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

Part of paid clinical trials in Miami, Florida.

Sponsor
argenx
Study ID
NCT07673627
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empasiprubart IV — BIOLOGICAL
    Intravenous infusions of empasiprubart
  • Placebo IV — OTHER
    Intravenous infusions of placebo
  • Efgartigimod PH20 SC PFS — COMBINATION_PRODUCT
    Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)

Study Details

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

Key Dates

First listed
Jun 29, 2026
Start date
Jul 10, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empasiprubart IV
    Participants receive empasiprubart IV in the DBTP
  • Placebo Comparator: Placebo IV
    Participants receive placebo IV in the DBTP
  • Other: Efgartigimod PH20 SC PFS
    Participants receive open-label efgartigimod PH20 SC PFS in the safety follow-up period

Primary Outcome Measure

Incidence of adverse events and serious adverse events in the DBTP [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Visionary Investigators NetworkMiamiFlorida33176-2148
Andrew Lerman, MD
[email protected]
786-655-8010
Erlanger Health SystemChattanoogaTennessee37403-2136
Joshua Alpers, MD
[email protected]
423-778-3900

Find similar trials in Miami, FL

By research site
Visionary Investigators Network· Miami, FLErlanger Health System· Chattanooga, TN

Related Studies