Actively Recruiting

Age: 18Years +
All Genders
ID07294170

A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

Led by argenx · Updated on 2026-06-03

70

Participants Needed

15

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of different drug regimens in people with myasthenia gravis, a condition affecting muscle strength. The study aims to find the best treatment options that reduce side effects and improve quality of life. It uses a master protocol to test multiple treatments in separate groups called intervention-specific appendixes (ISAs). The platform study includes a common screening period and ISA-specific screening, treatment, and safety follow-up periods. One ISA focuses on adding empasiprubart intravenous infusion to efgartigimod intravenous infusion for participants with generalized myasthenia gravis who have a partial response to efgartigimod. Each ISA has its own schedule and duration. Participants will undergo screening, receive assigned treatments, and be monitored for safety and treatment effects over up to approximately seven years, depending on the ISA. Researchers will assess safety, tolerability, and how well the treatments work for different myasthenia gravis subtypes during the study periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Is at least 18 years of age and the local legal age of consent for clinical studies
  • Has been diagnosed with myasthenia gravis with consistent clinical features per investigator's judgment
  • If receiving MG therapy (nonsteroidal immunosuppressive drugs, corticosteroids, or acetylcholinesterase inhibitors), dosage should be stable before screening
Not Eligible

You will not qualify if you...

  • Has known autoimmune disease or other medical condition that interferes with MG symptom assessment or increases risk
  • Is Myasthenia Gravis Foundation of America Class V

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 7 years (varies by regimen)

Participants receive intravenous infusions of study regimens, including monotherapy or add-on therapy to backbone therapy, to evaluate safety, tolerability, and efficacy in myasthenia gravis subtypes.

Visit schedule varies per regimen and is specified in intervention-specific appendixes

Safety Follow-up

Duration - Variable duration as specified in intervention-specific appendixes

Participants are monitored for safety and tolerability after the treatment period ends.

Visit schedule varies according to safety follow-up requirements

Trial Site Locations

Total: 15 locations

1

Profound Research LLC - Carlsbad

Carlsbad, California, United States, 92011

Actively Recruiting

2

Visionary Investigators Network

Miami, Florida, United States, 33133

Actively Recruiting

3

University of South Florida

Tampa, Florida, United States, 33620

Actively Recruiting

4

Erlanger Health System

Columbia, Maryland, United States, 21044

Actively Recruiting

5

Dent Neurologic Institute - Amherst

Amherst, New York, United States, 14226

Actively Recruiting

6

Ohio State Martha Morehouse Outpatient Care

Columbus, Ohio, United States, 43221-3502

Actively Recruiting

7

Erlanger Health System

Chattanooga, Tennessee, United States, 37403-2136

Actively Recruiting

8

National Neuromuscular Research Institute

Austin, Texas, United States, 78759

Actively Recruiting

9

University of Texas- San Antonio - Health Science Center - PPDS

San Antonio, Texas, United States, 78229

Actively Recruiting

10

UZ Leuven - PPDS

Leuven, Belgium, 3000

Actively Recruiting

11

ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, Italy, 24127

Actively Recruiting

12

MICS Centrum Medyczne Bydgoszcz

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

Actively Recruiting

13

Krakowska Akademia Neurologii Sp. z o.o.

Krakow, Lesser Poland Voivodeship, Poland, 31-505

Actively Recruiting

14

Centrum Medyczne Neurologia Slaska

Katowice, Silesian Voivodeship, Poland, 40-689

Actively Recruiting

15

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Malaga, Spain, 340120

Actively Recruiting

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Research Team

S

Sabine Coppieters, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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