Diabetes Mellitus Type 1Phase 2RAINBOW-T1DNCT03179423
Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
A Phase 2 study testing GNbAC1 in people with Diabetes Mellitus Type 1, run by GeNeuro Australia PTY Ltd at 13 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- GNbAC1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 13 sitesAustralia
- Study dates
- 14 Jun 2017to 7 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Australia13 sites
Southern Adelaide Local Health Network - Repatriation General Hospital
Adelaide, South Australia
Eastern Health
Box Hill, Victoria
Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
Elizabeth Vale, South Australia
St Vincent's Hospital (Melbourne) Limited
Fitzroy, Victoria
Barwon Health - University of Geelong
Geelong, Victoria
Heidelberg Repatriation Hospital
Heidelberg, Victoria
Ipswich Research Centre
Ipswich, Queensland
Macquarie University Hospital
Macquarie University, New South Wales
AIM Centre
Merewether, New South Wales
Keogh Institute of Medical Research
Nedlands, Western Australia
Mater Misericordiae Ltd and Mater Medical Research Institute Limited
South Brisbane, Queensland
Gold Coast Hospital and Health Service
Southport, Queensland
Northern Sydney Local Health District - Royal North Shore Hospital
St Leonards, New South Wales
About this study
Official title: Randomised, Double-Blind, Placebo-Controlled Study to Investigate GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
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.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- GNbAC1, Placebo
- Keywords
- Diabetes Mellitus, Type 1, T1D, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, Human Endogenous Retrovirus Type W (HERV-W), GNbAC1, Temelimab
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNbAC1Drug
Monthly IV repeated dose
PlaceboDrug
Monthly IV repeated dose
| Study group | Role | What they receive |
|---|---|---|
| GNbAC1 | Experimental | Monthly IV repeated dose Receives: Drug: GNbAC1 |
| Placebo | Placebo comparator | Monthly IV repeated dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 1 to 24/48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start14 Jun 2017
- Primary completion1 Sep 2018
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro Australia PTY Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southern Star Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179423
- Sponsor's protocol ID
- GNC-301
- Acronym
- RAINBOW-T1D
- Status last verified
- May 2019
- First submitted
- 1 Jun 2017
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-Blind, Placebo-Controlled Study to Investigate GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
- ClinicalTrials.gov ID
- NCT03179423
- Acronym / sponsor ID
- RAINBOW-T1D / GNC-301
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- Diabetes Mellitus, Type 1, T1D, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, Human Endogenous Retrovirus Type W (HERV-W), GNbAC1, Temelimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- GeNeuro Australia PTY LtdIndustry (pharma, biotech, devices)
- Collaborators
- Southern Star Research
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GNbAC1 | Experimental | Drug: GNbAC1Monthly IV repeated dose |
| Placebo | Placebo comparator | Drug: PlaceboMonthly IV repeated dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNbAC1Monthly IV repeated dose | Drug | GNbAC1 |
| PlaceboMonthly IV repeated dose | Drug | Placebo |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GNbAC1 in people with Diabetes Mellitus Type 1, run by GeNeuro Australia PTY Ltd at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.