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

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ClinicalTrials.gov Identifier: NCT03179423
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Southern Star Research Pty Ltd.
Information provided by (Responsible Party):
GeNeuro Australia PTY Ltd

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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.
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 : June 14, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE) [ Time Frame: Week 1 to 24/48 ]
    Serious Adverse Events (SAE) and Adverse Events (AE)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179423


Locations
Australia, New South Wales
Macquarie University Hospital
Macquarie University, New South Wales, Australia
AIM Centre
Merewether, New South Wales, Australia
Northern Sydney Local Health District - Royal North Shore Hospital
St Leonards, New South Wales, Australia
Australia, Queensland
Ipswich Research Centre
Ipswich, Queensland, Australia
Mater Misericordiae Ltd and Mater Medical Research Institute Limited
South Brisbane, Queensland, Australia
Gold Coast Hospital and Health Service
Southport, Queensland, Australia
Australia, South Australia
Southern Adelaide Local Health Network - Repatriation General Hospital
Adelaide, South Australia, Australia
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Australia, Victoria
Eastern Health
Box Hill, Victoria, Australia
St Vincent's Hospital (Melbourne) Limited
Fitzroy, Victoria, Australia
Barwon Health - University of Geelong
Geelong, Victoria, Australia
Heidelberg Repatriation Hospital
Heidelberg, Victoria, Australia
Australia, Western Australia
Keogh Institute of Medical Research
Nedlands, Western Australia, Australia
Sponsors and Collaborators
GeNeuro Australia PTY Ltd
Southern Star Research Pty Ltd.
More Information
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Responsible Party: GeNeuro Australia PTY Ltd
ClinicalTrials.gov Identifier: NCT03179423     History of Changes
Other Study ID Numbers: GNC-301
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GeNeuro Australia PTY Ltd:
Diabetes Mellitus, Type 1
T1D
Monoclonal antibody
 Multiple Sclerosis associated retrovirus MSRV
Human Endogenous Retrovirus Type W (HERV-W)
GNbAC1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases