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

NCT07294170 | Recruiting FDA Drug

• 1 other identifier: ARGX-999-2-MG-2000
• Study Type: observational
• Target: 70
• Locations: 4 countries
• Sites: 10

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.

Conditions

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

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 (1)

ISA1 participants

Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

Biological: Efgartigimod IV; Biological: Empasiprubart IV

Interventions

Efgartigimod IV BIOLOGICAL

Intravenous infusion of efgartigimod

ISA1 participants

Empasiprubart IV BIOLOGICAL

Intravenous infusion of empasiprubart

ISA1 participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• argenx: lead

Study Sites (10)

Profound Research LLC - Carlsbad

Carlsbad, California, 92011, United States

RECRUITING

Visionary Investigators Network

Miami, Florida, 33133, United States

RECRUITING

Erlanger Health System

Columbia, Maryland, 21044, United States

RECRUITING

Dent Neurologic Institute - Amherst

Amherst, New York, 14226, United States

RECRUITING

National Neuromuscular Research Institute

Austin, Texas, 78759, United States

RECRUITING

UZ Leuven - PPDS

Leuven, 3000, Belgium

RECRUITING

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065, Poland

RECRUITING

Krakowska Akademia Neurologii Sp. z o.o.

Krakow, Lesser Poland Voivodeship, 31-505, Poland

RECRUITING

Centrum Medyczne Neurologia Slaska

Katowice, Silesian Voivodeship, 40-689, Poland

RECRUITING

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Malaga, 340120, Spain

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

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: April 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); PL (3); BE (1); ES (1)