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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03179423




Registration number
NCT03179423
Ethics application status
Date submitted
1/06/2017
Date registered
7/06/2017
Date last updated
22/05/2019

Titles & IDs
Public title
Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Scientific title
Randomised, Double-Blind, Placebo-Controlled Study to Investigate GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Secondary ID [1] 0 0
GNC-301
Universal Trial Number (UTN)
Trial acronym
RAINBOW-T1D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GNbAC1
Treatment: Drugs - Placebo

Experimental: GNbAC1 - Monthly IV repeated dose

Placebo Comparator: Placebo - Monthly IV repeated dose


Treatment: Drugs: GNbAC1
Monthly IV repeated dose

Treatment: Drugs: Placebo
Monthly IV repeated dose

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Week 1 to 24/48

Eligibility
Key inclusion criteria
Main

- 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects with type 2 diabetes;

- Pregnant and nursing women.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [2] 0 0
AIM Centre - Merewether
Recruitment hospital [3] 0 0
Northern Sydney Local Health District - Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Ipswich Research Centre - Ipswich
Recruitment hospital [5] 0 0
Mater Misericordiae Ltd and Mater Medical Research Institute Limited - South Brisbane
Recruitment hospital [6] 0 0
Gold Coast Hospital and Health Service - Southport
Recruitment hospital [7] 0 0
Southern Adelaide Local Health Network - Repatriation General Hospital - Adelaide
Recruitment hospital [8] 0 0
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [9] 0 0
Eastern Health - Box Hill
Recruitment hospital [10] 0 0
St Vincent's Hospital (Melbourne) Limited - Fitzroy
Recruitment hospital [11] 0 0
Barwon Health - University of Geelong - Geelong
Recruitment hospital [12] 0 0
Heidelberg Repatriation Hospital - Heidelberg
Recruitment hospital [13] 0 0
Keogh Institute of Medical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Macquarie University
Recruitment postcode(s) [2] 0 0
- Merewether
Recruitment postcode(s) [3] 0 0
- St Leonards
Recruitment postcode(s) [4] 0 0
- Ipswich
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- Southport
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
- Elizabeth Vale
Recruitment postcode(s) [9] 0 0
- Box Hill
Recruitment postcode(s) [10] 0 0
- Fitzroy
Recruitment postcode(s) [11] 0 0
- Geelong
Recruitment postcode(s) [12] 0 0
- Heidelberg
Recruitment postcode(s) [13] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GeNeuro Australia PTY Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Southern Star Research Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03179423
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications