ARDA
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
IRAS ID
1004307
Contact name
Sabine Coppieters
Contact email
Sponsor organisation
argenx BV
Eudract number
2021-003302-50
Clinicaltrials.gov Identifier
Research summary
This is a study for patients with multifocal motor neuropathy (MMN) that have been receiving intravenous immune globulin (IVIg). MMN is a disorder in which the immune system attacks the nervous system, causing weakness in the hands, arms, and/or legs. \nA new drug called ARGX-117’will be tested in this trial. It has already been used in both nonclinical & clinical studies, which showed that it has a favourable safety profile and may be an effective compound in diseases such as MMN. \nARGX-117 is an antibody, modified to better bind to specific proteins called “complement component 2 (C2).” It is a new compound that may be used to treat diseases that are related to the complement system (part of the immune system which plays a central role in the body’s defense against infections).\nARGX-117 or placebo will be given by intravenous (IV) infusion. \nThe purpose of this study is to assess how effective the drug called ‘ARGX-117’ is in treating patients with MMN, how safe and tolerable the new drug is. Other purposes of the study are to see how the body reacts to IV doses of ARGX-117 and the impact of ARGX-117 on the body. \nFor reliable results, a dummy drug (placebo) will be used to compare the treatment with ARGX-117.\nThe study will start with a screening period (up to 28 days and/or a maximum of 42 days). Some patients will have an ‘IVIg dependency period’ (up to 15 weeks). All patients will have an ‘IVIg monitoring period’ (up to 11 weeks), followed by a treatment period of 16 weeks. After which the patients will enter a treatment-free period of 40 weeks. The maximum duration of the study is 88 weeks.\nUnder certain conditions, the patients can choose to go to the long-term extension study ARGX-117-2003, after completing the double-blinded treatment period. In that trial, all patients will receive the study drug (ARGX-117).
REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0407
Date of REC Opinion
15 Feb 2022
REC opinion
Further Information Favourable Opinion