Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Status:
Completed
Trial end date:
2019-05-07
Target enrollment:
Participant gender:
Summary
The monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous
Multiple Sclerosis associated RetroVirus (MSRV), which could play a critical role in
different autoimmune disorders, notably type 1 diabetes (T1D).
This study is a multicentre study evaluating for the first time the safety and efficacy of
GNbAC1 in T1D subjects for a first bouble-blind period of 20 weeks followed by an optional
open-label period of 24 weeks. The primary objective of the study is to assess the safety and
tolerability of six consecutive 4-weekly doses of GNbAC1 in subjects with T1D. Secondary
objectives are to determine the pharmacodynamic response to GNbAC1 on biomarkers of T1D.