Study on the Long-term Safety and Effectiveness of Lebrikizumab for Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called Lebrikizumab for individuals with Atopic Dermatitis, which is a condition that causes the skin to become red, itchy, and inflamed. The study involves adults and adolescents who have moderate-to-severe forms of this skin condition. Lebrikizumab is a type of medication known as a monoclonal antibody, which is given as a solution for injection under the skin. The purpose of the study is to observe how well patients tolerate this treatment over a period of two years.

Participants in the study will receive Lebrikizumab every four weeks. The study will monitor any side effects that may occur and how often patients need to stop the treatment due to these side effects. The study will also look at improvements in the severity of the skin condition, such as reductions in redness, itching, and the overall area of skin affected. The study aims to provide valuable information on the long-term use of Lebrikizumab for managing Atopic Dermatitis.

Throughout the study, participants will have regular visits to assess their skin condition and overall health. The study will track changes in the skin’s appearance and the level of discomfort experienced by participants. This information will help determine the effectiveness of Lebrikizumab in providing relief from the symptoms of Atopic Dermatitis over an extended period. The study is designed to ensure that participants receive the best possible care while contributing to a better understanding of this treatment option.

1 joining the study

Upon joining the study, you will be asked to provide written consent. This means you agree to participate and understand the purpose and risks involved.

You will need to confirm that you have completed treatment with lebrikizumab in a previous study and attended the last assessment visit.

2 initial assessment

An initial assessment will be conducted to evaluate your current health status and ensure you meet the study requirements.

This assessment will include a review of your medical history and a physical examination.

3 medication administration

You will receive lebrikizumab, which is a solution for injection. The medication will be administered under the skin, a method known as subcutaneous use.

The dosage is 250 mg every four weeks (Q4W). This will continue for the duration of the study, which is up to two years.

4 regular follow-up visits

You will attend regular follow-up visits to monitor your response to the medication and any side effects.

During these visits, various assessments will be conducted, including skin evaluations and questionnaires about your symptoms and quality of life.

5 end of study

At the end of the study, a final assessment will be conducted to evaluate the long-term effects of the treatment.

You will be asked to provide feedback on your experience and any changes in your condition.

Who Can Join the Study?

Patients who have completed treatment with lebrikizumab in a previous study called ADjoin and attended their last assessment visit at Week 100 in that study.
For Women of Childbearing Potential (WOCBP): Must agree to either remain abstinent (avoid heterosexual intercourse) or use a highly effective birth control method during the treatment period and for at least 4 weeks after the last dose of lebrikizumab.
- Highly effective birth control methods include:
  - Combined hormonal contraception (oral, intravaginal, transdermal) that prevents ovulation.
  - Progestogen-only hormonal contraception (oral, injectable, implantable) that prevents ovulation.
  - Intrauterine device (IUD).
  - Intrauterine hormone-releasing system.
  - Bilateral tubal occlusion or ligation (surgical procedures to block or tie the fallopian tubes).
  - Partner with a vasectomy (surgical procedure for male sterilization).
  - Sexual abstinence, if it means avoiding heterosexual intercourse during the entire risk period associated with the study treatments.
- Note: Periodic abstinence methods (like calendar or ovulation methods) and withdrawal are not acceptable.
Ability to understand the purpose and risks of the trial, willingness and ability to follow the study rules, and provide written informed consent or assent according to guidelines.
Capable of giving signed informed consent or assent, which includes agreeing to the requirements and restrictions listed in the informed consent form and the study protocol.

Who Cannot Join the Study?

Patients who do not have Atopic Dermatitis cannot participate. Atopic Dermatitis is a skin condition that causes itchy and inflamed skin.
Patients who are not within the age range specified for the study cannot participate. The study includes adults and adolescents.
Patients who have certain other medical conditions that might interfere with the study cannot participate. These conditions will be assessed by the study team.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had a recent infection or are currently experiencing an infection cannot participate.
Patients who have a history of severe allergic reactions to medications cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have used certain medications recently that might interfere with the study cannot participate. The study team will provide details on which medications are not allowed.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Gyncentrum Sp. z o.o.	Katowice	Poland
Evimed Sp. z o.o.	Warsaw	Poland
Technische Universitaet Dresden	Dresden	Germany
Hautarztpraxis Dr. Mihaescu	Augsburg	Germany
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow	Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o.	Iwonicz-Zdroj	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Clinical Research Group Sp. z o.o.	Warsaw	Poland
Rosenpark Research GmbH	Darmstadt	Germany
Dermatologikum Hamburg GmbH	Hamburg	Germany
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
ISA Interdisciplinary Study Association GmbH	Berlin	Germany
Clinica Vitae Sp. z o.o.	Gdansk	Poland
Klinische Forschung Osnabrueck	Osnabrück	Germany
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Pjssewwbo Iigscusc Mveppqca Mlzmcygpnquj Syfzs Wlvcwcrynnau I Asicqteorvkdl	Warsaw	Poland
Dlblawkamd Shh z ouch	Wroclaw	Poland
Lbnomzd Sgua Botkj Bvnonzfxisrqm Bewpyhh Sibwvxjaotnn	Ossy	Poland
Gnaliv Uwhszputlv Fooqsxxvf	Frankfurt	Germany
Pyrayae Sva z oirz	Katowice	Poland
Tultdjclcft ujs Syddbljvrkj Bifxspdt Gnlo	Bad Bentheim	Germany
Cmvzjsi Azwgzcjfozx Saq z oqgp	Poznan	Poland
Gcbgyoe Dtnlaemtwcrccqu Bkcmm Kbdyzjj	Kielce	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	02.05.2023
Poland	Not recruiting	02.05.2023

Trial locations

Investigated drugs:

Lebrikizumab

Lebrikizumab is a medication being studied for its potential to help people with moderate-to-severe atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. This medication works by targeting a specific protein in the body that is involved in causing inflammation. By blocking this protein, lebrikizumab may help reduce the symptoms of atopic dermatitis, such as itching and skin irritation. The study aims to see how safe and effective lebrikizumab is when used over a long period, specifically two years, to ensure it can be a reliable treatment option for patients.

Atopic Dermatitis – Atopic Dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. The skin’s barrier function is compromised, leading to increased sensitivity and susceptibility to infections. Over time, repeated scratching and inflammation can cause the skin to thicken and become leathery. Environmental factors, allergens, and stress can trigger or exacerbate symptoms.

Trial ID:

2022-502575-30-00

Protocol code:

M-17923-32

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-term Safety and Effectiveness of Lebrikizumab for Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?