Status:
TERMINATED
Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis
Lead Sponsor:
GeNeuro SA
Collaborating Sponsors:
Les Laboratoires Servier
Worldwide Clinical Trials
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 multi...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
June 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2018
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03239860
Start Date
June 6 2017
End Date
November 14 2018
Last Update
October 20 2020
Active Locations (12)
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1
Hospital
Sofia, Bulgaria
2
Hospital
Zagreb, Croatia
3
Hospital
Jihlava, Czechia
4
Hospital
Tallinn, Estonia