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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03179423

Acronym

RAINBOW-T1D

Enrollment

Registered

2017-06-07

Start date

2017-06-14

Completion date

2019-05-07

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGGNbAC1

Monthly IV repeated dose

DRUGPlacebo

Monthly IV repeated dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of GNbAC1 in patients with recent onset type 1 diabetes: Serious Adverse Events (SAE) and Adverse Events (AE)	Week 1 to 24/48	Serious Adverse Events (SAE) and Adverse Events (AE)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026