Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2)

In type 1 diabetes (T1D), immune defense cells in the body attack and destroy insulin-producing beta cells leaving affected people with a lifelong need for daily insulin injections. Even with insulin injections, blood glucose (sugar) control is imperfect and leads to many health complications and a shortened life span. Our pilot study (NCT02117765) has informed us that Ustekinumab is safe in the treatment of participants with recent-onset T1D. Ustekinumab is currently licensed for use in psoriasis where it has proven to be both highly effective and safe. The investigators hope that if the drug can block immune cells soon after the development of diabetes, any remaining insulin-producing cells may be protected, and regenerate, thus producing more insulin so that individuals may be insulin free, or require less insulin. This trial will assess the efficacy of Ustekinumab in decreasing C-peptide decline (proxy for endogenous insulin production) in participants with recent onset T1D.

NCT Number	NCT03941132
Lead Sponsor	University of British Columbia Collaborators: Juvenile Diabetes Research Foundation, Janssen, LP
Conditions	Type 1 Diabetes Mellitus
Enrollment	66 participants
Start Date	2021-01-04
Primary Completion	2026-02-01 (estimated)
Study Completion	2026-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-02-24