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Trial record 15 of 2360 for:    "Diabetes Mellitus, Insulin-Dependent"

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 : November 2, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Carla Greenbaum, MD, Benaroya Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Type 1 Diabetes
Intervention Drug: Siltuximab
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Siltuximab
Hide Arm/Group Description

Single infusion of siltuximab (11 mg/kg)

Siltuximab: Single infusion of siltuximab (11 mg/kg)

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Siltuximab
Hide Arm/Group Description

Single infusion of siltuximab (11 mg/kg)

Siltuximab: Single infusion of siltuximab (11 mg/kg)

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
27.1  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
  10.0%
Black or African American
0
   0.0%
White
9
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Percent Change From Baseline in IL-6 Stimulated Intracellular p-STAT3 at Week 12
Hide Description Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline
Time Frame 0-to-12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant was excluded from analysis because of technical problems with processing samples.
Arm/Group Title Siltuximab
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Single infusion of siltuximab (11 mg/kg)

Siltuximab: Single infusion of siltuximab (11 mg/kg)

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: Percent change from Baseline
-4.31  (15.99)
2.Other Pre-specified Outcome
Title Adverse Event Monitoring
Hide Description Monitor adverse events associated with siltuximab treatment. All AE related to study drug will be tabulated along with their grade.
Time Frame 0-to-12 weeks
Outcome Measure Data Not Reported
Time Frame 0-to-12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Siltuximab
Hide Arm/Group Description

Single infusion of siltuximab (11 mg/kg)

Siltuximab: Single infusion of siltuximab (11 mg/kg)

All-Cause Mortality
Siltuximab
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Siltuximab
Affected / at Risk (%)
Total   1/10 (10.00%) 
Investigations   
Nuetrophil count decreased  1  1/10 (10.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Siltuximab
Affected / at Risk (%)
Total   10/10 (100.00%) 
Gastrointestinal disorders   
Gastroesophageal reflux disease  1  1/10 (10.00%) 
Diarrhea  1  1/10 (10.00%) 
Dental caries  1  1/10 (10.00%) 
Infections and infestations   
Upper respiratory infection  1  3/10 (30.00%) 
Infections and infestations - Other - chalazion  1  1/10 (10.00%) 
Investigations   
Nuetrophil count decreased  1  6/10 (60.00%) 
White blood cell decreased  1  2/10 (20.00%) 
Lymphocyte count decreased  1  2/10 (20.00%) 
Metabolism and nutrition disorders   
Hypoglycemia  1  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/10 (10.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sarah Robinson/ Administrative Assistant
Organization: Benaroya Research Institute
Phone: (206) 342-6931
Responsible Party: Carla Greenbaum, MD, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT02641522     History of Changes
Other Study ID Numbers: EMU-002
First Submitted: December 23, 2015
First Posted: December 29, 2015
Results First Submitted: March 1, 2018
Results First Posted: October 8, 2018
Last Update Posted: November 2, 2018