NCT02965573

A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.

Detailed description

Myasthenia Gravis (MG) is an autoimmune disorder characterized in most cases by T cell and antibody responses to neuromuscular junction proteins such as skeletal muscle nicotinic acetylcholine receptor (AChR). Antibodies against epitopes of the AChR of the neuromuscular junction cause failure of neuromuscular transmission, resulting in the characteristic fatigue and weakness associated with this severe disorder. The study will evaluate an innovative candidate in MG.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
BIOLOGICAL	ARGX-113
DRUG	Placebo

Timeline

• Start date: 2016-12-30
• Primary completion: 2017-10-20
• Completion: 2017-10-20
• First posted: 2016-11-17
• Last updated: 2024-08-28
• Results posted: 2021-01-08

Locations

19 sites across 8 countries: United States, Belgium, Canada, Italy, Netherlands, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study