ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
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
1 other identifier
observational
70
8 countries
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2025
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedStudy Start
First participant enrolled
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 7, 2028
July 30, 2026
July 1, 2026
2.2 years
December 8, 2025
July 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes
Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)
Secondary Outcomes (1)
To evaluate the efficacy of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes
Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)
Study Arms (2)
ISA1 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
ISA2 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
Interventions
Subcutaneous administration of Efgartigimod PH20 via pre-filled syringe (PFS)
Eligibility Criteria
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- argenxlead
Study Sites (29)
Profound Research LLC - Carlsbad
Carlsbad, California, 92011, United States
Visionary Investigators Network
Miami, Florida, 33133, United States
Visionary Investigators Network
Miami, Florida, 33180, United States
University of South Florida
Tampa, Florida, 33620, United States
Erlanger Health System
Columbia, Maryland, 21044, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621, United States
Henry Ford Health System
Detroit, Michigan, 48202-2608, United States
Dent Neurologic Institute - Amherst
Amherst, New York, 14226, United States
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, 27710-0001, United States
Ohio State Martha Morehouse Outpatient Care
Columbus, Ohio, 43221-3502, United States
Erlanger Health System
Chattanooga, Tennessee, 37403-2136, United States
Erlanger Neuroscience Institute
Chattanooga, Tennessee, 37403-2173, United States
National Neuromuscular Research Institute
Austin, Texas, 78759, United States
University of Texas- San Antonio - Health Science Center - PPDS
San Antonio, Texas, 78229, United States
UZ Leuven - PPDS
Leuven, 3000, Belgium
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Eginitio Hospital
Athens, 115 28, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36, Greece
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, Lombardy, 24127, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, 20133, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
AORN Antonio Cardarelli
Naples, 80131, Italy
IUHW Narita Hospital
Narita, 286-8520, Japan
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065, Poland
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-505, Poland
Centrum Medyczne Neurologia Slaska
Katowice, Silesian Voivodeship, 40-689, Poland
Warszawski Uniwersytet Medyczny
Warsaw, 00-665, Poland
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, 340120, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, 8041, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2025
First Posted
December 19, 2025
Study Start
December 19, 2025
Primary Completion (Estimated)
March 7, 2028
Study Completion (Estimated)
March 7, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share