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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03179423




Registration number
NCT03179423
Ethics application status
Date submitted
1/06/2017
Date registered
7/06/2017
Date last updated
20/10/2020

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)
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
Sex
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
14/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2019
Sample size
Target
Accrual to date
Final
64
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
Commercial sector/Industry
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03179423