RecruitingPhase 2NCT07673627

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

ISA2 to Master Protocol ARGX-999-2-MG-2000 - an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis


Sponsor

argenx

Enrollment

40 participants

Start Date

Jul 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is part of the ADAPT Forward platform study (NCT07294170). 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. The aim of this ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG). The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170 More information can be found here: https://clinicaltrials.argenx.com/adaptforward2


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Efgartigimod PH20 SC PFS, a biological treatment called Empasiprubart IV, and others for people with achr-ab seropositive generalized myasthenia gravis, mg - myasthenia gravis, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEmpasiprubart IV

Intravenous infusions of empasiprubart

OTHERPlacebo IV

Intravenous infusions of placebo

COMBINATION_PRODUCTEfgartigimod PH20 SC PFS

Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)


Locations(2)

Visionary Investigators Network

Miami, Florida, United States

Erlanger Health System

Chattanooga, Tennessee, United States

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NCT07673627


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