What is a clinical research study?
In a clinical research study, doctors evaluate how a particular medication works in the treatment of a disease or condition. Before any new medication can be approved, a clinical research study must be conducted. Without them, we would have no new treatment options.
Atopic Dermatitis (AD) is a common, chronic, non-infectious skin condition. The main symptoms of this inflammatory disease is a very itchy rash, which leads to scratching, and more redness, swelling, cracking, leaking clear fluid, crusting, and scaling.
In many cases AD gets better as the years go by, and it may go away for a while or disappear altogether. AD flare-ups (and getting worse at times) can really affect quality of life. People with AD tend to have an over-reactive immune system that when triggered by a substance outside or inside the body, responds by producing inflammation. It is this inflammation that causes the red, itchy and painful skin symptoms
What will the FB825CLRS01 study involve?
Participants joining the study will need to visit the study center several times during a period of up to 28 weeks which include 9 study visits to the study site.
The study will be conducted in 3 Parts:
- Screening part (around 4 weeks)
- Study Treatment period (around 12 weeks). You will receive a one-hour intravenous infusion with FB825 at Visit 4 (Day 29), Visit 5 (Day 57) and Visit 6 (Day 85).
- Follow-up period (around 12 weeks).
Note: You will receive either FB825 or placebo. Neither you nor the study doctor will know which study treatment group you have been randomized to.
At each visit, the study doctor will ask questions about your symptoms. Overall health will be monitored throughout the study using:
- Physical examinations
- Blood pressure , weight, heart and breath rate , and body temperature
- Blood and urine tests
- Dermatologic evaluations include questionnaires to confirm the atopic dermatitis diagnosis and, determine how severe symptoms of atopic dermatitis are.
For more information…
If you would like to know more about the FB825CLRS01 Study, please speak with your family doctor or dermatologist, who may refer you to the local study team using the contact information below. They will be happy to give you more information about the study and answer any of your questions.
The FB825CLRS01 study for adults with Atopic Dermatitis.
Who can participate in the FB825CLRS01 Study?
You may be eligible to participate in the study if you are:
- An adult between 18 and 70 years of age
- Diagnosed with AD
There will be about 90 participants with atopic dermatitis in this study at about 10 sites within the United States.
You may leave the study at any time. You will receive some compensation for travel and study visits that you complete.
The cost of all study-related health assessments and study medication in the study will be covered.