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 (ADAPT Forward2)

argenx

Status and phase: Enrolling; Phase 2

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

Treatments: Combination Product: Efgartigimod PH20 SC PFS; Other: Placebo IV; Biological: Empasiprubart IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT07673627

ARGX-999-2-MG-20002

2025-522939-33-00 (EU Trial (CTIS) Number)

2025

Details and patient eligibility

About

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

Full description

Once the master protocol and ISA2 screening periods are completed, eligible participants will be randomized to receive empasiprubart IV or placebo in the double-blinded treatment period (DBTP). All participants will then receive open-label efgartigimod PH20 SC PFS in the safety follow-up period.

The study duration for each participant is approximately up to 45 weeks.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 before ISA screening or will complete immunization at least 14 days before the first IMP administration.

Exclusion criteria

• Clinical diagnosis of systemic lupus erythematosus (SLE).
• Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab >2 months or ravulizumab >6 months before baseline are allowed to participate.
• Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline.
• Had prior empasiprubart exposure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups, including a placebo group

Empasiprubart IV

Experimental group

Description:

Participants receive empasiprubart IV in the DBTP

Treatment:

Biological: Empasiprubart IV

Placebo IV

Placebo Comparator group

Description:

Participants receive placebo IV in the DBTP

Treatment:

Other: Placebo IV

Efgartigimod PH20 SC PFS

Other group

Description:

Participants receive open-label efgartigimod PH20 SC PFS in the safety follow-up period

Treatment:

Combination Product: Efgartigimod PH20 SC PFS