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If You Have AChR-Antibody Seronegative Generalized Myasthenia Gravis (gMG)
You May Qualify to Enroll in ADAPT SERON, a Clinical Study to Assess an Investigational Study Drug that May Expand gMG Treatment Options
KEY Eligibility Criteria
Who might qualify?
ADAPT SERON is looking to enroll approximately 110 adult participants who have been diagnosed with AChR-antibody seronegative gMG, including MuSK-Ab, LRP4-Ab and gMG patients with no identifiable autoantibodies.
How long does it take?
Participants will be asked to remain in the study for approximately 2 years and 2 months, during which time they will make regular visits to the site for necessary exams and administration of the investigational study drug or placebo. The placebo looks like the investigational study drug but does not contain any active ingredient.
How does ADAPT SERON work?
Participation in ADAPT SERON includes a screening period of up to 5 weeks to verify eligibility. If you are eligible and choose to participate, you will enter part A, which is made up of a 3-week
treatment period and a 5-week follow-up period. Part B follows part A and lasts up to 2 years.
Will I get the investigational study drug?
In part A, half of the participants will be randomly assigned to receive the investigational study drug and half will receive placebo. In part B, all participants are assigned to receive the investigational study drug. Both the investigational study drug and placebo are given through an
intravenous (into a vein in an arm) infusion.
What is the 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.
Where is the study being held?
ADAPT SERON is being run at multiple sites throughout the United States and across the world. www.ClinicalTrials.gov
| 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 |
Where is the study being held?
ADAPT SERON is being run at multiple sites throughout the United States and across the world. www.ClinicalTrials.gov
| 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 |
Why is ADAPT SERON important?
ADAPT SERON is important as it is a study evaluating the safety and efficacy of an investigational study drug for the treatment of adults with AChR-antibody seronegative gMG, including MuSK-Ab, LRP4-Ab and gMG patients with no identifiable autoantibodies.
When is ADAPT SERON happening?
ADAPT SERON is an ongoing study. This study is expected to last 2 years and 2 months.
GOOD TO KNOW
- You may not benefit from being in this study. There is a chance the investigational study drug will reduce your AChRAb- gMG symptoms, but this is not guaranteed. Other people with AChRAb- gMG may be helped in the future by the information collected during this study. The investigational study drug, efgartigimod alfa, is not approved by the FDA for the treatment of patients with AChR-Ab seronegative gMG as efficacy and safety have not been established.
- There is no cost to participate or to receive any treatments or tests required for the study. Participants may also receive reimbursement for study-related travel expenses. Some of the study visits may take place at home by a qualified study nurse.
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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.
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