- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02641522
Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes
October 5, 2018 updated by: Carla Greenbaum, MD
The purpose of this study is to evaluate the effects of siltuximab on immune cell functions in patients with Type 1 diabetes (T1D).
Study Overview
Detailed Description
This is an open-label (all people know the identity of the intervention), single center, non-randomized (patients are not assigned by chance to treatment groups), Mechanistic Study (a study that focuses on the biologic activity of the drug, rather than on disease treatment).
Up to 10 patients with Type 1 diabetes (T1D) will be enrolled in the study.
Participants will receive a single dose of siltuximab and blood samples will be obtained a total of 6 times until 12 weeks after dosing.
Cells will be isolated from the blood samples and used to measure specific activities of cells in the immune system.
Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study.
The end of study is the date of the last assessment for the last patient.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98101
- Benaroya Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Positive for at least one diabetes-related autoantibody any time since diagnosis, including by not limited to: Glutamate decarboxylase (GAD-65) Insulin, if obtained within 10 days of the onset of exogenous insulin therapy; IA-2; ZnT8
- Peak stimulated C-peptide level ≥ 0.1 pmol/mL following a mixed meal tolerance test (MMTT) conducted within 60 days of enrollment
- Females of child-bearing potential must be willing to use effective birth control and refrain from donating eggs for the purposes of assisted reproduction for duration of study.
- A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at screening and prior to dosing.
- During the study, and for 3 months after receiving the study agent, a woman must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction.
- Willing and able to give informed consent for participation.
Exclusion Criteria:
- History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies;
- History of malignancy or serious uncontrolled cardiovascular disease or hypertension, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia despite therapy;
- Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections;
- History or serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C;
- Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection;
- Active infection with EBV ;
- Active infection with CMV;
- Diagnosis of liver disease or elevated hepatic enzymes, confirmed by repeat tests, as defined by ALT, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > ULN;
Any of the following hematologic abnormalities, confirmed by repeat tests:
- White blood count <3,000/μL or >14,000/μL
- Lymphocyte count <500/μL
- Platelet count <150,000 /μL
- Hemoglobin <8.5 g/dL or > or = to 17 g/dL
- Neutrophil count <2,000 cells/μL
- Females who are pregnant or lactating;
- Receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guérin, and small pox) in the 6 weeks before treatment;
- Receipt of non-live vaccine in the 4 weeks before treatment;
- Any medical or psychological condition that in the opinion of the Sponsor Investigator would interfere with the safe completion of the trial;
- Receipt of an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months or 5 half-lives before enrollment or is currently enrolled in the treatment stage of an investigational study;
- Receipt of any immune-modulating biologic drug within 3 months of enrolling in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Post-Infusion
Single infusion of siltuximab (11 mg/kg)
|
Single infusion of siltuximab (11 mg/kg)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in IL-6 Stimulated Intracellular p-STAT3 at Week 12
Time Frame: 0-to-12 weeks
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Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline
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0-to-12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Event Monitoring
Time Frame: 0-to-12 weeks
|
Monitor adverse events associated with siltuximab treatment.
All AE related to study drug will be tabulated along with their grade.
|
0-to-12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carla Greenbaum, MD, Benaroya Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2016
Primary Completion (Actual)
March 16, 2017
Study Completion (Actual)
March 16, 2017
Study Registration Dates
First Submitted
December 23, 2015
First Submitted That Met QC Criteria
December 28, 2015
First Posted (Estimate)
December 29, 2015
Study Record Updates
Last Update Posted (Actual)
November 2, 2018
Last Update Submitted That Met QC Criteria
October 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMU-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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