Efgartigimod for Myasthenia Gravis

(ADAPT-EARLY Trial)

Overseen By Sabine Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: argenx

Must be taking: AChEI

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Thymectomy, MGFA class I or V, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 51 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults recently diagnosed with generalized Myasthenia Gravis (gMG) can join this study. They should have had muscle weakness symptoms for less than a year, be positive for AChR-Ab antibodies, and either haven't been treated or only used AChEI drugs. Their MG-ADL score must be 5 or higher.

Inclusion Criteria

I have been diagnosed with a moderate to severe form of myasthenia gravis.

I have tested positive for AChR antibodies.

My daily activities are significantly affected by my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive efgartigimod PH20 SC for 51 weeks to evaluate clinical outcomes in new-onset generalized myasthenia gravis

51 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-7 weeks

Treatment Details

Interventions

• Efgartigimod PH20 SC

Trial Overview The trial is testing Efgartigimod PH20 SC's effectiveness in treating gMG over a period of 51 weeks. Participants will undergo treatment to see if it improves their condition compared to before the trial started.

Participant Groups

Group I: Efgartigimod PH20 SC Experimental Treatment 1 Intervention

Participants receiving efgartigimod PH20 SC

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University