PatienTrials

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This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A phase 2a, randomized, double-blind, placebo-controlled, multi-site, proof of concept trial to evaluate the efficacy and safety of LEO 138559 in adult subjects with moderate to severe atopic dermatitis (AD).

This is a clinical trial in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the trial is to test an investigational medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient.

Trial ID: NCT04922021 [LP0145-1376]

Trial Details

The trial will last up to 36 weeks for each participant. The trial will include a study treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without study treatment with the main purpose of continuing safety evaluations. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms and quality of life.

Estimated Enrollment

52 Participants

Phase

Eligibility Criteria

Participants must:

Be between 18 to 64 years old (both included).
Have been diagnosed with atopic dermatitis (AD) more than 1 year ago.
Have atopic dermatitis (eczema) on at least 10% of your body.
Have had an inadequate response to treatment with topical medication within 6 months or for whom topical treatments are otherwise medically inadvisable.

Participants must not:

Have a hepatitis B or C infection.
Have a human immunodeficiency virus (HIV) infection.
Have tuberculosis.
Have diabetes
Be pregnant or breast feeding.

What to Expect

Potential participants will be screened to determine eligibility and qualified participants will be seen by a doctor and receive all study-related exams, care and medications at no cost. In addition, compensation for trial-related travel may be provided if you qualify to participate.

The screening period is when the study doctor will evaluate your disease and run some blood tests to see if you qualify.
You will be randomly assigned to receive either the investigational medicine or a placebo (which contains no medication)
Blood draw and urinalysis at some of the visits during the first 16-weeks.

You will need to travel to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

Will I be paid for taking part in this clinical trial?

You will be paid to cover your reasonable travel expenses during the trial. The trial doctor or trial staff can tell you more about how you will be reimbursed.

Will it cost me anything to take part?

There is no cost to you, your private medical insurance (if you have one), or the public health insurance plan for the trial procedures. LEO Pharma will provide the trial medicine to you for free during the trial.

What is the medicine that is being tested?

LEO 138559 is an investigational medicine, which inhibits specific processes in the body’s own response to diseases like atopic dermatitis. The medicine is not currently approved for use outside of clinical trials. In this trial, LEO 138559 will be compared with placebo, which does not contain the medically active ingredient.

Who is organizing and funding the research?

LEO 138559 is an investigational medicine that is being developed and tested by the pharmaceutical company LEO Pharma for atopic dermatitis.

LEO Pharma is organizing and funding the trial.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What will happen if I take part?

The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a study treatment period (16 weeks), and a safety follow up period (16 weeks). Your trial doctor or the trial staff will tell you when to come in for your trial visits and how long your visits will last. It is important that you come to all visits.

What will happen if I want to leave the trial?

You can leave the trial any time. If you no longer want to be treated with the trial medicine, you can still stay in the trial and complete the final assessments. If you want to leave the trial early, the trial doctor, or trial staff may ask you to complete some procedures and tests. This is to ensure your safety when you stop taking the trial medicine and to collect more information relevant for the trial. You can refuse to do this.

Which personal trial data will be collected?

Personal trial data about you will be collected by the trial staff during your participation in the trial, including:

Medical history and diagnosis.
Previous and current medicines used.
Date of birth, gender, race, ethnicity, height, and body weight.
Skin type.
Clinical evaluation of the treatment with trial medicine.
Blood and urine samples and data generated from these samples.
Tape stripping samples and data generated from these samples.
Skin swab samples and data generated from these samples.
Side effects.

Who has access to your medical records?

Your trial doctor will look at your past medical records for health information such as medical history and recent treatments you may have received. Your medical records may be inspected and monitored by authorized representatives of LEO Pharma, and possibly also by Institutional Review Boards, Independent Ethics Committees, and government regulatory authorities. The purpose of such inspections and monitoring visits is to check that the information recorded on the trial forms is the same as in the medical records, and to ensure that the trial is done correctly. The trial doctor will correct any errors found during inspections. As part of this trial, the trial doctor will record the results of your trial-related assessments in your medical records. By signing the consent form, you allow this access to your medical records.

What will happen to the results of the trial?

To make clinical trials more transparent, results from this trial will be posted on the LEO Pharma website, www.leopharmatrials.com.

You can find the trial results on LEO Pharma’s website about one year after the entire trial has finished. There is a link to the website on the trial card you will receive. There will be both a technical summary of the trial and a summary written in plain language.

The results may also become available on global and national data registries, for instance www.clinicaltrials.gov and www.clinicaltrialsregister.eu. Furthermore, the results may be published in a medical journal. Regardless of where the results are published, LEO Pharma will protect your identity using methods that comply with the laws on data protection. No information will be given from which you could be directly identified, but the published data may include age, gender, medical history, and nationality.