A Clinical Trial to Learn More About an Experimental Oral Treatment for Moderate to Severe Atopic Dermatitis

NCT ID: NCT05117060

Dermatology beyond the skin

About the Condition/Disease Overview:

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:

  • redness and inflammation in the skin
  • thickened, cracked, scaly, dry skin
  • raw, sensitive, swollen skin from scratching

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).

About the Trial:

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.

Trial Details

The main goals of this trial are:

  • To learn whether the study drug helps reduce the extent and severity of AD
  • To learn more about the safety and tolerability of the study drug, including any side effects the participants may have during treatment

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.

Phase

Phase 2

Estimated Enrollment

224 participants

Eligibility Criteria

Inclusion Criteria

Participants must

  • Be at least 18 years old
  • Have AD that covers at least 5% of their body
  • Have moderate to severe AD
  • Have had AD for at least 1 year
  • Have tried topical AD treatments, such as steroids, in the last 6 months without success
    • “Success” is defined as the disappearance of AD symptoms or only mild AD symptoms after using a topical treatment daily for at least 4 weeks (or the maximum duration prescribed by your doctor)

Exclusion Criteria

Participants must not

  • Have tried 3 or more systemic treatments (such as pills or injections that travel through the bloodstream) for their AD
  • Have HIV or active tuberculosis
  • Have a history of certain heart problems (trial doctors will evaluate this before you join the trial)
  • Have kidney or liver problems
  • Have a recent history (in the last 12 months) of chronic alcohol or drug abuse
  • Be a participant in another clinical trial to evaluate an experimental treatment
  • Have another skin disease or any condition that would make it unsafe for them to participate, make it difficult for doctors to evaluate the effects of treatment, or affect the participant’s ability to participate fully in the clinical trial (trial doctors will evaluate this before you join the trial)
  • Be pregnant or breastfeeding
See if you are eligible

What Will Happen in this Trial

If you are interested in joining this trial, you will need to visit a trial site.

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.

This trial is only open to people with moderate or severe AD who have not been helped recently (within the last 6 months) by topical treatments for AD.

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.

Throughout the trial, the participants will keep track of the severity of their AD symptoms twice a day by responding to a few questions in an electronic diary.

If you decide to join this trial, you will be randomly assigned to receive either the study drug or a placebo.

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.

In total, participants will be asked to visit the trial site 13 times over a period of 22 weeks.

During trial site visits:

  • Trial doctors will collect blood and urine samples, evaluate the extent and severity of each participant’s AD, check on the participants’ overall health, and ask participants about how they are feeling, any new medications they are taking, and any new or worsening medical issues they might be having.
  • Participants will fill out questionnaires that ask about their AD and its impact on different aspects of their lives.

Where You Can Join

This trial is being conducted in sites located in Europe and the United States, with the goal of enrolling 224 patients worldwide.

Location
International Clinical Research - Tennessee LLC
Status
Recruiting
Location
Care Access Research, Alexandria
Status
Not Yet Recruiting
Location
Care Access Research, Hoboken
Status
Not Yet Recruiting
Location
Dermatology Research Associates
Status
Recruiting
Location
Skin & Cancer Foundation Australia
Status
Recruiting
Location
University of Cincinnati
Status
Not Yet Recruiting
Location
St George Dermatology and Skin Cancer Centre
Status
Recruiting
Location
Skin Health Institute Inc.
Status
Recruiting
Location
Holdsworth House Medical Practice
Status
Recruiting
Location
Burswood Dermatology
Status
Not Yet Recruiting
Location
Monash Medical Centre
Status
Recruiting
Location
North Texas Center for Clinical Research
Status
Not Yet Recruiting
Location
Therapeutics Clinical Research
Status
Recruiting
See if you are eligible

Frequently Asked Questions (FAQs)