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 moderate-to-severe 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.
The ADVISE Study will involve taking the investigational study medication (etrasimod or placebo), visiting the study center, and completing study procedures. You may be asked to visit the study center approximately 10 times.
This initial appointment is an opportunity for you to:
- 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.
If eligible, participation can last approximately 3 to 4 months, which includes approximately 10 visits to the study center. Subsequently, some participants may be eligible to join an Open-Label Extension (OLE) study for a little over a year where all participants receive the investigational medication. The study doctor and staff can answer any questions you have about the studies.
An open-label extension (OLE) study is a type of study in which all participants are given the investigational medication, meaning no placebo (inactive pill) is being tested. Both the researchers and participants know that the participant is receiving the investigational medication. The objective of the OLE study is to assess the safety of the long-term use of the investigational medication. Participants are typically informed about an OLE study at the time they are recruited into the main study.
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 moderate-to-severe 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.
If you qualify for the ADVISE Study, you will have a 2-in-3 chance of receiving etrasimod (investigational medication) and a 1-in-3 chance of receiving placebo (inactive treatment) during the first 12 weeks. After which, eligible subjects who qualify for the second phase of the study will receive estrasimod (investigational medication).
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.
There are everyday products and even natural substances that can cause your skin to burn and itch, or become dry and red.
These could be products that you use on your body or in your home — hand and dish soap, laundry detergent, shampoo, bubble bath and body wash, or surface cleaners and disinfectants. Even some natural liquids, like the juice from fresh fruit, vegetables, or meats, can irritate your skin when you touch them.
Some common eczema irritants include:
- 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
Emollients are non-cosmetic moisturizers which come in the form of creams, ointments, lotions and gels. Emollients can help skin to feel more comfortable and less itchy. They keep the skin moist and flexible, helping to prevent cracks. During this study, emollients will need to be used.
The study centers are located throughout North America.
There is no cost to you or your insurance provider for participating in the study.
No, health insurance is not needed in order to participate.
Research studies are designed in specific ways to test the investigational medication 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.
One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial’s purpose, who is eligible to participate, locations, and phone numbers to call for more information.
For those who are eligible, taking part in research studies offers several benefits:
- 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
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.
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.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the study. Participants must sign an “informed consent” form before joining the study, indicating they understand that the study is research, and that they can leave the research study at any time. This informed consent helps ensure that a prospective research study participant understands what’s involved.
All eczema causes various levels of itching, and redness. Some types of eczema cause flaky, or crusty skin while others cause tiny blisters with watery liquid inside. Eczema is a chronic (long-term) inflammatory skin disease with repeated flare-ups of red, raised or swollen bumps or sores that are itchy and can leak clear liquid.
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.