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

NCT ID: NCT02782858

Last Updated: 2020-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1 GNbAC1

Monthly IV repeated dose

Group Type EXPERIMENTAL

GNbAC1

Intervention Type DRUG

Monthly IV repeated dose

Dose 2 GNbAC1

Monthly IV repeated dose

Group Type EXPERIMENTAL

GNbAC1

Intervention Type DRUG

Monthly IV repeated dose

Dose 3 GNbAC1

Monthly IV repeated dose

Group Type EXPERIMENTAL

GNbAC1

Intervention Type DRUG

Monthly IV repeated dose

Placebo

Monthly IV repeated dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Monthly IV repeated dose

Interventions

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GNbAC1

Monthly IV repeated dose

Intervention Type DRUG

Placebo

Monthly IV repeated dose

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion Criteria

* Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;
* Pregnant and nursing women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Les Laboratoires Servier (LLS)

UNKNOWN

Sponsor Role collaborator

Institut de Recherches Internationales Servier

OTHER

Sponsor Role collaborator

Worldwide Clinical Trials

OTHER

Sponsor Role collaborator

GeNeuro SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sofia, , Bulgaria

Site Status

Zagreb, , Croatia

Site Status

Jihlava, , Czechia

Site Status

Tallinn, , Estonia

Site Status

Berlin, , Germany

Site Status

Budapest, , Hungary

Site Status

Roma, , Italy

Site Status

Warsaw, , Poland

Site Status

Moscow, , Russia

Site Status

Belgrade, , Serbia

Site Status

Barcelona, , Spain

Site Status

Kharkiv, , Ukraine

Site Status

Countries

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

References

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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.

Reference Type DERIVED
PMID: 34240656 (View on PubMed)

Other Identifiers

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2015-004059-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GNC-003

Identifier Type: -

Identifier Source: org_study_id

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