Clinical trial NCT03179423: Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Official title: Randomised, Double-Blind, Placebo-Controlled Study to Investigate GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 1
Keywords: Diabetes Mellitus, Type 1
T1D
Monoclonal antibody
Multiple Sclerosis associated retrovirus MSRV
Human Endogenous Retrovirus Type W (HERV-W)
GNbAC1
Temelimab
Lead sponsor: GeNeuro SA
Sponsor class: INDUSTRY
Collaborators: name: Southern Star Research
First posted: 2017-06-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first part of the trial is double-blind and the second part is open-label with all participants receiving the active treatment.
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE)
timeFrame: Week 1 to 24/48
Secondary outcomes:
Other outcomes:
Locations:
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Merewether
country: Australia
facility: AIM Centre
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Sydney Local Health District - Royal North Shore Hospital
state: New South Wales
city: Ipswich
country: Australia
facility: Ipswich Research Centre
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd and Mater Medical Research Institute Limited
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Hospital and Health Service
state: Queensland
city: Adelaide
country: Australia
facility: Southern Adelaide Local Health Network - Repatriation General Hospital
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital (Melbourne) Limited
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health - University of Geelong
state: Victoria
city: Heidelberg
country: Australia
facility: Heidelberg Repatriation Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Keogh Institute of Medical Research
state: Western Australia
Study officials:
References: