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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

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date October 20, 2020
Study Start Date  ICMJE April 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
Cumulative number of Gd-enhancing T1 lesions in brain MRI [ Time Frame: Week 12 to 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE
  • Drug: GNbAC1
    Monthly IV repeated dose
  • Drug: Placebo
    Monthly IV repeated dose
Study Arms  ICMJE
  • Experimental: Dose 1 GNbAC1
    Monthly IV repeated dose
    Intervention: Drug: GNbAC1
  • Experimental: Dose 2 GNbAC1
    Monthly IV repeated dose
    Intervention: Drug: GNbAC1
  • Experimental: Dose 3 GNbAC1
    Monthly IV repeated dose
    Intervention: Drug: GNbAC1
  • Placebo Comparator: Placebo
    Monthly IV repeated dose
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2018)
270
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2016)
260
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Croatia,   Czechia,   Estonia,   Germany,   Hungary,   Italy,   Poland,   Russian Federation,   Serbia,   Spain,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02782858
Other Study ID Numbers  ICMJE GNC-003
2015-004059-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GeNeuro SA
Study Sponsor  ICMJE GeNeuro SA
Collaborators  ICMJE
  • Les Laboratoires Servier (LLS)
  • Institut de Recherches Internationales Servier
  • Worldwide Clinical Trials
Investigators  ICMJE Not Provided
PRS Account GeNeuro SA
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP