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

This study is currently recruiting participants.
Verified September 2017 by GeNeuro Australia PTY Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT03179423
First Posted: June 7, 2017
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Southern Star Research Pty Ltd.
Information provided by (Responsible Party):
GeNeuro Australia PTY Ltd
  Purpose

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 for 20 weeks in T1D subjects. 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 Intervention Phase
Diabetes Mellitus Type 1 Drug: GNbAC1 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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

Resource links provided by NLM:


Further study details as provided by GeNeuro Australia PTY Ltd:

Primary Outcome Measures:
  • Safety and tolerability of six consecutive 4-weekly doses of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE) [ Time Frame: Week 1 to 24 ]
    Serious Adverse Events (SAE) and Adverse Events (AE)


Estimated Enrollment: 60
Actual Study Start Date: June 14, 2017
Estimated Study Completion Date: September 1, 2018
Estimated Primary Completion Date: September 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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


Contacts
Contact: Sam Oates 61 2 9011 6266 soates@southernstarresearch.com

Locations
Australia, New South Wales
Macquarie University Hospital Recruiting
Macquarie University, New South Wales, Australia
Contact: Champion, MD         
AIM Centre Recruiting
Merewether, New South Wales, Australia
Contact: Morbey , MD         
Northern Sydney Local Health District - Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia
Contact: Duke , MD         
Australia, Queensland
Ipswich Research Centre Recruiting
Ipswich, Queensland, Australia
Contact: Nathow , MD         
Mater Misericordiae Ltd and Mater Medical Research Institute Limited Recruiting
South Brisbane, Queensland, Australia
Contact: O'Sullivan , MD         
Gold Coast Hospital and Health Service Recruiting
Southport, Queensland, Australia
Contact: Davoren , MD         
Australia, South Australia
Southern Adelaide Local Health Network - Repatriation General Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Stranks , MD         
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital Recruiting
Elizabeth Vale, South Australia, Australia
Contact: Vora , MD         
Australia, Victoria
Eastern Health Recruiting
Box Hill, Victoria, Australia
Contact: Gilfillan , MD         
St Vincent's Hospital (Melbourne) Limited Recruiting
Fitzroy, Victoria, Australia
Contact: O'Neal , MD         
Barwon Health - University of Geelong Recruiting
Geelong, Victoria, Australia
Contact: Roberts , MD         
Heidelberg Repatriation Hospital Recruiting
Heidelberg, Victoria, Australia
Contact: Ekinci , MD         
Australia, Western Australia
Keogh Institute of Medical Research Not yet recruiting
Nedlands, Western Australia, Australia
Contact: Stuckey, MD         
Sponsors and Collaborators
GeNeuro Australia PTY Ltd
Southern Star Research Pty Ltd.
  More Information

Responsible Party: GeNeuro Australia PTY Ltd
ClinicalTrials.gov Identifier: NCT03179423     History of Changes
Other Study ID Numbers: GNC-301
First Submitted: June 1, 2017
First Posted: June 7, 2017
Last Update Posted: September 20, 2017
Last Verified: September 2017
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