This study is in progress, not accepting new patients

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

a study on Myasthenia Gravis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Perry B. Shieh, MD, PhD
Headshot of Perry B. Shieh
Perry B. Shieh

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

Keywords

Generalized Myasthenia Gravis, ALXN1720, anti-acetylcholine receptor antibody-positive, acetylcholine receptor, AChR, myasthenia gravis, MG, gMG, complement component 5, C5, VHH antibody, Muscle Weakness

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
  • Positive serological test for autoantibodies against AChR

You CAN'T join if...

  • History of thymectomy, or any other thymic surgery within 12 months prior to Screening
  • Untreated thymic malignancy, carcinoma, or thymoma
  • History of Neisseria meningitidis infection
  • Pregnancy, breastfeeding, or intention to conceive during the course of the study

Locations

  • Research Site
    Orange California 92868 United States
  • Research Site
    Las Vegas Nevada 89117 United States

Lead Scientist at UCLA

  • Perry B. Shieh, MD, PhD
    HS Clinical Professor, Neurology, Medicine. Authored (or co-authored) 90 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals, Inc.
Links
Sign up for this study
ID
NCT05556096
Phase
Phase 3 Myasthenia Gravis Research Study
Study Type
Interventional
Participants
About 260 people participating
Last Updated
Contact us about this trial