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Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02641522
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Carla Greembaum, MD, Benaroya Research Institute

Brief Summary:
The purpose of this study is to evaluate the effects of siltuximab on immune cell functions in patients with Type 1 diabetes (T1D).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Siltuximab Early Phase 1

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  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : March 16, 2017
Actual Study Completion Date : March 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Siltuximab

Arm Intervention/treatment
Experimental: Post-Infusion
Single infusion of siltuximab (11 mg/kg)
Drug: Siltuximab
Single infusion of siltuximab (11 mg/kg)
Other Name: Sylvant




Primary Outcome Measures :
  1. Immune Responses to IL-6 [ Time Frame: 0-to-12 weeks ]
    Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Peak stimulated C-peptide level ≥ 0.1 pmol/mL following a mixed meal tolerance test (MMTT) conducted within 60 days of enrollment
  3. 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.
  4. 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.
  5. 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.
  6. Willing and able to give informed consent for participation.

Exclusion Criteria:

  1. History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies;
  2. History of malignancy or serious uncontrolled cardiovascular disease or hypertension, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia despite therapy;
  3. Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections;
  4. History or serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C;
  5. Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection;
  6. Active infection with EBV ;
  7. Active infection with CMV;
  8. 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;
  9. 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
  10. Females who are pregnant or lactating;
  11. 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;
  12. Receipt of non-live vaccine in the 4 weeks before treatment;
  13. Any medical or psychological condition that in the opinion of the Sponsor Investigator would interfere with the safe completion of the trial;
  14. 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;
  15. Receipt of any immune-modulating biologic drug within 3 months of enrolling in the study.

Information from the National Library of Medicine

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): NCT02641522


Locations
United States, Washington
Benaroya Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Carla Greembaum, MD
Janssen Research & Development, LLC
Investigators
Principal Investigator: Carla Greenbaum, MD Benaroya Research Institute
  Study Documents (Full-Text)

Documents provided by Carla Greembaum, MD, Benaroya Research Institute:

Responsible Party: Carla Greembaum, MD, Director, Diabetes Program, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT02641522     History of Changes
Other Study ID Numbers: EMU-002
First Posted: December 29, 2015    Key Record Dates
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Carla Greembaum, MD, Benaroya Research Institute:
T1D
Type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Siltuximab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs