Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes

NCT02641522 | Completed Early Phase 1 Results

• 1 other identifier: EMU-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes

Keywords

T1D; Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in IL-6 Stimulated Intracellular p-STAT3 at Week 12

  Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline

  0-to-12 weeks

Other Outcomes (1)

• Adverse Event Monitoring

  0-to-12 weeks

Study Arms (1)

Post-Infusion

EXPERIMENTAL

Single infusion of siltuximab (11 mg/kg)

Drug: Siltuximab

Interventions

Siltuximab DRUG

Single infusion of siltuximab (11 mg/kg)

Also known as: Sylvant

Post-Infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Carla Greenbaum, MD: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Benaroya Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

siltuximab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Sarah Robinson/ Administrative Assistant
• Organization: Benaroya Research Institute

diabetes@benaroyaresearch.org

(206) 342-6931

Study Officials

• Carla Greenbaum, MD

  Benaroya Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Diabetes Program

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 29, 2015
• Study Start: March 8, 2016
• Primary Completion: March 16, 2017
• Study Completion: March 16, 2017
• Last Updated: November 2, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-10

Locations

US (1)