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

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

January 4, 2021

Primary Completion Date

February 1, 2026

Study Completion Date

November 1, 2026

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

Ustekinumab

"Week 0: Loading dose of 6mg/kg Ustekinumab Intravenously.~Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg Ustekinumab subcutaneously."

DRUG

Placebo

"Patients allocated to receive placebo will receive respective amounts of a saline-placebo at the same intervals.~Week 0: Loading dose of 6mg/kg saline intravenously.~Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg saline subcutaneously."

Trial Locations (2)

M5T 3L9

Mount Sinai Hospital/UHN, Toronto

V5Y 3W2

BCDiabetes, Vancouver

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

Janssen, LP

INDUSTRY

lead

University of British Columbia

OTHER