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ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

NCT07294170

RecruitingN/A

Sponsor: argenx

Conditions: Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG)

Interventions: Efgartigimod IV, Empasiprubart IV, Placebo IV, Efgartigimod PH20 SC PFS

Countries: United States, Belgium, Germany, Greece, Italy, Japan, Poland, Spain

ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (30)
  • Carlsbad, California, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Amherst, New York, United States
  • Durham, North Carolina, United States
  • Columbus, Ohio, United States
  • Chattanooga, Tennessee, United States
  • Austin, Texas, United States
  • San Antonio, Texas, United States
  • Leuven, Belgium
  • Berlin, Germany
  • Göttingen, Germany
  • Würzburg, Germany
  • Athens, Greece
  • Thessaloniki, Greece
  • Bergamo, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Milan, Italy
  • Naples, Italy
  • Hanamaki, Japan
  • Narita, Japan
  • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Krakow, Lesser Poland Voivodeship, Poland
  • Katowice, Silesian Voivodeship, Poland
  • Warsaw, Poland
  • Málaga, Malaga, Spain
  • Barcelona, Spain