Pilot Clinical Trial of Ustekinumab in Patients With New-onset T1D (UST1D)
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|ClinicalTrials.gov Identifier: NCT02117765|
Recruitment Status : Unknown
Verified May 2016 by University of British Columbia.
Recruitment status was: Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : May 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Ustekinumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Ustekinumab in Patients With New-onset Type 1 Diabetes|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||June 2017|
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
- Primary Safety Endpoints (composite outcome measure) [ Time Frame: 12 months ]
- 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 ]
- 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 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|