A Clinical Trial to Learn More About an Experimental Oral Treatment for Moderate to Severe Atopic Dermatitis
NCT ID: NCT05117060
NCT ID: NCT05117060
Atopic dermatitis (AD) is a common type of eczema that affects up to 10% of adults. It is a chronic skin disease with intense itching, characterized by persistent inflammation and defects of the skin barrier.
AD is considered a genetically determined skin disease. The condition usually first appears during early childhood and may persist into teenage years and adulthood.
The symptoms of AD include:
Some people experience AD “flare-ups” (times when symptoms are worse) followed by times when symptoms are absent or very mild, while others experience symptoms almost constantly.
AD has a significant, negative impact on a person’s well-being. The itching and inflammation can affect a person’s sleep quality as well as their overall quality of life.
Researchers are looking for better long-term treatments for AD that will help relieve moderate to severe symptoms with fewer side effects.
The investigational treatment being studied in this trial is an oral medication called LEO 152020 (study drug).
This is a “Phase 2” trial. Drugs that enter Phase 2 trials have already been studied in other clinical trials. Researchers have already gathered information about the safety of the drug, usually in small numbers of participants. In a Phase 2 trial, the drug is studied in a larger group.
Phase 2 trials help researchers learn more about the safety of a drug, including possible side effects people might have when they take it. They also help researchers begin to learn how well a drug works as a treatment for a specific disease or condition, and which dose(s) of the drug should be studied further.
This trial will include adults with moderate to severe AD who have had AD for at least 1 year and have not been helped by topical treatments (creams or ointments applied directly to the skin). People who live in Europe, North America, Japan, or Australia can join this trial if they meet the trial eligibility criteria and have reasonable access to a clinical trial site. Leo Pharma (the trial sponsor) may be able to help cover travel costs of participants.
The main goals of this trial are:
Researchers also hope to learn more about the effects of AD on the participants’ well-being, including their sleep quality, work productivity, and overall quality of life, and whether treatment with the study drug improves these outcomes for people with moderate to severe AD.
A trial doctor will explain the trial to you. If you agree to join, the doctors and other site staff will give you an examination and ask you questions about your AD and your medical history to make sure you are eligible.
In addition, people with certain medical conditions might not be eligible if a trial doctor thinks the person’s health issues might make it unsafe for them to participate or might make it difficult to evaluate the effects of treatment.
It may take up to 5 weeks and 2 visits to a trial site to gather all of the information needed to determine whether you are eligible to join the trial.
About 7 out of every 10 participants will receive the study drug, and 3 out of 10 will receive the placebo (What is a placebo?). During treatment, none of the participants or any of the trial site staff will know who is receiving the study drug and who is receiving a placebo. Participants will take their assigned study treatment twice a day for 16 weeks (about 4 months). They will visit the trial site once a week or once every 2 weeks to check in with the trial doctors and get a refill of their trial medication.
At the end of the trial, the participants will have 1 more visit to the trial site about a week after they take the last dose of their assigned trial treatment.
During trial site visits:
This trial is being conducted in sites located in Europe and the United States, with the goal of enrolling 224 patients worldwide.