Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS

An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02782858

Acronym

CHANGE-MS

Enrollment

270

Registered

2016-05-25

Start date

2016-04-30

Completion date

2017-12-31

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

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Multiple Sclerosis Relapsing-Remitting, GNbAC1, MRI, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, MS, RRMS, HERV-W, Temelimab

Brief summary

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis (MS). This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.

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)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * For male or female with reproductive potential, use of reliable means of contraception; * RRMS according to the 2010 revised McDonald criteria; * Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months; * EDSS score \< 6.0. Main

Exclusion criteria

* Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening; * Pregnant and nursing women.

Design outcomes

Primary

Measure	Time frame
Cumulative number of Gd-enhancing T1 lesions in brain MRI	Week 12 to 24

Countries

Bulgaria, Croatia, Czechia, Estonia, Germany, Hungary, Italy, Poland, Russia, Serbia, Spain, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026