Pilot Clinical Trial of Ustekinumab in Patients With New-onset T1D (UST1D)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Ustekinumab in Patients With New-onset Type 1 Diabetes|
- Primary Safety Endpoints (composite outcome measure) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Rate, frequency and severity of all adverse events including; hypoglycemic episodes; injection reactions; hypersensitivity reactions; evidence of infection and posterior leukoencephalopathy syndrome.
- Vital signs, standard hematology and chemistry tests, physical examinations.
- Immunological Endpoints (composite outcome measure) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Immune phenotyping via flow cytometry of all Interleukin (IL)-12, IL-23, IL-17, Interferon(IFN)-γ secreting immune subsets.
- Basic immune phenotyping of white blood cell subsets.
- Human leukocyte antigen(HLA)- A, B, C, DR, DP, DQ typing.
- Fluorospot (ELISpot) analysis for IL-17 and IFN-γ secretion in response to whole insulin and antigens for Cluster of differentiation (CD)8+ and CD4+ T cells .
- Luminex assessment of serum cytokines IL-17, IFN-γ, IL-12 and IL-23.
- Regulatory T cell : Effector T cell ratio
- CD154 based assays to determine diabetogenic antigen specific responses of T helper cells.
- Epigenetic assessment of Treg phenotype and function.
- Exploratory (composite outcome measure) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Mixed-meal tolerance test (MMTT) - stimulated 2-hour C-peptide area under the curve (AUC) at weeks 4, 28 and 52.
- Insulin use in units per kg body weight per day at weeks 4, 16, 28, 40 and 52.
- HbA1C levels at weeks 4, 16, 28, 40 and 52.
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
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.
Other Name: Stelara
Please refer to this study by its ClinicalTrials.gov identifier: NCT02117765
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Jan Dutz, MD FRCPC||Professor Department of Dermatology and Skin Science University of British Columbia|
|Study Director:||Ashish Marwaha, BMBCh PhD||University of British Columbia|
|Study Director:||Annika Sun, MSc||University of British Columbia|