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Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

NCT03239860 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

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.

The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

GNbAC1 Monoclonal Antibody

Monthly IV

Sponsors & Collaborators

  • Les Laboratoires Servier

    collaborator UNKNOWN

  • Worldwide Clinical Trials

    collaborator OTHER

  • Institut de Recherches Internationales Servier

    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
2017-06-06
Primary Completion
2018-11-14
Completion
2018-11-14

Countries

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

Study Locations

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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 NCT03239860 on ClinicalTrials.gov