drugset / Trial / NCT02204397

Study of Tolerability and Safety of Adding Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With TD1 Melitis

NCT02204397

Phase 2 Completed 5 enrolled Jewish General Hospital
NaSingle-groupOpen-labelTreatment

Summary

A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in patients with established T1DM.

Timeline

Start
2015-11
Primary completion
2017-03-08
Completion
2017-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject INGAP Peptide Peptide 600 mg Subcutaneous
Subject Ustekinumab Monoclonal antibody 45 mg Subcutaneous