A Clinical Study for Adults with AChR-Antibody Seronegative Generalized Myasthenia Gravis

If you have adult patients living with the rarest forms of generalized myasthenia gravis

They may qualify to participate in the ADAPT SERON clinical study

Who Can Join?

Consider the ADAPT SERON clinical study for your adult patients with AChR-antibody seronegative generalized myasthenia gravis, a patient population that includes:

MuSK-Ab
LRP4-Ab
gMG patients with no identifiable autoantibodies

Trial Size

We are recruiting approximately 110 adult participants for ADAPT SERON, a randomized, double-blinded, placebo-controlled, Phase 3, parallel-group design study evaluating the efficacy and safety of efgartigimod as an intravenous infusion.

Study Drug

Efgartigimod is being evaluated for severe autoimmune diseases mediated by pathogenic IgG autoantibodies, including gMG.

The investigational study drug, efgartigimod, is not approved by the FDA for the treatment of patients with AChR-Ab seronegative gMG as efficacy and safety have not been established.

See if your patients can be part of this research

KEY Eligibility Criteria

Patient is an adult
Patient is not pregnant or plans to become pregnant
Patient has no known weakness in infancy and later develop fatigable weakness after aged 16 years and diagnosed with acquired gMG confirmed by documentation of both of the following:

– HHistory of abnormal neuromuscular transmission demonstrated by single fiber electromyography or RNS or is MuSK-Ab seropositive
– Either a history of positive edrophonium chloride test OR a demonstrated improvement in MG signs with treatments such as oral AChE inhibitors, PLEX, immunoabsorption, or IVIg/SCIg treatment

Patient is AChR-Ab seronegative at screening
Patient is MGFA Class II, III, or IV

Patient has a screening and baseline MG-ADL total score ≥5 points with >50% of the score attributed to non-ocular symptoms
Patient is receiving a stable dose of MG therapy before screening that includes AChE inhibitors, steroids, or NSISTs in combination or alone, with the following dose conditions:

– Nonsteroidal immunosuppressive drugs (e.g., azathioprine, methotrexate, cyclosporine, tacrolimus, mycophenolate mofetil, and cyclophosphamide) initiated at least 6 months before screening with no change in dose during the 3 months before screening
– Steroids initiated at least 3 months before screening, with no change in dose during the month before screening
– AChE inhibitors with no change in dose during the 2 weeks before screening

See if your patients can be part of this important study

Additional treatment options are needed for patients with this rare condition. This may be an opportunity for your patients to help advance the research for this disease. If you are interested to see which sites are actively recruiting, pleaseclick for an overview of our international study sites. Info is updated monthly clinicaltrials.gov

The ADAPT SERON study
will be conducted at sites across the United States

Site	Location
Neurology Offices of South Florida	9970 Central Park Blvd N., Ste. 207 Boca Raton, FL 33428
University of South Florida	13330 USF Laurel Drive Tampa, FL 33612
National Neuromuscular Research Institute	4705 Spicewood Springs Road, Ste. 200 Austin, TX 78759
Medsol Clinical Research Center	4161 Tamiami Trl Ste. 120 Port Charlotte, FL 33952
SFM Clinical Research, LLC	1601 Clint Moore Rd., Ste. 120 Boca Raton, FL 33487
University of North Carolina at Chapel Hill	101 Manning Dr Chapel Hill, NC 27514
University of Kansas Medical Center Research Institute, Inc.	4300 Shawnee Mission Pkwy., Ste. 3340 Fairway, KS 66205
Baycare Medical Group	1201 5th Ave N Saint Petersburg, FL 33705
Neurology Associates PA	331 N Maitland Ave Dept A-1 Maitland, FL 32751
Duke Early Phase Clinical Research Unit	40 Duke Medicine Cir Durham, NC 27710
Augusta University Medical Center	1120 15th St Augusta, GA 30912
Northwestern Memorial Hospital	259 E Erie St Fl 19 Chicago, IL 60611
HonorHealth Neurology - Bob Bové Neuroscience Institute	350 W Thomas Rd Phoenix, AZ 85013
Henry Ford Health System	2799 W Grand Blvd Detroit, MI 48202
Erlanger Health System	975 E 3rd St Chattanooga, TN 37403
Healthcare Innovations Institute, LLC	5441 N University Dr Coral Springs, FL 33067

Study Design

Patients will be asked to participate in the study for more than two years. This will include a screening period of up to five weeks, a two-part study structure (Part A (8 weeks) and Part B (up to 2 years)), and finally, an end-of-study visit. In Part A, half of the participants will receive the investigational study drug while the other half will receive a placebo. All participants in Part B of the study will receive the investigational drug.

CLINICALTRIALS.GOV ID: NCT06298552

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*In a research study, the participants may receive investigational study product or may receive an inactive substance, or placebo, depending on the study design. Participants receive study-related care from a doctor/research team for the duration of the study. For studies that offer compensation, reasonable payments will be made for participation. The length of the study may vary.