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NCT06909214 | RECRUITING | New Onset Generalized Myasthenia Gravis (gMG)

A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Sponsor:

argenx

Brief Summary:

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.

Condition or disease

New Onset Generalized Myasthenia Gravis (gMG)

Intervention/treatment

Efgartigimod PH20 SC

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis
Actual Study Start Date : 2025-04-17
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Is at least 18 years when signing the ICF
  • * Has been diagnosed with gMG of MGFA class II, III, or IV
  • * Is seropositive for AChR-Ab
  • * Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG
  • * Had onset of generalized MG signs and/or symptoms within 12 months before screening; candidates who also had onset of ocular MG signs and/or symptoms within 24 months before screening may be enrolled in the study
  • * Has an MG-ADL score ≥5
Exclusion Criteria
  • * gMG diagnosis of MGFA class I or V
  • * Underwent a thymectomy prior to screening, except thymectomy for treatment of nonmalignant thymoma prior to the gMG diagnosis
  • * Prior or current use of any of any systemic corticosteroid therapy or nonsteroidal immunosuppressive therapy for the treatment of gMG
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

Location Details

NCT06909214

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Samir Macwan, M.D., Inc. (S corporation)

Rancho Mirage, California, United States, 92270

RECRUITING

United States, Florida

EZR Research

Boca Raton, Florida, United States, 33486

RECRUITING

United States, Florida

Medsol Clinical Research Center Inc

Port Charlotte, Florida, United States, 33952

RECRUITING

United States, Tennessee

Erlanger Neuroscience Institute

Chattanooga, Tennessee, United States, 37403