NCT02782858

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Geographic Reach
11 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 20, 2020

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

May 23, 2016

Last Update Submit

October 19, 2020

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple SclerosisMultiple Sclerosis Relapsing-RemittingGNbAC1MRIMonoclonal antibodyMultiple Sclerosis associated retrovirus MSRVMSRRMSHERV-WTemelimab

Outcome Measures

Primary Outcomes (1)

  • Cumulative number of Gd-enhancing T1 lesions in brain MRI

    Week 12 to 24

Study Arms (4)

Dose 1 GNbAC1

EXPERIMENTAL

Monthly IV repeated dose

Drug: GNbAC1

Dose 2 GNbAC1

EXPERIMENTAL

Monthly IV repeated dose

Drug: GNbAC1

Dose 3 GNbAC1

EXPERIMENTAL

Monthly IV repeated dose

Drug: GNbAC1

Placebo

PLACEBO COMPARATOR

Monthly IV repeated dose

Drug: Placebo

Interventions

GNbAC1DRUG

Monthly IV repeated dose

Dose 1 GNbAC1Dose 2 GNbAC1Dose 3 GNbAC1
PlaceboDRUG

Monthly IV repeated dose

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;
  • Pregnant and nursing women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Sofia, Bulgaria

Location

Unknown Facility

Zagreb, Croatia

Location

Unknown Facility

Jihlava, Czechia

Location

Unknown Facility

Tallinn, Estonia

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Belgrade, Serbia

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Kharkiv, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 34240656DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

temelimab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

May 25, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

October 20, 2020

Record last verified: 2018-01

Locations

SE(1)BU(1)ES(1)DE(1)CZ(1)HU(1)CR(1)IT(1)RU(1)UA(1)PL(1)