This information is intended for
U.S. residents only.
Contact: clinicaltrials@argenx.com
This information is intended
for U.S. residents only.
For More Information,
Contact: clinicaltrials@argenx.com
Contact: clinicaltrials@argenx.com
A Clinical Study for Adults with Ocular Myasthenia Gravis
You may qualify to enroll in ADAPT OCULUS, a clinical study to assess an investigational study drug.
For More Information, Contact: clinicaltrials@argenx.com
ADAPT OCULUS Q&A
Who might qualify?
ADAPT OCULUS is looking to enroll about 124 adult participants aged 18 years or older diagnosed with ocular myasthenia gravis and experiencing eye symptoms such as double vision and drooping eyelids.
How long does it take?
Participants will be asked to stay in the study for about 2 years and 3 months, during which time they will visit the site regularly 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
OCULUS work?
Participation in the ADAPT OCULUS study includes a screening period of up to 5 weeks to check if you are suitable for the study. If you are eligible and choose to participate, you will enter part A, which lasts 7 weeks. Part A is followed by part B which 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 while the other half will receive a placebo injection. In part B, all participants are assigned to receive the investigational study drug. Both the investigational study drug and placebo are given through a subcutaneous injection (meaning under the skin) using a pre-filled syringe.
How long does it take?
Efgartigimod PH20 SC is being evaluated for autoimmune diseases mediated by pathogenic IgG autoantibodies, including ocular myasthenia gravis. The investigational study drug, efgartigimod PH20 SC, is not approved by the FDA for the treatment of patients with ocular myasthenia gravis as efficacy and safety have not been established.
Why is ADAPT
OCULUS important?
There is an unmet medical need for treatment options for patients with this condition. ADAPT OCULUS is important as it is a study evaluating the safety and efficacy of an investigational study drug for the treatment of ocular myasthenia gravis in adults.
When is ADAPT OCULUS happening?
Right now. ADAPT OCULUS is an ongoing study.
See if you are eligible for ADAPT OCULUS
For More Information, Contact: clinicaltrials@argenx.com
Where is the study being held?
ADAPT OCULUS is being run at multiple sites throughout 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 |
For More Information talk to your doctor, Visit clinicaltrials@argenx.com
GOOD TO KNOW
- You may not benefit from being in this study. There is a chance the investigational study drug will reduce your ocular myasthenia gravis symptoms, but this is not guaranteed. The information collected during this study may help in the research of ocular myasthenia gravis. The investigational study drug, efgartigimod PH20 SC, is not approved by the FDA for the treatment of patients with ocular myasthenia gravis 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.
©2024 Acurian, Inc. All rights reserved.
*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.
©2024 Acurian, Inc. All rights reserved.
