Tralokinumab monotherapy for moderate to severe atopic dermatitis

Description

The purpose of the trial is to test if the trial drug, tralokinumab, is better than placebo or ‘dummy treatment’ at treating moderate to severe atopic dermatitis. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis, itch and several other symptoms, as well as general health status and quality of life.

Tralokinumab is an investigational drug that is being developed and tested by LEO Pharma A/S (hereafter referred to as LEO or sponsor) to treat moderate to severe atopic dermatitis. An investigational drug is a drug that is not currently approved by the U.S. Food and Drug Administration (FDA) for use outside trials like this one. Tralokinumab is an antibody, a type of a biological drug, which binds to a human protein called IL-13. IL-13 is involved in the body’s immune responses to fight diseases. By binding to IL-13, tralokinumab may improve or clear the symptoms of atopic dermatitis. Tralokinumab has already been tested in more than 2000 subjects in a total of 17 clinical trials. These trials have included subjects with atopic dermatitis, subjects with other chronic and inflammatory diseases, as well as healthy subjects. In this trial, tralokinumab will be compared with placebo, which is a ‘dummy treatment’ similar to tralokinumab except that it does not have any drug or active ingredients in it. Together, the tralokinumab and the placebo will be referred to as trial medication or trial treatment.

The trial will last up to 72 weeks, and there will be up to 31 visits. The trial visits will typically be every 2 weeks. Your trial doctor will tell you when to come in for your trial visits.

The first part of the trial is called a screening period and will last for a minimum of 2 weeks and a maximum of 6 weeks. During screening, the trial doctor will check your medical history and find out if you are eligible to participate in the trial. You will be asked to complete questionnaires and your vital signs will be measured. A physical exam and an ECG (measures the electrical activity of your heart) will be performed, Female subjects will have a pregnancy test performed, and blood and urine samples will be collected, including a test for HIV and hepatitis B and C. Positive HIV and Hepatitis test results may be reportable to local health authorities according to local laws. You may be using some treatments at the moment that need to be stopped before you can participate in the trial. This may include treatments for atopic dermatitis. Your trial doctor will tell you which of your treatments, if any, that needs to be stopped. If you are eligible to participate in the trial and would still like to participate, trial staff will give you the trial medication by injection every other week. The injection will be just under the skin on your upper arm, thigh, or stomach. At the first treatment visit, you will receive 4 identical injections, each measuring 1 mL (approximately 1/5 of a teaspoon). You will then receive 2 identical injections at each visit, every 2 weeks for 52 weeks.

Participation will be approximately 22 weeks.

You may receive up to $1684.00 if you complete the entire study, as a compensation for your time and travel.

Details