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

Primary Purpose

Diabetes Mellitus Type 1

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
GNbAC1
Placebo
Sponsored by
GeNeuro Australia PTY Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring Diabetes Mellitus, Type 1, T1D, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, Human Endogenous Retrovirus Type W (HERV-W), GNbAC1, Temelimab

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Macquarie University Hospital
  • AIM Centre
  • Northern Sydney Local Health District - Royal North Shore Hospital
  • Ipswich Research Centre
  • Mater Misericordiae Ltd and Mater Medical Research Institute Limited
  • Gold Coast Hospital and Health Service
  • Southern Adelaide Local Health Network - Repatriation General Hospital
  • Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
  • Eastern Health
  • St Vincent's Hospital (Melbourne) Limited
  • Barwon Health - University of Geelong
  • Heidelberg Repatriation Hospital
  • Keogh Institute of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GNbAC1

Placebo

Arm Description

Monthly IV repeated dose

Monthly IV repeated dose

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 1, 2017
Last Updated
October 19, 2020
Sponsor
GeNeuro Australia PTY Ltd
Collaborators
Southern Star Research Pty Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03179423
Brief Title
Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Acronym
RAINBOW-T1D
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeNeuro Australia PTY Ltd
Collaborators
Southern Star Research Pty Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GNbAC1
Arm Type
Experimental
Arm Description
Monthly IV repeated dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Monthly IV repeated dose
Intervention Type
Drug
Intervention Name(s)
GNbAC1
Intervention Description
Monthly IV repeated dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Monthly IV repeated dose
Primary Outcome Measure Information:
Title
Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE)
Description
Serious Adverse Events (SAE) and Adverse Events (AE)
Time Frame
Week 1 to 24/48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Macquarie University Hospital
City
Macquarie University
State/Province
New South Wales
Country
Australia
Facility Name
AIM Centre
City
Merewether
State/Province
New South Wales
Country
Australia
Facility Name
Northern Sydney Local Health District - Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Ipswich Research Centre
City
Ipswich
State/Province
Queensland
Country
Australia
Facility Name
Mater Misericordiae Ltd and Mater Medical Research Institute Limited
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Gold Coast Hospital and Health Service
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Southern Adelaide Local Health Network - Repatriation General Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
Country
Australia
Facility Name
Eastern Health
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
St Vincent's Hospital (Melbourne) Limited
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Barwon Health - University of Geelong
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Heidelberg Repatriation Hospital
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Keogh Institute of Medical Research
City
Nedlands
State/Province
Western Australia
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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