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Clinical Trials in Spain / NCT07294170
Recruiting Observational

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

NCT07294170 · tracked via the Priya Life Science Spain tracker
Sponsor
argenx
Phase
Observational
Started
2025-12-19
Last updated
2026-09-24

Condition(s) studied

Myasthenia GravisMGgMGGeneralized Myasthenia GravisGeneralized Myasthenia Gravis (gMG)AChR-Ab Seropositive Generalized Myasthenia Gravis

Investigational drug(s) / intervention(s)

Efgartigimod IV →Empasiprubart IV →Placebo IVEfgartigimod PH20 SC PFS

Efgartigimod IV: Intravenous infusion of efgartigimod

Empasiprubart IV: Intravenous infusion of empasiprubart

Placebo IV: Intravenous infusion of placebo

Efgartigimod PH20 SC PFS: Subcutaneous administration of Efgartigimod PH20 via pre-filled syringe (PFS)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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 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

Primary outcome measure(s)

  • 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)

Trial sites (36)

FacilityCityRegionStatus
Profound Research LLC - Carlsbad Carlsbad California Recruiting
Visionary Investigators Network Miami Florida Recruiting
Visionary Investigators Network Miami Florida Recruiting
University of South Florida Tampa Florida Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Profound Research LLC at Las Vegas Neurology Center Las Vegas Nevada Recruiting
Dent Neurologic Institute - Amherst Amherst New York Recruiting
University of North Carolina at Chapel Hill-170 Manning Dr. Chapel Hill North Carolina Recruiting
Duke Early Phase Clinical Research Unit - PPDS Durham North Carolina Recruiting
University of Cincinnati Medical Center - Goodman St Cincinnati Ohio Recruiting
Ohio State Martha Morehouse Outpatient Care Columbus Ohio Recruiting
Erlanger Health System Chattanooga Tennessee Recruiting
National Neuromuscular Research Institute Austin Texas Recruiting
University of Texas- San Antonio - Health Science Center - PPDS San Antonio Texas Recruiting
UZ Leuven - PPDS Leuven Belgium Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Recruiting
Universitätsmedizin Göttingen Göttingen Germany Recruiting
Universitätsklinikum Würzburg Würzburg Germany Recruiting
Eginitio Hospital Athens Greece Recruiting
AHEPA University General Hospital of Thessaloniki Thessaloniki Greece Recruiting
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII Bergamo Lombardy Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Lombardy Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy Recruiting
AORN Antonio Cardarelli Naples Italy Recruiting
University of Tsukuba Hospital Tsukuba Ibaraki Recruiting
St. Marianna University Hospital Kawasaki-Shi Kanagawa Recruiting
National Hospital Organization Sendai Medical Center Sendai Miyagi Recruiting
General Hanamaki Hospital - Kajomachi Hanamaki Japan Recruiting
IUHW Narita Hospital Narita Japan Recruiting
MICS Centrum Medyczne Bydgoszcz Bydgoszcz Kuyavian-Pomeranian Voivodeship Recruiting
Krakowska Akademia Neurologii Sp. z o.o. Krakow Lesser Poland Voivodeship Recruiting
Centrum Medyczne Neurologia Slaska Katowice Silesian Voivodeship Recruiting
Warszawski Uniwersytet Medyczny Warsaw Poland Recruiting
Hospital Regional Universitario de Malaga - Hospital General Málaga Malaga Recruiting
Hospital de La Santa Creu i Sant Pau Barcelona Spain Recruiting

More argenx trials in Spain

A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) Active, not recruiting
A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy Active, not recruiting
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis Active, not recruiting
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa Recruiting
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease. Recruiting

Other trials for the same condition

Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) Recruiting
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Active, not recruiting
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. Active, not recruiting
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa Recruiting
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07294170 on ClinicalTrials.gov ↗ ← All trials in Spain