ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ADAPT Forward uses a single master protocol that lets multiple intervention-specific appendices (ISAs) run under the same overall framework. The design includes a common master screening period, ISA-specific screening, an ISA treatment period of variable duration and design, and ISA safety follow-up periods. The initial ISA will test empasiprubart IV as an add-on to efgartigimod IV in AChR-antibody positive participants with a partial response to efgartigimod. Sites in California, Florida, and Maryland will follow ISA-specific procedures for enrollment, treatment, and follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Is at least 18 years of age and the local legal age of consent for clinical studies
* Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment
* If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening

Exclusion Criteria:

* Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk
* Is MGFA (Myasthenia Gravis Foundation of America) Class V

Where it's running

• Profound Research LLC - Carlsbad
  Carlsbad, California, United States Recruiting
• Visionary Investigators Network
  Miami, Florida, United States Recruiting
• Visionary Investigators Network
  Miami, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Henry Ford Health System
  Detroit, Michigan, United States Recruiting

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adding empasiprubart to efgartigimod for AChR-antibody positive generalized myasthenia gravis

  This trial will test whether adding empasiprubart to efgartigimod infusions helps people with AChR-antibody positive generalized myasthenia gravis who have only had a partial response to efgartigimod.

  Recruiting at 33 sites Phase 2 argenx · Carlsbad, California and 32 other locations · NCT07284420

• MG patient registry to track long-term experiences and treatment patterns

  This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.

  Recruiting Autoimmune Neurology Alliance · Framingham, Massachusetts · NCT07761026

• Empasiprubart IV in people with AChR-Ab positive generalized myasthenia gravis

  This study tests whether empasiprubart given by IV can help people with AChR-Ab positive generalized myasthenia gravis feel better and have fewer symptoms.

  Recruiting at 14 sites Phase 2 argenx · Carlsbad, California and 13 other locations · NCT07673627

• Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults

  This trial tests ravulizumab in Chinese adults with generalized myasthenia gravis to see if it helps symptoms while checking safety and how the drug behaves in the body.

  Recruiting at 8 sites Phase 3 Alexion Pharmaceuticals, Inc. · Beijing and 9 other locations · NCT07596784

• Impact of efgartigimod on overall disease experience in adults with generalized myasthenia gravis in Italy

  This study looks at real-world use of efgartigimod in adults with generalized myasthenia gravis to see how it affects their daily symptoms and experiences.

  Recruiting at 30 sites argenx · Acquaviva delle Fonti and 29 other locations · NCT07595653

• Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.

  This study will try a predefined prednisone taper to see if adults with generalized myasthenia gravis on ravulizumab can safely reduce their daily steroid dose.

  Recruiting Phase 4 Alexion Pharmaceuticals, Inc. · Chicago, Illinois and 11 other locations · NCT07221838

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.