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

Purpose

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

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Empasiprubart IV 		Participants receive empasiprubart IV in the DBTP
  • Biological: Empasiprubart IV
    Intravenous infusions of empasiprubart
Placebo Comparator
Placebo IV 		Participants receive placebo IV in the DBTP
  • Other: Placebo IV
    Intravenous infusions of placebo
Other
Efgartigimod PH20 SC PFS 		Participants receive open-label efgartigimod PH20 SC PFS in the safety follow-up period
  • Combination Product: Efgartigimod PH20 SC PFS
    Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)

Recruiting Locations

Visionary Investigators Network
Miami, Florida 33176-2148
Contact:
Andrew Lerman, MD
786-655-8010
alerman@fcneurology.net

Erlanger Health System
Chattanooga, Tennessee 37403-2136
Contact:
Joshua Alpers, MD
423-778-3900
Joshua.Alpers@erlanger.org

More Details

Status
Recruiting
Sponsor
argenx

Study Contact

Sabine Coppieters, MD
857-350-4834
clinicaltrials@argenx.com

Detailed 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.