RAINBOW-T1D: Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years

Sponsor

GeNeuro Australia PTY Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT03179423

Collaborator

Southern Star Research Pty Ltd. (Other)

Enrollment

Locations

Arms

22.7

Actual Duration (Months)

4.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 1	Drug: GNbAC1 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 14, 2017

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

May 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GNbAC1 Monthly IV repeated dose	Drug: GNbAC1 Monthly IV repeated dose
Placebo Comparator: Placebo Monthly IV repeated dose	Drug: Placebo Monthly IV repeated dose

Arm

Intervention/Treatment

Experimental: GNbAC1

Monthly IV repeated dose

Drug: GNbAC1

Monthly IV repeated dose

Placebo Comparator: Placebo

Monthly IV repeated dose

Drug: Placebo

Monthly IV repeated dose

Outcome Measures

Primary Outcome Measures

Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE) [Week 1 to 24/48]
Serious Adverse Events (SAE) and Adverse Events (AE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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