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 :
Completed
First Posted : June 7, 2017
Last Update Posted : October 20, 2020
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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 Type : | Interventional (Clinical Trial) |
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. |
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 |
Actual Primary Completion Date : | September 1, 2018 |
Actual Study Completion Date : | May 7, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: GNbAC1
Monthly IV repeated dose
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Drug: GNbAC1
Monthly IV repeated dose |
Placebo Comparator: Placebo
Monthly IV repeated dose
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Drug: Placebo
Monthly IV repeated dose |
- 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)

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Responsible Party: | GeNeuro Australia PTY Ltd |
ClinicalTrials.gov Identifier: | NCT03179423 |
Other Study ID Numbers: |
GNC-301 |
First Posted: | June 7, 2017 Key Record Dates |
Last Update Posted: | October 20, 2020 |
Last Verified: | May 2019 |
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 |
Diabetes Mellitus, Type 1 T1D Monoclonal antibody Multiple Sclerosis associated retrovirus MSRV |
Human Endogenous Retrovirus Type W (HERV-W) GNbAC1 Temelimab |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |