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
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
A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.
Inclusion Criteria:
Other, more specific inclusion criteria are defined in the protocol
Exclusion Criteria:
Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing.
MGFA Class I and V patients.
Patients with worsening muscle weakness secondary to concurrent infections or medications.
Patients with known seropositivity or who test positive for an active viral infection at Screening with:
Other, more specific exclusion criteria are further defined in the protocol.
Ostrava-Poruba, 70852, Czechia
Minato-Ku, Tokyo 108-8329, Japan
Shinjuku-Ku, Tokyo 160-0023, Japan