Trial Outcomes & Findings for Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes (NCT NCT02641522)
NCT ID: NCT02641522
Last Updated: 2018-11-02
Results Overview
Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
10 participants
Primary outcome timeframe
0-to-12 weeks
Results posted on
2018-11-02
Participant Flow
Participant milestones
| Measure |
Siltuximab
Single infusion of siltuximab (11 mg/kg)
Siltuximab: Single infusion of siltuximab (11 mg/kg)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Siltuximab
n=10 Participants
Single infusion of siltuximab (11 mg/kg)
Siltuximab: Single infusion of siltuximab (11 mg/kg)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-to-12 weeksPopulation: 1 participant was excluded from analysis because of technical problems with processing samples.
Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline
Outcome measures
| Measure |
Siltuximab
n=9 Participants
Single infusion of siltuximab (11 mg/kg)
Siltuximab: Single infusion of siltuximab (11 mg/kg)
|
|---|---|
|
Percent Change From Baseline in IL-6 Stimulated Intracellular p-STAT3 at Week 12
|
-4.31 Percent change from Baseline
Standard Deviation 15.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-to-12 weeksMonitor adverse events associated with siltuximab treatment. All AE related to study drug will be tabulated along with their grade.
Outcome measures
Outcome data not reported
Adverse Events
Siltuximab
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Siltuximab
n=10 participants at risk
Single infusion of siltuximab (11 mg/kg)
Siltuximab: Single infusion of siltuximab (11 mg/kg)
|
|---|---|
|
Investigations
Nuetrophil count decreased
|
10.0%
1/10 • 0-to-12 weeks
|
Other adverse events
| Measure |
Siltuximab
n=10 participants at risk
Single infusion of siltuximab (11 mg/kg)
Siltuximab: Single infusion of siltuximab (11 mg/kg)
|
|---|---|
|
Investigations
Nuetrophil count decreased
|
60.0%
6/10 • 0-to-12 weeks
|
|
Investigations
White blood cell decreased
|
20.0%
2/10 • 0-to-12 weeks
|
|
Investigations
Lymphocyte count decreased
|
20.0%
2/10 • 0-to-12 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10 • 0-to-12 weeks
|
|
Infections and infestations
Upper respiratory infection
|
30.0%
3/10 • 0-to-12 weeks
|
|
Infections and infestations
Infections and infestations - Other - chalazion
|
10.0%
1/10 • 0-to-12 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
1/10 • 0-to-12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • 0-to-12 weeks
|
|
Gastrointestinal disorders
Dental caries
|
10.0%
1/10 • 0-to-12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • 0-to-12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • 0-to-12 weeks
|
Additional Information
Sarah Robinson/ Administrative Assistant
Benaroya Research Institute
Phone: (206) 342-6931
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place