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Based on R&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.
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| Name | Class |
|---|---|
| Les Laboratoires Servier | UNKNOWN |
| Worldwide Clinical Trials | OTHER |
| Institut de Recherches Internationales Servier | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 GNbAC1 | Experimental | Monthly IV |
|
| Dose 2 GNbAC1 | Experimental | Monthly IV |
|
| Dose 3 GNbAC1 | Experimental | Monthly IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNbAC1 Monoclonal Antibody | Drug | Monthly IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital | Sofia | Bulgaria | ||||
| Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34240656 | Derived | Hartung HP, Derfuss T, Cree BA, Sormani MP, Selmaj K, Stutters J, Prados F, MacManus D, Schneble HM, Lambert E, Porchet H, Glanzman R, Warne D, Curtin F, Kornmann G, Buffet B, Kremer D, Kury P, Leppert D, Ruckle T, Barkhof F. Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Mult Scler. 2022 Mar;28(3):429-440. doi: 10.1177/13524585211024997. Epub 2021 Jul 9. |
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| 96 Weeks |
| Long term efficacy of GNbAC1 in terms of disease progression | 96 Weeks |
| Zagreb |
| Croatia |
| Hospital | Jihlava | Czechia |
| Hospital | Tallinn | Estonia |
| Hospital | Berlin | Germany |
| Hospital | Budapest | Hungary |
| Hospital | Rome | Italy |
| Hospital | Warsaw | Poland |
| Hospital | Moscow | Russia |
| Hospital | Belgrade | Serbia |
| Hospital | Barcelona | Spain |
| Hospital | Kharkiv | Ukraine |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C581064 | temelimab |
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