Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years

NCT03179423 | Completed Phase 2 DMC

• 1 other identifier: GNC-301
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE)

  Serious Adverse Events (SAE) and Adverse Events (AE)

  Week 1 to 24/48

Study Arms (2)

GNbAC1

EXPERIMENTAL

Monthly IV repeated dose

Drug: GNbAC1

Placebo

PLACEBO COMPARATOR

Monthly IV repeated dose

Drug: Placebo

Interventions

GNbAC1 DRUG

Monthly IV repeated dose

GNbAC1

Placebo DRUG

Monthly IV repeated dose

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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 \[ICA\]).

You may not qualify if:

• Subjects with type 2 diabetes;
• Pregnant and nursing women.

Sponsors & Collaborators

• GeNeuro Australia PTY Ltd: lead
• Southern Star Research: collaborator

Study Sites (13)

Macquarie University Hospital

Macquarie University, New South Wales, Australia

Location

AIM Centre

Merewether, New South Wales, Australia

Location

Northern Sydney Local Health District - Royal North Shore Hospital

St Leonards, New South Wales, Australia

Location

Ipswich Research Centre

Ipswich, Queensland, Australia

Location

Mater Misericordiae Ltd and Mater Medical Research Institute Limited

South Brisbane, Queensland, Australia

Location

Gold Coast Hospital and Health Service

Southport, Queensland, Australia

Location

Southern Adelaide Local Health Network - Repatriation General Hospital

Adelaide, South Australia, Australia

Location

Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Location

Eastern Health

Box Hill, Victoria, Australia

Location

St Vincent's Hospital (Melbourne) Limited

Fitzroy, Victoria, Australia

Location

Barwon Health - University of Geelong

Geelong, Victoria, Australia

Location

Heidelberg Repatriation Hospital

Heidelberg, Victoria, Australia

Location

Keogh Institute of Medical Research

Nedlands, Western Australia, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

temelimab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The first part of the trial is double-blind and the second part is open-label with all participants receiving the active treatment.

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 7, 2017
• Study Start: June 14, 2017
• Primary Completion: September 1, 2018
• Study Completion: May 7, 2019
• Last Updated: October 20, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (13)