.swansea.ac.uk/staff/medicine-health-life-science/medicine/health-data-science/carter-k/
Twitter: https://twitter.com/kymberleycarter
ISCRTN Number: 14274380 ; IRAS ID: 23011;