Randomised, Double-Blind, Placebo-Controlled Study to Investigate GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GeNeuro Australia PTY Ltd
- Enrollment
- 64
- Locations
- 13
- Primary Endpoint
- Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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]).
Exclusion Criteria
- •Subjects with type 2 diabetes;
- •Pregnant and nursing women.
Arms & Interventions
GNbAC1
Monthly IV repeated dose
Intervention: GNbAC1 (Drug)
Placebo
Monthly IV repeated dose
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported