A lot of autoimmune diseases have disease-modifying therapies, which are treatments that can slow, halt, and reverse disease progression. Rheumatoid arthritis. Lupus. Multiple sclerosis.
What isn’t on the list? Type 1 diabetes (T1D). T1D remains one of the only major autoimmune diseases that does not have a licensed disease-modifying therapy.
Clinical Trial Overview
The investigators will test the hypothesis that simultaneous inhibition of two immune cell pathways—interleukin-17 and interferon-gamma, which are thought to drive T1D—will halt the progression of, or reverse, disease in participants with recent-onset T1D.
The hope is that, if the drug can block immune cells soon after the development of diabetes, any remaining insulin-producing cells may be protected and regenerate, producing more insulin so that people with T1D may be insulin free or require less insulin for a longer period of time.
How will they do that?
With a drug called ustekinumab (oos·teh·KIN·yoo·mab). Ustekinumab—made by Janssen and sold under the name Stelara® for the treatment of psoriasis (which affects the skin), Crohn’s disease (an inflammatory bowel disease), and other autoimmune conditions—is a monoclonal antibody that inhibits two molecules that regulate the immune system.
It’s already approved, meaning that, if the clinical trial results are positive, translation to clinical use would not only be feasible, but rapid.
Where will it take place and how many will be recruited?
The phase II/III trial is taking place at BCDiabetes in Vancouver, under the leadership of Tom Elliott, MBBS, and the University of Toronto, under Bruce Perkins, M.D., MPH, both in Canada. There will be a total of 60 participants, ages 18-25, enrolled.
There is also a trial testing ustekinumab in teens, aged 12-18, within 100 days of diagnosis, in various locations of the United Kingdom, and a JDRF grant to Megan Levings, Ph.D., at the BC Children’s Hospital Research Institute, will harmonize the biomarkers of response in both of the clinical trials, thereby increasing the sample size and more rapidly identifying whether or not this is an effective therapy for T1D.
What were the results of other clinical trials of ustekinumab in T1D?
The pilot study by Jan Dutz, M.D.—who is also the lead on the phase II/III study—showed that ustekinumab is safe in the treatment of participants with recent-onset T1D.
How will I learn more?
You can contact Marla Inducil, B.Sc. Pharm, M.D., CCRP, at 604-628-7253 ext. 7011 or firstname.lastname@example.org. She is responsible for managing and executing all clinical trials at BCDiabetes located in Vancouver.