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

May 29, 2026 updated by: argenx

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a platform study and is governed by a single master protocol that enables multiple regimens to be evaluated in separate intervention-specific appendixes (ISAs).

The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration.

Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study:

  • NCT07284420 - ADAPT Forward 1 - a study to evaluate empasiprubart IV as add-on therapy to efgartigimod IV in participants with AChR-Ab seropositive generalized myasthenia gravis with a partial clinical response to efgartigimod (https://www.clinicaltrials.gov/study/NCT07284420)

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
  • Italy
    • Lombardy
      • Bergamo, Lombardy, Italy, 24127
        • Active, not recruiting
        • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-065
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-505
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-689
  • Spain
    • Malaga
      • Málaga, Malaga, Spain, 340120
        • Recruiting
        • Hospital Regional Universitario de Malaga - Hospital General
        • Contact:
  • United States
    • California
      • Carlsbad, California, United States, 92011
        • Recruiting
        • Profound Research LLC - Carlsbad
        • Contact:
    • Florida
      • Miami, Florida, United States, 33133
        • Recruiting
        • Visionary Investigators Network
        • Contact:
      • Tampa, Florida, United States, 33620
        • Active, not recruiting
        • University of South Florida
    • Maryland
      • Columbia, Maryland, United States, 21044
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute - Amherst
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43221-3502
        • Active, not recruiting
        • Ohio State Martha Morehouse Outpatient Care
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403-2136
        • Active, not recruiting
        • Erlanger Health System
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • National Neuromuscular Research Institute
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • University of Texas- San Antonio - Health Science Center - PPDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ISA1 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
Biological: Efgartigimod IV
Intravenous infusion of efgartigimod
Biological: Empasiprubart IV
Intravenous infusion of empasiprubart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy 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)
Each ISA record will specify the correct scale and time point
Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2025

Primary Completion (Estimated)

March 7, 2028

Study Completion (Estimated)

March 7, 2028

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-999-2-MG-2000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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