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

Part of paid clinical trials in Carlsbad, California.

Sponsor
argenx
Study ID
NCT07294170
Status
Recruiting

Conditions

  • AChR-Ab Seropositive Generalized Myasthenia Gravis
  • Generalized Myasthenia Gravis
  • Generalized Myasthenia Gravis (gMG)
  • MG
  • Myasthenia Gravis
  • gMG

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod IV — BIOLOGICAL
    Intravenous infusion of efgartigimod
  • Empasiprubart IV — BIOLOGICAL
    Intravenous infusion of empasiprubart

Study Details

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.

Key Dates

Start date
Dec 19, 2025
Status verified
Feb 2026
Primary completion
Mar 7, 2028
Completion
Mar 7, 2028

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: ISA1 participants
    Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

Primary Outcome Measure

To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes [ Time Frame: Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Profound Research LLC - CarlsbadCarlsbadCalifornia92011
Gregory Sahagian, MD
760-732-0557
Visionary Investigators NetworkMiamiFlorida33133
Andrew Lerman, MD
786-655-8010
University of South FloridaTampaFlorida33620
Tuan Vu, MD
(813) 974-9413
Erlanger Health SystemColumbiaMaryland21044
Joshua Alpers, MD
857-350-4834
Dent Neurologic Institute - AmherstAmherstNew York14226
Luisa Rojas Estupinan, MD
716-250-2000
Ohio State Martha Morehouse Outpatient CareColumbusOhio43221-3502
Miriam Freimer, MD
614-293-4969
Erlanger Health SystemChattanoogaTennessee37403-2136
Joshua Alpers, MD
423-778-3900
National Neuromuscular Research InstituteAustinTexas78759
Yessar Hussain, MD
512-920-0140
University of Texas- San Antonio - Health Science Center - PPDSSan AntonioTexas78229
Ratna Bhavaraju-Sanka, MD
210-567-8229

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