Clinical trial NCT03239860: Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis
Official title: A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: GeNeuro SA
Sponsor class: INDUSTRY
Collaborators: name: Les Laboratoires Servier
name: Worldwide Clinical Trials
name: Institut de Recherches Internationales Servier
First posted: 2017-08-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Main Inclusion Criteria:

* 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.

Main Exclusion Criteria:

* 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

Primary outcomes:
measure: Long term safety of GNbAC1
timeFrame: 96 Weeks
Secondary outcomes:
measure: Long term efficacy of GNbAC1 in terms of MRI outcomes
timeFrame: 96 Weeks
measure: Long term efficacy of GNbAC1 in terms of relapse rate
timeFrame: 96 Weeks
measure: Long term efficacy of GNbAC1 in terms of disability
timeFrame: 96 Weeks
measure: Long term efficacy of GNbAC1 in terms of disease progression
timeFrame: 96 Weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Hospital
city: Zagreb
country: Croatia
facility: Hospital
city: Jihlava
country: Czechia
facility: Hospital
city: Tallinn
country: Estonia
facility: Hospital
city: Berlin
country: Germany
facility: Hospital
city: Budapest
country: Hungary
facility: Hospital
city: Rome
country: Italy
facility: Hospital
city: Warsaw
country: Poland
facility: Hospital
city: Moscow
country: Russian Federation
facility: Hospital
city: Belgrade
country: Serbia
facility: Hospital
city: Barcelona
country: Spain
facility: Hospital
city: Kharkiv
country: Ukraine
facility: Hospital
Study officials:
References:
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.