Empasiprubart + Efgartigimod for Myasthenia Gravis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of combining two treatments, empasiprubart and efgartigimod, for individuals with generalized myasthenia gravis (gMG), a condition that causes muscle weakness. The study aims to find the best way to reduce side effects and improve the quality of life for those with this condition. Participants will be divided into groups; some will receive both medications, while others will only receive efgartigimod. Candidates for this trial include those who have tested positive for specific antibodies related to gMG and have been vaccinated against certain infections. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that efgartigimod is generally well-tolerated by people with myasthenia gravis. One study found that 21.45% of patients experienced side effects, mostly mild to moderate. Serious side effects occurred in 4.29% of patients. Notably, efgartigimod is already approved for treating generalized myasthenia gravis, indicating its safety for that condition.
Empasiprubart is being tested with efgartigimod in this study. Since this trial is in Phase 2, empasiprubart has already passed initial safety checks. However, more information is needed to fully understand its safety when used with efgartigimod. The focus remains on ensuring this combination is safe and effective for patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using Efgartigimod and Empasiprubart for treating Myasthenia Gravis because they bring new approaches to managing this condition. Unlike standard treatments like cholinesterase inhibitors or immunosuppressants, Efgartigimod works by reducing antibodies that attack healthy cells, offering a targeted approach. Empasiprubart adds another layer by potentially modulating the immune response through a different mechanism, which could enhance effectiveness. This combination aims to provide more precise and potentially faster relief from symptoms compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for myasthenia gravis?
Research shows that efgartigimod helps treat myasthenia gravis. In studies, patients experienced noticeable improvements in muscle strength and daily activities with efgartigimod compared to standard treatments. Specifically, scores measuring daily living activities and muscle strength improved.
For empasiprubart, early data from other conditions suggest it might reduce the need for additional treatments and improve outcomes, but more research is needed to confirm its effects on myasthenia gravis. In this trial, one group of participants will receive both efgartigimod and empasiprubart to test their combined effectiveness, while another group will receive efgartigimod alone.23678Are You a Good Fit for This Trial?
This trial is for people with a confirmed diagnosis of generalized Myasthenia Gravis (MG), specifically those who are positive for anti-acetylcholine receptor antibodies and fall under MGFA Class II to IVb. Participants must have had or agree to get vaccinated against certain bacterial pathogens before starting the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in Period (Part A)
Participants receive efgartigimod IV to establish baseline response
Add-on Period (Part B)
Participants receive both efgartigimod IV and empasiprubart IV
Safety Follow-up Period (Part C)
Participants receive efgartigimod IV only for safety monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Efgartigimod
- Empasiprubart
Trial Overview
The ADAPT Forward 1 - ISA1 study is testing Empasiprubart IV as an additional treatment alongside Efgartigimod IV in patients with generalized Myasthenia Gravis who partially responded to Efgartigimod alone, aiming to improve safety and quality of life.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B
Participants not eligible for part B, receiving efgartigimod IV in part A and C
Find a Clinic Near You
Who Is Running the Clinical Trial?
argenx
Lead Sponsor
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University
Citations
an interim analysis of Japanese post-marketing surveillance
In real-world settings, efgartigimod-IV was well tolerated and effective in patients with gMG.
Efficacy and safety of efgartigimod versus intravenous ...
From weeks 2–4, the efgartigimod group showed significantly greater improvements in MG-ADL and QMG scores (both P < 0.05), with a similar trend after baseline ...
argenx Presents New Data at AANEM and MGFA ...
In the overall population, mean change from baseline in patients treated with VYVGART was a clinically meaningful 3.35 point improvement in MG- ...
Efgartigimod Outperforms Standard IVIG in Averting ...
Efgartigimod shows promising efficacy over IV immunoglobulin in treating impending myasthenic crisis in patients with myasthenia gravis.
Study Details | NCT07284420 | ADAPT Forward 1 - ISA1
The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with ...
The efficacy and safety of efgartigimod for refractory ...
Our study demonstrates that efgartigimod is highly effective and well-tolerated in patients with refractory MG. These findings suggest that ...
Full article: Safety and effectiveness of efgartigimod for ...
Adverse drug reaction and serious adverse drug reaction were reported in 21.45% (80/373) and 4.29% (16/373) of patients, respectively. Although six deaths were ...
Overview of the Safety Profile from Efgartigimod Clinical ...
Conclusions: Efgartigimod is well tolerated across indications and doses studied. Most TEAEs, including infections, were mild or moderate in severity and did ...
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