Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years

Study Overview
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Brief Summary
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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.

Official Title
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Randomised, Double-Blind, Placebo-Controlled Study to Investigate GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years

Conditions
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Diabetes Mellitus Type 1

Intervention / Treatment
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* Drug: GNbAC1
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GNbAC1<br>Monthly IV repeated dose | Drug: GNbAC1<br>* Monthly IV repeated dose<br>|
| Placebo Comparator: Placebo<br>Monthly IV repeated dose | Drug: Placebo<br>* Monthly IV repeated dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Week 1 to 24/48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis associated retrovirus MSRV, Temelimab, Diabetes Mellitus, Type 1, T1D, Monoclonal antibody, Human Endogenous Retrovirus Type W (HERV-W), GNbAC1