ACTIVE_NOT_RECRUITING

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.

Official Title

A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis

Quick Facts

Study Start:2024-09-18
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06558279

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is at least 18 years of age and the local legal age of consent for clinical studies
  2. * Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy"
  3. * Is MGFA Class I (any ocular muscle weakness)
  4. * Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2
  1. * Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia
  2. * Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk

Contacts and Locations

Study Locations (Sites)

HonorHealth Neurology - Bob Bové Neuroscience Institute
Scottsdale, Arizona, 85251
United States
Loma Linda University Health
Loma Linda, California, 92354
United States
USC Roski Eye Institute - Los Angeles
Los Angeles, California, 90033
United States
University of California San Francisco
San Francisco, California, 94143
United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428-4221
United States
SFM Clinical Research, LLC
Boca Raton, Florida, 33487-2768
United States
Neurology Associates PA
Maitland, Florida, 32751
United States
University of South Florida
Tampa, Florida, 33620
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University of California Irvine
Columbia, Maryland, 21044
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Duke Neurological Disorders Clinic
Durham, North Carolina, 27710
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Martha Morehouse Medical plaza
Columbus, Ohio, 43221
United States
Penn Medicine University City
Philadelphia, Pennsylvania, 19104
United States
National Neuromuscular Research Institute
Austin, Texas, 78759-8402
United States
Houston Methodist Neurological Institute
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: argenx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-09-18
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Myasthenia Gravis
  • Ocular myasthenia

Additional Relevant MeSH Terms

  • Myasthenia Gravis, Ocular