Efgartigimod + Empasiprubart 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 two intravenous drugs, efgartigimod and empasiprubart, for treating myasthenia gravis, a condition that causes muscle weakness. The main goal is to find the best way to reduce side effects and improve the quality of life for those affected. It targets individuals with generalized myasthenia gravis who continue to experience symptoms despite current treatment. Participants should maintain a stable dosage of their current myasthenia gravis medication. The trial is not suitable for those with other autoimmune diseases that could complicate the results. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in myasthenia gravis treatment.
Do I have to stop taking my current medications for the trial?
You can continue taking your current medications for myasthenia gravis, but you need to be on a stable dosage before the trial starts.
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 generalized myasthenia gravis. Most participants did not experience severe side effects. Some reported mild issues like headaches or infections, but these were uncommon. The FDA has approved this treatment for myasthenia gravis, indicating a good safety record.
Research on empasiprubart is ongoing to assess its safety when used with efgartigimod. So far, no major safety concerns have emerged. Since empasiprubart remains under study, researchers closely monitor for any side effects. Participants in earlier studies tolerated it without serious problems.
Overall, both treatments appear safe based on current findings, but ongoing studies will provide more detailed safety information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Efgartigimod and Empasiprubart for treating Myasthenia Gravis because these treatments offer a fresh approach compared to current options like immunosuppressants and acetylcholinesterase inhibitors. Efgartigimod works by reducing the antibodies that attack the body's own muscles, providing a more targeted and potentially effective treatment. Empasiprubart, on the other hand, is a novel compound that may work synergistically with Efgartigimod to enhance its effects and improve patient outcomes. Together, these treatments aim to provide faster and more durable symptom relief for patients who have not fully responded to existing therapies.
What evidence suggests that this trial's treatments could be effective for myasthenia gravis?
Studies have shown that efgartigimod effectively treats myasthenia gravis, a condition causing muscle weakness. Patients receiving efgartigimod experienced noticeable improvements in muscle strength and daily activities. Specifically, 91.7% of patients observed benefits, with some improvements appearing as soon as one week after starting treatment. In this trial, participants will receive efgartigimod. Although research on empasiprubart is less extensive, it indicates potential benefits when used alongside treatments like efgartigimod. Empasiprubart has shown promise in reducing the need for other treatments and improving muscle function in similar conditions. Together, these treatments aim to enhance the quality of life for those with myasthenia gravis.26789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
ISA-specific Screening
Participants undergo additional screening specific to each intervention-specific appendix (ISA)
ISA Treatment
Participants receive treatment as specified in each ISA, which may include different regimens
ISA Safety Follow-up
Participants are monitored for safety and effectiveness after treatment as specified in each ISA
Long-term Follow-up
Participants are monitored for long-term outcomes and safety
What Are the Treatments Tested in This Trial?
Interventions
- Efgartigimod IV
- Empasiprubart IV
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
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
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 for generalized myasthenia gravis in the ...
Under efgartigimod treatment, CMI was rapidly achieved in 91.7% (11/12) of patients, with a mean time of 1.3 ± 0.5 weeks. However, two patients ...
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 ...
Efgartigimod Outperforms Standard IVIG in Averting ...
Efgartigimod shows promising efficacy over IV immunoglobulin in treating impending myasthenic crisis in patients with myasthenia gravis.
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neurologyadvisor.com
neurologyadvisor.com/news/efgartigimod-iv-beneficial-achr-ab-seronegative-generalized-myasthenia-gravis/Efgartigimod IV Beneficial in AChR-Ab Seronegative ...
Findings showed treatment with efgartigimod IV was associated with a statistically significant and clinically meaningful improvement in MG-ADL ...
Efficacy, Safety, and Tolerability of Efgartigimod in AChR- ...
There were no study visits during weeks 4-6 in ADAPT+. ADAPT. ADAPT+. MSE c. Cycle 1. 31.6%.
NCT06298552 | A Phase 3 Study to Evaluate the Efficacy ...
The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor ...
The efficacy and safety between efgartigimod ...
First comparative study evaluating safety/efficacy of efgartigimod vs IVIg in AChR-Ab(+) generalized myasthenia gravis (gMG), addressing current evidence gaps ...
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 ...
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