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 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: ARGX-999-2-MG-200012025-522492-28-00
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 9

Brief 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 ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis. The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events and serious adverse events in parts A and B

  Up to 21 weeks

Secondary Outcomes (7)

• MG-ADL total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG ADL total score change from baseline at week 4 in part A

  Up to 18 weeks

• Proportion of participants reaching MSE at any point in part B cycles 1 and 2, and part B cycles 1 or 2

  Up to 21 weeks

• MG-ADL total score changes from baseline over time in part B compared with part A

  Up to 21 weeks

• QMG total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A

  Up to 18 weeks

• QMG total score changes from baseline over time in part B compared with part A

  Up to 21 weeks

Study Arms (2)

Efgartigimod IV + Empasiprubart IV

EXPERIMENTAL

Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B

Biological: Efgartigimod IV; Biological: Empasiprubart IV

Efgartigimod IV (part A + C)

EXPERIMENTAL

Participants not eligible for part B, receiving efgartigimod IV in part A and C

Biological: Efgartigimod IV

Interventions

Efgartigimod IV BIOLOGICAL

Intravenous infusion of efgartigimod

Efgartigimod IV (part A + C); Efgartigimod IV + Empasiprubart IV

Empasiprubart IV BIOLOGICAL

Intravenous infusion of empasiprubart

Efgartigimod IV + Empasiprubart IV

Eligibility Criteria

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

You may qualify if:

• Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)
• Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb
• Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration

You may not qualify if:

• Clinical diagnosis of systemic lupus erythematosus (SLE)
• Any known complement deficiency
• Current administration of a complement inhibitor or received zilucoplan or eculizumab \<2 months or ravulizumab \<6 months before the first study drug administration
• Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)

Sponsors & Collaborators

• argenx: lead

Study Sites (9)

Profound Research LLC - Carlsbad

Carlsbad, California, 92011, United States

RECRUITING

Visionary Investigators Network

Miami, Florida, 33176, United States

RECRUITING

Dent Neurologic Institute - Amherst

Amherst, New York, 14226, United States

RECRUITING

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

RECRUITING

National Neuromuscular Research Institute

Austin, Texas, 78756, United States

RECRUITING

UZ Leuven - PPDS

Leuven, 3000, Belgium

RECRUITING

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

RECRUITING

Centrum Medyczne Neurologia Slaska

Katowice, Silesian Voivodeship, 40-689, Poland

RECRUITING

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Malaga, 29010, 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: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 16, 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); ES (1); BE (1); PL (2)