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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— ANGEL-MS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03239860
• Other study ID #: GNC-004
• Status: Terminated
• Phase: Phase 2
• Start date: June 6, 2017
• Est. completion date: November 14, 2018

Study information

• Verified date: December 2018
• Source: GeNeuro SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: November 14, 2018
• Est. primary completion date: November 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• GNbAC1 Monoclonal Antibody
Monthly IV

Locations

Country	Name	City	State
Bulgaria	Hospital	Sofia
Croatia	Hospital	Zagreb
Czechia	Hospital	Jihlava
Estonia	Hospital	Tallinn
Germany	Hospital	Berlin
Hungary	Hospital	Budapest
Italy	Hospital	Rome
Poland	Hospital	Warsaw
Russian Federation	Hospital	Moscow
Serbia	Hospital	Belgrade
Spain	Hospital	Barcelona
Ukraine	Hospital	Kharkiv

Sponsors (4)

Lead Sponsor	Collaborator
GeNeuro SA	Institut de Recherches Internationales Servier, Les Laboratoires Servier, Worldwide Clinical Trials

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term safety of GNbAC1	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	96 Weeks
Secondary	Long term efficacy of GNbAC1 in terms of MRI outcomes		96 Weeks
Secondary	Long term efficacy of GNbAC1 in terms of relapse rate		96 Weeks
Secondary	Long term efficacy of GNbAC1 in terms of disability		96 Weeks
Secondary	Long term efficacy of GNbAC1 in terms of disease progression		96 Weeks