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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03239860
• Date of registration: 12/07/2017
• Prospective Registration: No
• Primary sponsor: GeNeuro SA
• Public title: Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis ANGEL-MS
• Scientific title: A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis
• Date of first enrolment: June 6, 2017
• Target sample size: 220
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03239860
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

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

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: GNbAC1 Monoclonal Antibody

Primary Outcome(s)

Long term safety of GNbAC1 [Time Frame: 96 Weeks]

Secondary Outcome(s)

Long term efficacy of GNbAC1 in terms of disability [Time Frame: 96 Weeks]

Long term efficacy of GNbAC1 in terms of disease progression [Time Frame: 96 Weeks]

Long term efficacy of GNbAC1 in terms of relapse rate [Time Frame: 96 Weeks]

Long term efficacy of GNbAC1 in terms of MRI outcomes [Time Frame: 96 Weeks]

Secondary ID(s)

GNC-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Les Laboratoires Servier

Institut de Recherches Internationales Servier

Worldwide Clinical Trials