Ustekinumab was approved in the US in 2009 for treating psoriasis, which is an autoimmune disease (where the immune system self attacks skin cells rather than pancreas cells, as with type-1). It has also been tested on multiple sclerosis, Crohn's disease, and sarcoidosis (also all autoimmune diseases). Ustekinumab is thought to work by blocking inflammation, and specifically blocking two immune molecules called IL-12 and IL-23.
The USTEKID Trial
This trial will enroll 72 adolescent (aged 12-18) honeymooners (within 100 days of diagnosis). 2/3s of them will get the drug (an infusion of Ustekinumab) once every two months for almost a year, and the other 1/3 will get a placebo, as a control group. The study will use C-peptide in response to a meal as a primary end point (measured one year after start of treatment). There are also a bunch of secondary end points.
The first patient started the trial in Dec-2018 and they hope to finish by Oct-2022.
Web site: https://www.type1diabetesresearch.org.uk/current-trials/
European Clinical Trial Registration: http://www.isrctn.com/ISRCTN14274380
EudraCT number: 2018-000015-24
Primary contact: Dr Kym Thorne
Floor 2, ILS2, Swansea University Medical School
Swansea, SA2 8PP, United Kingdom
+44 (0)1792 606372 email@example.com
(Note that not all sites are recruiting all ages, and not all have opened as yet.)
- Royal Aberdeen Children’s Hospital, Westburn Road, Aberdeen, AB25 2ZG
- Countess of Chester Hospital, Liverpool Road, Chester, CH2 1UL
- Tayside Children's Hospital, Ninewells Hospital, Dundee, DD1 9SY
- Royal Devon and Exeter Hospital, Barrack Road, Exeter, EX2 5DW
- Royal London Hospital (Barts), Whitechapel Road Whitechapel, London, E1 1BB
- University College Hospital London, 250 Euston Road, London, NW1 2PG
- University Hospital of Wales, Heath Park, Cardiff, CF14 4XW
- Noah’s Ark Children’s Hospital of Wales, Heath Park, Cardiff, CF14 4XW
- Evelina Children’s Hospital, St Thomas' Hospital, Westminster Bridge Road, London , SE1 7EH
- St James’ Hospital, Beckett Street, Leeds, LS9 7TF
This study is supported by National Institute for Health Research (NIHR) (UK), and is part of the ADDRESS-2 network, which is funded by JDRF.
Other Ustekinumab Studies
You can read my previous blogging on Ustekinumab here:
Both of these studies have the same warning signal. Both completed over a year ago, but have not yet published their results. My experience is that studies which are successful publish quickly, usually within a year of completion, so the fact that these researchers have not yet published is a bad sign.
Ustekinumab and INGAP
A small combination study of Ustekinumab and INGAP started in November 2015 and ended in March 2017, but the results have not yet been published.
Phase-I Clinical Trial For Ustekinumab
A 20 person phase-I trial for Ustekinumab started recruiting in March 2015 and finished recruiting in May 2016 and therefore should have completed after May 2017, but the results have not yet been published.
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All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.