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

NCT02782858 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2020-10-20

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

GNbAC1

Monthly IV repeated dose

DRUG

Placebo

Monthly IV repeated dose

Sponsors & Collaborators

  • Les Laboratoires Servier (LLS)

    collaborator UNKNOWN

  • Institut de Recherches Internationales Servier

    collaborator OTHER

  • Worldwide Clinical Trials

    collaborator OTHER

  • GeNeuro SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-08-31
Completion
2017-12-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02782858 on ClinicalTrials.gov