NCT03239860

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. The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.

Trial Health

68
Monitor

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_2

Geographic Reach
11 countries

11 active sites

Status
terminated

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

June 6, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2018

Completed
Last Updated

October 20, 2020

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

July 12, 2017

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)

  • Long term safety of GNbAC1

    The main parameters evaluated to assess the long term safety will be: AE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale

    96 Weeks

Secondary Outcomes (4)

  • Long term efficacy of GNbAC1 in terms of MRI outcomes

    96 Weeks

  • Long term efficacy of GNbAC1 in terms of relapse rate

    96 Weeks

  • Long term efficacy of GNbAC1 in terms of disability

    96 Weeks

  • Long term efficacy of GNbAC1 in terms of disease progression

    96 Weeks

Study Arms (3)

Dose 1 GNbAC1

EXPERIMENTAL

Monthly IV

Drug: GNbAC1 Monoclonal Antibody

Dose 2 GNbAC1

EXPERIMENTAL

Monthly IV

Drug: GNbAC1 Monoclonal Antibody

Dose 3 GNbAC1

EXPERIMENTAL

Monthly IV

Drug: GNbAC1 Monoclonal Antibody

Interventions

GNbAC1 Monoclonal AntibodyDRUG

Monthly IV

Dose 1 GNbAC1Dose 2 GNbAC1Dose 3 GNbAC1

Eligibility Criteria

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

You may qualify if:

  • Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study
  • Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control
  • Provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form.

You may not qualify if:

  • Patients not having completed the study GNC-003
  • Pregnancy
  • The emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient's neurological signs and symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital

Sofia, Bulgaria

Location

Hospital

Zagreb, Croatia

Location

Hospital

Jihlava, Czechia

Location

Hospital

Tallinn, Estonia

Location

Hospital

Berlin, Germany

Location

Hospital

Budapest, Hungary

Location

Hospital

Rome, Italy

Location

Hospital

Warsaw, Poland

Location

Hospital

Moscow, Russia

Location

Hospital

Belgrade, Serbia

Location

Hospital

Barcelona, Spain

Location

Hospital

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

July 12, 2017

First Posted

August 4, 2017

Study Start

June 6, 2017

Primary Completion

November 14, 2018

Study Completion

November 14, 2018

Last Updated

October 20, 2020

Record last verified: 2018-12

Locations

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