Recruiting

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

Sponsor:

argenx

Code:

NCT06909214

Conditions

New Onset Generalized Myasthenia Gravis (gMG)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Efgartigimod PH20 SC

Study Details

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.

Conditions

New Onset Generalized Myasthenia Gravis (gMG)

Study ID

NCT06909214

Start date

Apr 17, 2025

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Efgartigimod PH20 SC

Participants receiving efgartigimod PH20 SC

Interventions

Efgartigimod PH20 SC

Subcutaneous injection of efgartigimod PH20 SC

Primary outcome measure

Proportion of participants who achieve MSE of MG at any time within the first 16 weeks of treatment with efgartigimod PH20 SC [ Time Frame: up to 16 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information