Nipocalimab vs Efgartigimod for Myasthenia Gravis

(EPIC Trial)

Recruiting at 1 trial location

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: Efgartigimod

Must not be taking: IgG monoclonal antibodies

Disqualifiers: Immunodeficiency, Thymectomy, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, nipocalimab (an experimental treatment) and efgartigimod (a new potential drug), to determine which is more effective for people with generalized myasthenia gravis. Myasthenia gravis occurs when the immune system attacks the connection between nerves and muscles, causing muscle weakness. Participants will receive either nipocalimab every two weeks or efgartigimod weekly, with some possibly switching treatments during the trial. Ideal candidates are those diagnosed with generalized myasthenia gravis who experience muscle weakness and have not responded well to their current treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potential new treatment option.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nipocalimab is generally safe and well-tolerated for people with generalized myasthenia gravis. In previous studies, patients experienced symptom improvements with only a few side effects, which were usually mild and temporary.

For efgartigimod, current data indicate it is an important treatment option for myasthenia gravis. However, some reports suggest a potential risk of infections. These infections occurred in some patients but were neither common nor severe.

Both nipocalimab and efgartigimod have shown promise in helping people with myasthenia gravis, with manageable safety profiles. This suggests they are likely safe for most people, but monitoring for any side effects during treatment remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about nipocalimab and efgartigimod for treating Myasthenia Gravis because they offer unique approaches compared to traditional therapies. Unlike standard treatments like cholinesterase inhibitors and immunosuppressants, nipocalimab works by targeting the neonatal Fc receptor (FcRn), which plays a role in the immune system's regulation of antibodies. Efgartigimod also targets FcRn, but it acts differently by blocking the receptor to reduce pathogenic antibodies. Both treatments have the potential to provide more targeted immunotherapy, which could lead to improved effectiveness with fewer side effects, offering new hope for those with Myasthenia Gravis.

What evidence suggests that this trial's treatments could be effective for myasthenia gravis?

This trial will compare Nipocalimab and Efgartigimod for treating generalized myasthenia gravis (gMG). Studies have shown that Nipocalimab, which participants in this trial may receive, can lead to lasting improvement in gMG symptoms by reducing harmful antibodies for up to 18 months. This reduction may provide patients with long-term relief from muscle weakness. Evidence suggests that Nipocalimab is generally well-tolerated by people with gMG.

Meanwhile, research has shown that Efgartigimod significantly improves muscle function in gMG patients. In one study, 68% of patients experienced better Myasthenia Gravis symptoms after treatment. Efgartigimod appears to help many people by lowering specific antibodies that cause muscle weakness. Both treatments have shown promise in improving life for those with gMG. ^{4 6 7 8 9}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for people with generalized myasthenia gravis, a condition where the immune system weakens muscles. Participants must have been diagnosed according to specific criteria and have a certain level of daily living impairment. They should be medically stable and not responding well to current treatments or unable to take them due to side effects.

Inclusion Criteria

I have been diagnosed with generalized myasthenia gravis and test positive for AChR antibodies.

I have a MG-ADL score of 5 or more, with less than half of my symptoms being eye-related.

My current treatment for myasthenia gravis isn't working well, or I stopped certain medications due to side effects or they didn't work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nipocalimab or efgartigimod intravenously. Nipocalimab is administered at a loading dose on Day 1 followed by maintenance dosing every 2 weeks until Week 12. Efgartigimod is administered once a week for 4 weeks starting from Day 1.

12 weeks

Weekly visits for efgartigimod, bi-weekly visits for nipocalimab

Treatment Switch

Participants previously treated with efgartigimod may switch to nipocalimab, receiving a loading dose on Switch Day 1 followed by maintenance dosing every 2 weeks until Switch Week 12.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nipocalimab
• Efgartigimod

Trial Overview The study compares two drugs, Nipocalimab and Efgartigimod, for treating muscle weakness in myasthenia gravis patients. It aims to determine which drug works better at improving symptoms.

How Is the Trial Designed?

Group I: Arm 3: Treatment Switch (Nipocalimab) Experimental Treatment 1 Intervention

Participants previously treated with efgartigimod, who are directly enrolled in this arm, and eligible participants switching from Arm 2 will receive nipocalimab IV at a loading dose on Switch Day 1 followed by maintenance dosing q2w until Switch Week 12.

Group II: Arm 1: Nipocalimab Experimental Treatment 1 Intervention

Participants will receive nipocalimab intravenously (IV), at a loading dose on Day 1 followed by maintenance dosing once every 2 weeks (q2w) until Week 12.

Group III: Arm 2: Efgartigimod Active Control 1 Intervention

Participants will receive efgartigimod IV, once a week for 4 weeks starting from Day 1. Eligible participants will be given the option to switch to Arm 3 between Week 8 and Week 12.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. argenx.com argenx.com/news/2025/press-release-3176635

argenx Presents New Data at AANEM and MGFA ... Improvements in MG-ADL and QMG (Quantitative Myasthenia Gravis score) among patients treated with VYVGART were increasingly pronounced across ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12366048/

The efficacy and safety of efgartigimod for refractory ... The results indicate that the variability in efgartigimod efficacy can be attributed to diversity in antibody phenotypes. In the phase III ADAPT ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000208765

Outcomes for Patients with Generalized Myasthenia Gravis ... Despite varying patient characteristics, results suggest both treatments improved patient outcomes and decreased OCS dosing.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925002089

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 ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1472845/full

Efgartigimod treatment for generalized myasthenia gravis In a phase 3 randomized controlled trial (ADAPT trial), 68% of patients receiving efgartigimod treatment showed improvement in Myasthenia Gravis ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12258281/

Postmarketing adverse events of efgartigimod alfa: a real- ... Efgartigimod alfa is an important novel drug for the treatment of myasthenia gravis. However, postmarketing safety data for this drug is limited ...

7. neurologylive.com neurologylive.com/view/evaluating-risk-clarifying-safety-data-behind-efgartigimod

Clarifying the Safety Data Behind Efgartigimod Josh Bryson, PhD, head of Medical Affairs at Argenx, discussed the safety profile of efgartigimod in light of recent FAERS-based infection data.

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000211132

Infections-related Safety Profile of Efgartigimod Alpha and ... This analysis identified a potential risk of infections in myasthenia gravis patients treated with efgartigimod alfa or immunoglobulins in clinical practice.

9. imaavyhcp.com imaavyhcp.com/generalized-myasthenia-gravis/efficacy-and-safety/

Efficacy & Safety in Generalized Myasthenia Gravis View the efficacy and safety data for IMAAVY™ (nipocalimab-aahu) in the treatment of generalized myasthenia gravis. See full prescribing and safety information.