This is a clinical trial designed to evaluate the safety and efficacy of a new medication under development for patients with moderate-to-severe atopic dermatitis (eczema).
All subjects will receive injections of trial medication every other week for up to 52 weeks. For all trial participants, the trial will include up to 31 visits to the trial clinic. Total participation could last up to 72 weeks.
Is this trial right for me?
If you have been diagnosed with a condition known as moderate-to-severe atopic dermatitis you may be eligible to participate in this trial.
Atopic dermatitis (AD) is a chronic inflammatory skin disease. In its severe form, AD is characterised by widespread skin lesions, itch, as well as increased risk of skin infections. AD is associated with a substantial burden that typically includes poor quality of life, sleep disturbance, and reductions in work productivity.
Am I eligible for this trial?
The investigator ensures that potential participants wanting to volunteer are eligible to take part based on the criteria detailed in the clinical trial protocol. This involves reviewing your full medical history, performing a medical examination, obtaining a signed informed consent and obtaining blood sample(s).
You may be eligible to participate in this trial, if you fulfill the following:
- • Age: 18 or older
- • Have diagnosed atopic dermatitis for at least 1 year
- • Atopic dermatitis covering at least 10% of the body
- • Itch due to atopic dermatitis of at least 4 on a scale from 0-10 where 0 is no itch at all and 10 is worst itch imaginable
- • The eczema is not well treated/controlled with creams or ointments containing steroids or these creams/ointments can’t be used due to side effects
- • Must be willing to apply emollients twice daily
- • Must be willing to stop all current treatment for atopic dermatitis (except for use of emollients and/or antihistamines) from 6 till 2 weeks before first injection of trial medication:
- – 6 weeks: tanning beds/ phototherapy/lighttherapy
- – 4 weeks: treatment taken as tablets
- – 2 weeks: creams or ointments containing steroids, Elidel, Protopic or Eucrisa
- • Must be willing to attend the trial/clinic every second week for a minimum of 54 weeks
- • Must be willing to receive 4 injections when the treatment is given to you for the first time and then 2 injections every second week for 50 weeks
What will happen during this trial?
All subjects will initially be screened to determine their eligibility for this trial by a medical doctor. If a subject is eligible, and agrees to participate, there will a screening period, that 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.
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. You should ask the trial staff how long your visits will last. It is important that you are able to attend all trial visits.
You may be using 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 need 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 second 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 (26 treatment visits in total).
Initial treatment period
During the first 16 weeks of treatment, you will receive 1 of the following trial treatments every 2 weeks:
- • Tralokinumab
- • Placebo
Which of these 2 treatments you receive is chosen at random, which means that you will be put into one treatment group by chance (like flipping a coin). A computer will randomly select your treatment. This allows the treatments to be compared more fairly. You will have a 75% chance of receiving tralokinumab, and a 25% chance of receiving placebo. Neither you nor your trial doctor will know which treatment you receive. But your doctor can find out if necessary, for example, if there is a problem.
Maintenance treatment period
From week 16 to week 52 of treatment, you will receive 1 of the following trial treatments:
- • Tralokinumab every 2 weeks
- • Tralokinumab every 4 weeks and placebo every 4 weeks at alternating visits (that is, you will still receive injections every 2 weeks)
- • Placebo every 2 weeks
Which of these 3 treatments you receive is chosen at random. If you received tralokinumab in the initial treatment period, you will have a 40% chance of receiving tralokinumab every 2 weeks, a 40% chance of receiving tralokinumab/placebo every 4 weeks, and a 20% chance of receiving only placebo. If you received placebo in the initial treatment period, you will continue to receive placebo. Neither you nor your trial doctor will know which treatment you receive.
Possible transfer to open-label treatment with tralokinumab
If you do not have a clinical response* after receiving your allocated treatment for the first 16 weeks or more, you will be transferred to open-label** treatment with tralokinumab until week 52, with optional use of topical corticosteroids (steroid cream or ointment).
Likewise – if you experience a worsening of your atopic dermatitis during the maintenance treatment period (from week 16 to week 52), you will be transferred to open-label treatment with tralokinumab.
* A clinical response means that the severity and extent of your atopic dermatitis has been reduced by at least 75%, or that your symptoms are rated ‘clear’ or ‘almost clear’.
** Open-label means that both you and your trial doctor will know which treatment you receive.
During the trial visits, you will be asked to give personal information, such as your date of birth (year and month), gender, race, ethnicity. You will also be asked questions about your general health, your medical history and any medications you take.
The trial doctor will perform a physical examination that includes a whole body inspection of the skin and auscultation of heart, lungs and abdomen; palpation of the abdominal organs and basic neurological status. There will be a number of tests included in case of participation in the trial e.g blood samples, pregnancy tests, electrocardiogram and questionnaires.