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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782858
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : October 20, 2020
Sponsor:
Collaborators:
Les Laboratoires Servier (LLS)
Institut de Recherches Internationales Servier
Worldwide Clinical Trials
Information provided by (Responsible Party):
GeNeuro SA

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: GNbAC1 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose 1 GNbAC1
Monthly IV repeated dose
 Drug: GNbAC1
Monthly IV repeated dose
Experimental: Dose 2 GNbAC1
Monthly IV repeated dose
 Drug: GNbAC1
Monthly IV repeated dose
Experimental: Dose 3 GNbAC1
Monthly IV repeated dose
 Drug: GNbAC1
Monthly IV repeated dose
Placebo Comparator: Placebo
Monthly IV repeated dose
 Drug: Placebo
Monthly IV repeated dose


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative number of Gd-enhancing T1 lesions in brain MRI [ Time Frame: Week 12 to 24 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782858


Locations
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Bulgaria
Sofia, Bulgaria
Croatia
Zagreb, Croatia
Czechia
Jihlava, Czechia
Estonia
Tallinn, Estonia
Germany
Berlin, Germany
Hungary
Budapest, Hungary
Italy
Roma, Italy
Poland
Warsaw, Poland
Russian Federation
Moscow, Russian Federation
Serbia
Belgrade, Serbia
Spain
Barcelona, Spain
Ukraine
Kharkiv, Ukraine
Sponsors and Collaborators
GeNeuro SA
Les Laboratoires Servier (LLS)
Institut de Recherches Internationales Servier
Worldwide Clinical Trials
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GeNeuro SA
ClinicalTrials.gov Identifier: NCT02782858    
Other Study ID Numbers: GNC-003
2015-004059-29 ( EudraCT Number )
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: January 2018
Keywords provided by GeNeuro SA:
Multiple Sclerosis
Multiple Sclerosis Relapsing-Remitting
GNbAC1
MRI
Monoclonal antibody
 Multiple Sclerosis associated retrovirus MSRV
MS
RRMS
HERV-W
Temelimab
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases