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
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
argenx · Industry
Who this trial is looking for
This trial is looking for people with a specific type of myasthenia gravis who have certain antibodies in their blood. Participants will receive treatment with empasiprubart to help evaluate its safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with generalized myasthenia gravis.
I have specific antibodies called AChR-Ab.
I am in Myasthenia Gravis Foundation of America Class II, III, IVa, or IVb.
I have received vaccines against certain bacteria in the last 5 years or will get vaccinated before starting treatment.
You may not be able to join if
I have systemic lupus erythematosus.
I am taking complement inhibitors like eculizumab.
I have taken an FcRn antagonist like efgartigimod within the last 4 weeks.
I have previously taken empasiprubart.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 empasiprubar…
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 Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 meningitid…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
