NCT02641522

Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Carla Greenbaum, MD · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Siltuximab	Single infusion of siltuximab (11 mg/kg)

Timeline

• Start date: 2016-03-08
• Primary completion: 2017-03-16
• Completion: 2017-03-16
• First posted: 2015-12-29
• Last updated: 2018-11-02
• Results posted: 2018-10-09

Locations

1 site across 1 country: United States