Atopic Dermatitis (Eczema) ADopt-VA Study
As you know, atopic dermatitis (AD) is a chronic, severe form of eczema that is marked by the appearance of dry, red, and itchy skin. Even with the treatment options that are currently available, many people with AD continue to experience painful and irritating symptoms.
With atopic dermatitis (AD), itching isn’t even the worse part. From the embarrassing red blotches to the painful sores, atopic dermatitis symptoms require the right treatment. If you are between the ages of 18 and 55 years old and have moderate-to-severe AD and topical treatments have not worked well, you may qualify to participate in the ADopt-VA study for an injectable investigational medication. Ask your doctor about the Adopt-VA study (study number: J2T-MC-KGAK/DRM06-AD18) or Call (904) 619-8157 Ext. 2.
Right now, research is underway on an injectable investigational medication for AD. An investigational medication is one that has not been approved by any regulatory agencies. The ADopt-VA study is testing how the investigational medication may impact the effectiveness of certain vaccines, as well as how effective and safe it is in the treatment of adults with moderate-to-severe AD. Study volunteers can help us in this important research. Thank you for considering participation in this study.
Who is eligible?
To be eligible for this study, you must:
• Be between the ages of 18 and 55 years old
• Have had moderate-to-severe AD for at least one year, with a history of inadequate response to topical treatments
• Have not recently received the Tdap or MCV vaccines
This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.
How long will the study last?
You will be in this study for up to approximately 32 weeks, and you will need to come to the study center at least 7 to 11 times over this period.
What to expect
If you qualify for the study and decide to take part, you will be randomly assigned (like the flip of a coin) to receive either the investigational medication or a placebo (which contains no active medication) as a subcutaneous (under the skin) injection every 2 weeks for 16 weeks. You will have a 50% (1 in 2) chance of receiving the investigational medication and a 50% (1 in 2) chance of receiving placebo. The study is blinded, which means that you and the study doctors will not know your treatment assignment.
At 12 weeks, you will receive 2 vaccines: MCV (meningococcal) and Tdap (tetanus, diphtheria, and pertussis). These are common vaccines and they are given as intramuscular (IM) injections.
If you complete the 16-week study treatment, you may be able to continue receiving treatment with the investigational medication in a separate long-term extension study. If you end the study early, or if you choose to not continue to the long-term extension study, you will have a safety follow-up visit approximately 12 weeks after your last study drug injection.
You will have about 11 study visits throughout the study. Some visits will occur at the study clinic and others may be remote (either by telephone, video conference, or home visit). Lab tests, a physical exam, and other assessments and questionnaires will be conducted at study visits. Not all activities will occur at every visit.
What are the costs?
You do not have to pay for the investigational drug, study supplies, study visits, or tests that are part of this clinical research study.