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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GNbAC1
Placebo
Sponsored by
GeNeuro SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple Sclerosis, Multiple Sclerosis Relapsing-Remitting, GNbAC1, MRI, Monoclonal antibody, Multiple Sclerosis associated retrovirus MSRV, MS, RRMS, HERV-W, Temelimab

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dose 1 GNbAC1

Dose 2 GNbAC1

Dose 3 GNbAC1

Placebo

Arm Description

Monthly IV repeated dose

Monthly IV repeated dose

Monthly IV repeated dose

Monthly IV repeated dose

Outcomes

Primary Outcome Measures

Cumulative number of Gd-enhancing T1 lesions in brain MRI

Secondary Outcome Measures

Full Information

First Posted
May 23, 2016
Last Updated
October 19, 2020
Sponsor
GeNeuro SA
Collaborators
Les Laboratoires Servier (LLS), Institut de Recherches Internationales Servier, Worldwide Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT02782858
Brief Title
Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
Acronym
CHANGE-MS
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeNeuro SA
Collaborators
Les Laboratoires Servier (LLS), Institut de Recherches Internationales Servier, Worldwide Clinical Trials

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1 GNbAC1
Arm Type
Experimental
Arm Description
Monthly IV repeated dose
Arm Title
Dose 2 GNbAC1
Arm Type
Experimental
Arm Description
Monthly IV repeated dose
Arm Title
Dose 3 GNbAC1
Arm Type
Experimental
Arm Description
Monthly IV repeated dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Monthly IV repeated dose
Intervention Type
Drug
Intervention Name(s)
GNbAC1
Intervention Description
Monthly IV repeated dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Monthly IV repeated dose
Primary Outcome Measure Information:
Title
Cumulative number of Gd-enhancing T1 lesions in brain MRI
Time Frame
Week 12 to 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Sofia
Country
Bulgaria
City
Zagreb
Country
Croatia
City
Jihlava
Country
Czechia
City
Tallinn
Country
Estonia
City
Berlin
Country
Germany
City
Budapest
Country
Hungary
City
Roma
Country
Italy
City
Warsaw
Country
Poland
City
Moscow
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Barcelona
Country
Spain
City
Kharkiv
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34240656
Citation
Hartung HP, Derfuss T, Cree BA, Sormani MP, Selmaj K, Stutters J, Prados F, MacManus D, Schneble HM, Lambert E, Porchet H, Glanzman R, Warne D, Curtin F, Kornmann G, Buffet B, Kremer D, Kury P, Leppert D, Ruckle T, Barkhof F. Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Mult Scler. 2022 Mar;28(3):429-440. doi: 10.1177/13524585211024997. Epub 2021 Jul 9.
Results Reference
derived

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

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