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

Phase 4RecruitingNCT06909214

argenx30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

New Onset Generalized Myasthenia Gravis (gMG)

Interventions

Efgartigimod PH20 SCBIOLOGICAL

Subcutaneous injection of efgartigimod PH20 SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)

La Jolla, California, United States

Outcomes

Primary Outcomes

Proportion of participants who achieve MSE of MG at any time within the first 16 weeks of treatment with efgartigimod PH20 SC

MSE (minimal symptom expression) is defined as an MG-ADL (Myasthenia Gravis Activities of Daily Living) total score of 0 or 1. The MG-ADL scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe).

Time frame: up to 16 weeks

Secondary Outcomes

Changes from baseline in MG-ADL total scores over time

The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe).

Time frame: up to 51 weeks

Changes from baseline in MG-QOL-15r total scores over time

The MG-QoL15r (Myasthenia Gravis Quality of Life 15-item scale revised) questionnaire is a patient-reported instrument that measures the impact of MG symptoms on Quality of Life. The score varies between 0 and 30 (with 30 the lowest quality of life).

Time frame: up to 51 weeks

Proportion of participants who are administered systemic corticosteroid therapy as background add-on therapy throughout the study

Time frame: up to 55 weeks

Incidence of adverse events, serious adverse events and adverse events leading to study drug discontinuation

Time frame: up to 55 weeks

Central Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834 clinicaltrials@argenx.com

Data from ClinicalTrials.gov

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