Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03239860

Acronym

ANGEL-MS

Enrollment

220

Registered

2017-08-04

Start date

2017-06-06

Completion date

2018-11-14

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGGNbAC1 Monoclonal Antibody

Monthly IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Long term safety of GNbAC1	96 Weeks	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

Secondary

Measure	Time frame
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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026