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

G

GeNeuro

Status and phase

Terminated
Phase 2

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: GNbAC1 Monoclonal Antibody

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03239860
GNC-004

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

220 participants in 3 patient groups

Dose 1 GNbAC1
Experimental group
Description:
Monthly IV
Treatment:
Drug: GNbAC1 Monoclonal Antibody
Dose 2 GNbAC1
Experimental group
Description:
Monthly IV
Treatment:
Drug: GNbAC1 Monoclonal Antibody
Dose 3 GNbAC1
Experimental group
Description:
Monthly IV
Treatment:
Drug: GNbAC1 Monoclonal Antibody

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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