NCT02565576

Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Preliminarily Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of CFZ533 in Patients With Moderate to Severe Myasthenia Gravis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics and efficacy of CFZ533 as an add-on therapy to standard of care in patients with moderate to severe myasthenia gravis (MG).

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	CFZ533

Timeline

• Start date: 2015-09-29
• Primary completion: 2017-07-31
• Completion: 2017-12-19
• First posted: 2015-10-01
• Last updated: 2021-01-05
• Results posted: 2019-07-25

Locations

15 sites across 5 countries: Canada, Denmark, Germany, Russia, Taiwan