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

ClinicalTrials.gov ID

NCT07294170

Lead Sponsor

argenxINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

70Estimated

Last Update Posted

Aug 21, 2026Actual

Start Date

Dec 19, 2025Actual

Primary Completion Date

Mar 7, 2028Estimated

Completion Date

Mar 7, 2028Estimated

Official Title

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

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.

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)
• NCT07673627 - Adapt Forward 2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis (https://clinicaltrials.gov/study/NCT07673627)

More information can be found here: https://clinicaltrials.argenx.com/adaptforward

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

• Efgartigimod IV
• Empasiprubart IV
• Placebo IV
• Efgartigimod PH20 SC PFS

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

argenxINDUSTRY

kristi.claeys@uzleuven.be+3216344278

clinicaltrials@argenx.com857-350-4834

j.zschuentzsch@med.uni-goettingen.de+49 551 39 67273

haarmann_a@ukw.de+4993120123595

clinicaltrials@argenx.com857-350-4834

francesco.habetswallner@aocardarelli.it

murai@iuhw.ac.jp

anna.kostera-pruszczyk@wum.edu.pl+48 22 599 2858

clinicaltrials@argenx.com857-350-4834

• ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

  NCT07673627

  RecruitingInterventionalPhase 2Updated Aug 21, 2026
• ADAPT Forward 1 - ISA1 - 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

  NCT07284420

  RecruitingInterventionalPhase 2Updated Aug 21, 2026
• A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

  NCT06909214

  RecruitingInterventionalPhase 4Updated Mar 10, 2026
• A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

  NCT06298552

  Active, not recruitingInterventionalPhase 3Updated Aug 10, 2026
• Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

  NCT04818671

  CompletedInterventionalPhase 3Updated Jan 22, 2026
• Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

  NCT04735432

  CompletedInterventionalPhase 3Updated Feb 28, 2023