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

Diabetes Mellitus Type 1 Clinical Trial

— RAINBOW-T1D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179423
• Other study ID #: GNC-301
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2017
• Est. completion date: May 7, 2019

Study information

• Verified date: May 2019
• Source: GeNeuro SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 7, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Drug:
• GNbAC1
Monthly IV repeated dose
• Placebo
Monthly IV repeated dose

Locations

Country	Name	City	State
Australia	Southern Adelaide Local Health Network - Repatriation General Hospital	Adelaide	South Australia
Australia	Eastern Health	Box Hill	Victoria
Australia	Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	St Vincent's Hospital (Melbourne) Limited	Fitzroy	Victoria
Australia	Barwon Health - University of Geelong	Geelong	Victoria
Australia	Heidelberg Repatriation Hospital	Heidelberg	Victoria
Australia	Ipswich Research Centre	Ipswich	Queensland
Australia	Macquarie University Hospital	Macquarie University	New South Wales
Australia	AIM Centre	Merewether	New South Wales
Australia	Keogh Institute of Medical Research	Nedlands	Western Australia
Australia	Mater Misericordiae Ltd and Mater Medical Research Institute Limited	South Brisbane	Queensland
Australia	Gold Coast Hospital and Health Service	Southport	Queensland
Australia	Northern Sydney Local Health District - Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
GeNeuro Australia PTY Ltd	Southern Star Research Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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