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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
argenx
Study ID
NCT06558279
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Myasthenia Gravis, Ocular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod PH20 SC — COMBINATION_PRODUCT
    Subcutaneous efgartigimod PH20 SC given by prefilled syringe
  • Placebo PH20 SC — OTHER
    Subcutaneous placebo PH20 SC given by prefilled syringe

Study Details

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.

Key Dates

Start date
Sep 18, 2024
Status verified
Dec 2025
Primary completion
Jan 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
141 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod PH20 SC in part A+B
    Participants receiving efgartigimod PH20 SC during part A and part B
  • 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

Primary Outcome Measure

MGII (PRO) ocular score change from baseline to day 29 in part A [ Time Frame: Up to 29 days ]

Locations (20)

FacilityCityStateZIPSite coordinators
HonorHealth Neurology - Bob Bové Neuroscience InstituteScottsdaleArizona85251-
Loma Linda University HealthLoma LindaCalifornia92354-
USC Roski Eye Institute - Los AngelesLos AngelesCalifornia90033-
University of California San FranciscoSan FranciscoCalifornia94143-
Neurology Offices of South FloridaBoca RatonFlorida33428-4221-
SFM Clinical Research, LLCBoca RatonFlorida33487-2768-
Neurology Associates PAMaitlandFlorida32751-
University of South FloridaTampaFlorida33620-
Northwestern Memorial HospitalChicagoIllinois60611-
University of California IrvineColumbiaMaryland21044-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Duke Neurological Disorders ClinicDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Martha Morehouse Medical plazaColumbusOhio43221-
Penn Medicine University CityPhiladelphiaPennsylvania19104-
National Neuromuscular Research InstituteAustinTexas78759-8402-
Houston Methodist Neurological InstituteHoustonTexas77030-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Neurology - Bob Bové Neuroscience Institute· Scottsdale, AZLoma Linda University Health· Loma Linda, CAUSC Roski Eye Institute - Los Angeles· Los Angeles, CAUniversity of California San Francisco· San Francisco, CANeurology Offices of South Florida· Boca Raton, FLSFM Clinical Research, LLC· Boca Raton, FL

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