Nolan Campbell, PhD, U.S. Medical Director at Johnson & Johnson, discusses the EPIC clinical trial design that will evaluate the efficacy of nipocalimab versus efgartigimod in patients with generalized myasthenia gravis (gMG).
gMG is a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles due to antibodies attacking the acetylcholine receptors in the neuromuscular junction. Common symptoms include weakness of the muscles that control the eye and eyelid, facial expressions, chewing, talking, and swallowing. Weakness tends to increase during periods of activity and improve after periods of rest. The condition results from a defect in the transmission of nerve impulses to muscles, which is due to the presence of antibodies against acetylcholine. The exact reason this occurs is not known. Some cases have been linked to tumors in the thymus gland. Some cases may go into remission temporarily, and muscle weakness may disappear so that medications can be discontinued.
Nipocalimab is a fully human neonatal FcRn inhibitor that enables the reduction of circulating IgG levels. It was approved earlier this year for the treatment of gMG following positive data from the Vibrance-MG clinical trial.
New data addressing unmet medical needs within the indication of nipocalimab was recently presented at the 2025 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session.
EPIC Clinical Trial Design
Efgartigimod is another FDA-approved FcRn-targeting treatment for gMG with differing molecular structures, binding affinities, and dosing to nipocalimab. EPIC (NCT07217587) is a phase 3b, multicenter, randomized, open-label, active-controlled interventional study with parallel-group design including treatment switching in adult participants with gMG.
The objective of EPIC aims to evaluate the efficacy of nipocalimab versus efgartigimod in participants initiating FcRn targeted therapy for gMG and to evaluate efficacy and safety of nipocalimab in participants switching from efgartigimod to nipocalimab. The study will consist of a screening phase of up to 32 days, a 12-week randomized open-label head-to-head phase (Arms 1 and 2) or an up to 12-week run-in phase and a 12-week open-label treatment switch phase (Arm 3), and an 8-week safety follow-up phase.
The study’s key primary and secondary endpoints are change from baseline in total immunoglobulin G (IgG) levels and sustained disease control measured by MG Activities of Daily Living and Quantitative MG scores 8-12 weeks post-initiation of treatment, respectively.
Insights and Challenges From Mapping Out the Patient Journey of gMG
Another study discussed at AANEM 2025 looked at the patient journey and further characterized the experience of living with gMG using key patient and caregiver insights from a pre-session survey and focus group discussions. There was a total of 16 participants, with 12 being patients and 4 caregivers.
Common challenges participants faced in the gMG patient journey included misdiagnosis or delayed diagnosis, insurance barriers, and the trial-and-error nature of finding effective treatments. Most participants described gMG as an emotionally challenging disease, due in part to self-doubt caused by HCPs not believing them, grief for lost abilities, and the emotional toll on caregivers of patients with gMG. Implementing self-care practices, finding support groups, and learning to identify limitations and triggers and express them to others were strategies participants utilized to improve their patient journey and protect their mental health. Leveraging these insights may help to improve gMG management and patient outcomes, as US patients with gMG continue to experience substantial disease instability despite currently available treatment options.
For more information, click here.
To learn more about gMG and other rare musculoskeletal conditions, visit https://checkrare.com/diseases/musculoskeletal-diseases/