ANGEL-MS
What it found
The trial ended early for another reason (see below).
Reason given: Based on R\&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.
What was tested
Treatment tested
- GNbAC1 Monoclonal Antibody
- Temelimab
Syncytin-1 inhibitor
What it measured
Main measures
Long term safety of GNbAC1
96 Weeks
Immune responseSafetyThe following parameters will be evaluated to assess the long term safety of GNbAC1:
Safety
Other measures (5)
Long term efficacy of GNbAC1 in terms of MRI outcomes
96 Weeks
MRI lesionsLong term efficacy of GNbAC1 in terms of relapse rate
96 Weeks
RelapsesLong term efficacy of GNbAC1 in terms of disability
96 Weeks
Long term efficacy of GNbAC1 in terms of disease progression
96 Weeks
The following parameters will be evaluated to assess the long term efficacy of GNbAC1:
Who could take part
Relapsing MS · 18 to 55
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study.Mult Scler · 2022
No safety issues emerged.
Read by software from the paper's abstract
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History
Started
Jun 2017
Main results due
Nov 2018
Finished
Nov 2018
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