Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years (RAINBOW-T1D)

GeNeuro

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 1

Treatments: Drug: Placebo; Drug: GNbAC1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03179423

GNC-301

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

GNbAC1

Experimental group

Description:

Monthly IV repeated dose

Treatment:

Drug: GNbAC1

Placebo

Placebo Comparator group

Description:

Monthly IV repeated dose

Treatment:

Drug: Placebo