NCT07673627

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 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
20mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Apr 2028

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

July 10, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

June 23, 2026

Last Update Submit

July 23, 2026

Conditions

Myasthenia Gravis (MG)MG - Myasthenia GravisgMGAChR-Ab Seropositive Generalized Myasthenia Gravis

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events and serious adverse events in the DBTP

    Up to 12 weeks

Secondary Outcomes (9)

  • MG-ADL total score change from baseline at week 12

    Up to 12 weeks

  • QMG total score change from baseline at week 12

    Up to 12 weeks

  • MG-ADL total score change from baseline over time up to week 12

    Up to 12 weeks

  • QMG total score change from baseline over time up to week 12

    Up to 12 weeks

  • Proportion of participants reaching MSE at any point by week 12

    Up to 12 weeks

  • +4 more secondary outcomes

Study Arms (3)

Empasiprubart IV

EXPERIMENTAL

Participants receive empasiprubart IV in the DBTP

Biological: Empasiprubart IV

Placebo IV

PLACEBO COMPARATOR

Participants receive placebo IV in the DBTP

Other: Placebo IV

Efgartigimod PH20 SC PFS

OTHER

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

Combination Product: Efgartigimod PH20 SC PFS

Interventions

Placebo IVOTHER

Intravenous infusions of placebo

Placebo IV
Empasiprubart IVBIOLOGICAL

Intravenous infusions of empasiprubart

Empasiprubart IV
Efgartigimod PH20 SC PFSCOMBINATION_PRODUCT

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

Efgartigimod PH20 SC PFS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 before ISA screening or will complete immunization at least 14 days before the first IMP administration.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Visionary Investigators Network

Miami, Florida, 33176-2148, United States

RECRUITING

Erlanger Health System

Chattanooga, Tennessee, 37403-2136, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834clinicaltrials@argenx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)