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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Is at least 18 years of age and the local legal age of consent for clinical studies - 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" - Is MGFA Class I (any ocular muscle weakness) - 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

Exclusion Criteria

  • Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Efgartigimod PH20 SC in part A+B 		Participants receiving efgartigimod PH20 SC during part A and part B
  • Combination Product: Efgartigimod PH20 SC
    Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Experimental
Placebo PH20 SC in Part A + Efgartigimod PH20 SC in Part B 		Participants receiving placebo PH20 SC in Part A and Efgartigimod PH20 SC in Part B
  • Combination Product: Efgartigimod PH20 SC
    Subcutaneous efgartigimod PH20 SC given by prefilled syringe
  • Other: Placebo PH20 SC
    Subcutaneous placebo PH20 SC given by prefilled syringe

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Amanda Guidon, MD
857-350-4834
clinicaltrials@argenx.com

More Details

Status
Recruiting
Sponsor
argenx

Study Contact

Sabine Coppieters, MD
857-350-4834
clinicaltrials@argenx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.