Pilot Clinical Trial of Ustekinumab in Patients With New-onset T1D

Sponsor
University of British Columbia
Study ID
NCT02117765
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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. This is a pilot clinical trial to test the safety of a drug, ustekinumab, in 20 adult subjects with recent-onset T1D. Ustekinumab is currently licensed for use in psoriasis where it has proven to be both highly effective and safe and so the investigators hope to see a similar effect in T1D. This trial will also be used to determine the best dosage and frequency of the drug to be given to people with T1D to help design future studies on the drug's effectiveness. 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.

Key Dates

Start date
Mar 31, 2015
Status verified
May 2016
Primary completion
Feb 28, 2017
Completion
Jun 30, 2017

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Four cohorts of 5 subjects will be recruited: Group 1: Five subjects will be given Ustekinumab 45mg SC at 0, 4, 16, 28 and 40 weeks. Group 2: Five subjects will be given Ustekinumab 90mg SC at 0, 4, 16, 28 and 40 weeks. Group 3: Five subjects will be given Ustekinumab 45 mg SC at 0,4 and 16 weeks. Group 4: Five subjects will be given Ustekinumab 90mg SC at 0, 4 and 16 weeks.

Primary Outcome Measure

Primary Safety Endpoints (composite outcome measure) [ Time Frame: 12 months ]

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