About this Research Study:
The ADVISE Study is a clinical study to evaluate how an investigational study medication called etrasimod works in people with chronic, moderate-to-severe Atopic Dermatitis (also known as eczema). You may be able to take part in the ADVISE Study if you:
- are 18–70 years of age
- have experienced eczema for at least one year
- have at least 10% of your body affected by eczema
- have had an inadequate response to topical medications
There are additional criteria that are included in the questionnaire on this website and some that are reviewed by the team at the study center at the first visit.
- Learn more about the ADVISE Study. You’ll be speaking with a member of the research staff at the study center to learn more regarding your participation in the ADVISE Study.
- Ask any important questions you may have. These can be any questions you may have about the ADVISE Study or clinical research in general.
- Determine if the ADVISE Study may be right for you. After speaking with the study staff and learning details about the ADVISE Study, the research staff will review some additional study criteria to determine if you are eligible to participate in the ADVISE Study. If you’re eligible, you will be given an opportunity to decide if participation is right for you. If you agree to take part, the center will ask you to review and sign a consent form.
Participants will be required to visit the study center approximately 10 times to meet with the study doctor and staff.
The investigational study medication in the ADVISE Study is etrasimod, a medication taken orally 1 time a day. Etrasimod is being studied to see whether it may reduce symptoms associated with eczema.
The investigational study medication has been previously tested and has been found to be safe and well-tolerated in approximately 281 subjects that have been dosed with the study drug.
Participants might have to stop using their topical corticosteroids or other topical prescription medication for eczema. If you require use of these medications during the study, speak with the study doctor to see what your options are. Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.
- Metals, in particular, nickel
- Cigarette smoke
- Soaps and household cleaners
- Certain fabrics such as wool and polyester
- Antibacterial ointment like neomycin and bacitracin
- Formaldehyde, which is found in household disinfectants, some vaccines, glues and adhesives
- Isothiazolinones an antibacterial that is found in personal care products like baby wipes
- Cocamidopropyl betaine used to thicken shampoos and lotions
- Paraphenylene-diamine, which is used in leather dyes and temporary tattoos, among others
The study centers are located throughout Australia.
There is no cost to you for participating in the study.
Research studies are designed in specific ways to test the investigational drug for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies.
About Research Studies:
A research study (also known as a clinical trial) is a medical study that is designed to answer questions about the safety of potential new drugs and to find out how well they work. Research studies must be performed before a potential new drug can be approved for use in patients.
Research studies are used to test medications before they are sold to the general public. The testing that takes place during the studies provides information regarding the safety and effectiveness of the potential medication.
- Getting actively involved in their own health care
- Having access to potentially new research treatments
- Having access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied
- Helping others by contributing to medical research
Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor’s offices, and/or at hospitals.
Eczema is not contagious! It is caused by a person’s limited ability to repair damage to the skin. External irritants (allergens, heat, sweat, and others) can enter the skin and activate the immune system causing inflammation, redness, and itchiness. There are genetic connections as well, so if your family has a history of eczema, hay fever, or asthma, you are at a higher risk to have eczema.
People with eczema can feel the impact on many different scales. While some will suffer from sleepless nights due to itchiness, others will have depression from isolation, or anxiety from flare-up prevention. Some people with eczema find they miss out on what they consider normal in life such as productivity at work, time with family/friends, exercise, sunshine, freedom to wear certain clothes, hot showers, and more. Eczema can be a burdensome condition.