Trial | NCT03179423  Report issue

Title

Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Randomised, Double-Blind, Placebo-Controlled Study to Investigate GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    gnbac1 ...

  • Study Participants

    64
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.
Study Started
Jun 14
2017
Primary Completion
Sep 01
2018
Study Completion
May 07
2019
Last Update
Oct 20
2020

Drug GNbAC1

Monthly IV repeated dose

Drug Placebo

Monthly IV repeated dose

GNbAC1 Experimental

Monthly IV repeated dose

Placebo Placebo Comparator

Monthly IV repeated dose

Criteria 

Main Inclusion Criteria:

Subjects diagnosed with type 1 diabetes in the 4 years prior to signed informed consent;
Peak stimulated C-peptide of ≥0.2 nmol/L during a mixed meal tolerance test performed during the Screening period;
18 to 55 years of age (both inclusive);
Body weight >40 to ≤100 kg;
Subjects positive for at least one diabetes-associated autoantibody (insulin, glutaminic-acid-decarboxylase-65 [GAD-65], tyrosine phosphatase-related antigen 2 [IA-2], ZnT8 or islet-cell antibody [ICA]).

Main Exclusion Criteria:

Subjects with type 2 diabetes;
Pregnant and nursing women.
No Results Posted