A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
argenx
Summary
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.
Description
This is a platform study and is governed by a single master protocol that enables multiple regimens to be evaluated in separate intervention-specific appendixes (ISAs). The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration. Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study: * NCT07284420 - ADAPT Forward 1 - a study to evaluate empasiprubart I…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 wi…
Interventions
- BiologicalEfgartigimod IV
Intravenous infusion of efgartigimod
- BiologicalEmpasiprubart IV
Intravenous infusion of empasiprubart
- OtherPlacebo IV
Intravenous infusion of placebo
- BiologicalEfgartigimod PH20 SC PFS
Subcutaneous administration of Efgartigimod PH20 via pre-filled syringe (PFS)
Locations (29)
- Profound Research LLC - CarlsbadCarlsbad, California
- Visionary Investigators NetworkMiami, Florida
- Visionary Investigators NetworkMiami, Florida
- University of South FloridaTampa, Florida
- Erlanger Health SystemColumbia, Maryland
- Massachusetts General HospitalBoston, Massachusetts