A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness
Phase of Trial: Phase III
Latest Information Update: 27 Dec 2018
At a glance
- Drugs Efgartigimod (Primary)
- Indications Myasthenia gravis
- Focus Registrational; Therapeutic Use
- Acronyms ADAPT
- Sponsors argenx
- 06 Sep 2018 According to an Argenx media release, first patient has been dosed in this trial.
- 06 Sep 2018 Status changed from planning to recruiting, as reported in the Argenx media release.
- 29 Aug 2018 According to an Argenx media release, company announced it has received feedback from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan on the design of a Phase 3 trial and regulatory pathway towards potential marketing authorization of efgartigimod (ARGX-113) in patients with generalized myasthenia gravis (gMG).Based on feedback from the PMDA, argenx expects the data from trial, if positive, will serve as the basis to submit for marketing marketing authorization in Japan.