ARDA+
Research type
Research Study
Full title
A Long-Term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerabillity, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy
IRAS ID
1006042
Contact name
Sabine Coppieters
Contact email
Sponsor organisation
argenx BV
Eudract number
2021-004998-32
Clinicaltrials.gov Identifier
Research summary
This long-term extension trial serves to evaluate the long-term safety and efficacy of ARGX-117 in adults with multifocal motor neuropathy (MMN). \nMMN is a rare neuropathy characterised by progressive asymmetric weakness and atrophy without sensory abnormalities. \nPatients with MMN initially respond to the standard of care (SoC), intravenous immunoglobulin (IVIg); however, the disease will continue to progress despite treatment. There is an unmet medical need for an efficacious treatment option with a more favorable safety and tolerability \nprofile and a shorter duration of administration than the current SoC.\nARGX-117, a therapeutic complement-inhibiting antibody that targets complement factor (C2), is being developed to reduce tissue inflammation and attenuate the adaptive immune response by blocking both the lectin and classical complement pathways. \nParticipants in this long-term extension trial will roll over from the antecedent trial, ARGX-117-2002, which evaluated the safety and tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of 2 dose regimens of ARGX-117 administered \nintravenously (IV) in adult participants with MMN previously stabilised with IVIg.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0356
Date of REC Opinion
1 Mar 2023
REC opinion
Further Information Favourable Opinion