Study on the Effectiveness and Safety 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 effects of a treatment for Atopic Dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The treatment being tested is called Lebrikizumab, which is a type of medication known as a monoclonal antibody. This medication is given as a solution for injection under the skin.

The purpose of the study is to evaluate how effective and safe Lebrikizumab is for people with moderate-to-severe Atopic Dermatitis. Participants in the study will receive the treatment over a period of 24 weeks. During this time, researchers will monitor changes in the severity of the disease, as well as any signs and symptoms experienced by the participants.

Throughout the study, participants will have regular visits to assess their progress and any improvements in their condition. The study aims to gather information on how well Lebrikizumab works in reducing the symptoms of Atopic Dermatitis and improving the quality of life for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, weight, and medical history related to atopic dermatitis.

The assessment ensures that the condition has been present for at least one year and that previous treatments were inadequate.

2 baseline visit

During the baseline visit, the severity of the condition is evaluated using specific scores such as EASI and IGA.

Participants must have an EASI score of at least 12 and an IGA score of at least 3.

3 treatment initiation

The treatment involves the administration of lebrikizumab, a solution for injection, given subcutaneously.

The treatment period lasts for 24 weeks, during which the effectiveness and safety of the medication are monitored.

4 ongoing assessments

Throughout the study, regular assessments are conducted to monitor progress. These include evaluating changes in EASI and IGA scores.

Participants are required to complete electronic diary entries to track symptoms such as itching and sleep loss.

5 final evaluation

At the end of the 24-week treatment period, a final evaluation is conducted to assess the overall effectiveness of the treatment.

The primary goal is to achieve a significant reduction in the EASI score, with secondary goals including improvements in other related symptoms.

Who Can Join the Study?

Adults and adolescents aged 12 to less than 18 years old, who weigh at least 40 kg, and are suitable for treatments that affect the whole body for Atopic Dermatitis.
The participant must sign a form agreeing to join the study. Adolescents need to sign a separate form or the same form as their parent or guardian, depending on local rules.
Have had Chronic Atopic Dermatitis for at least 1 year before the first screening visit. This is a long-lasting skin condition.
Have an EASI score of 12 or higher at the first visit. EASI is a way to measure the severity of eczema.
Have an IGA score of 3 or higher at the first visit. IGA is a scale from 0 (clear skin) to 4 (severe eczema) to rate the condition.
At least 10% of the body surface area is affected by Atopic Dermatitis at the first visit.
Have a history of not responding well to creams or ointments, or if these treatments are not suitable for medical reasons.
Complete entries in an electronic diary about itching and sleep loss for at least 4 out of 7 days before the first visit.
Be willing and able to attend all clinic visits and follow all study-related procedures and fill out questionnaires.
For women who can have children: agree to not have heterosexual intercourse or use a highly effective birth control method during the treatment and for at least 4 weeks or one menstrual cycle after the last dose of the study medication. This includes methods like hormonal birth control, intrauterine devices, or having a partner who has had a vasectomy.

Who Cannot Join the Study?

Patients with certain other skin conditions that might interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics or other medications.
Patients who have used certain medications that might affect the study results.
Patients with a history of certain serious health conditions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a known allergy to the study medication or its ingredients.
Patients who have not followed the study instructions or requirements in the past.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Hautarztpraxis Dr. Mihaescu	Augsburg	Germany
Studienzentrum Dr. Beate Schwarz	Langenau	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
MVZ Corius Potsdam GmbH	Potsdam	Germany
Dermatologikum Hamburg GmbH	Hamburg	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Bravis Ziekenhuis	Roosendaal	The Netherlands
Universitaetsklinikum Aachen AöR	Aachen	Germany
Dermazentrum München – Zentrale Sendling	Munich	Germany
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Uvkesoowfmoooaqxgwrho Ajykhvtq	Augsburg	Germany
Haatry Sac Evfwoytvi Keujer Ojohiwhgoi Gelq	Oberhausen	Germany
Uuwpwtgkopzhodoaofqdc Dlndrsycoqq Aca	Duesseldorf	Germany
Ekpnfem Uhnsxizylrux Mychrzo Cwwwkog Rqkixmtwl (dmzybnh Mvs	Rotterdam	The Netherlands
Gjdrjp Ubhjgrivow Fewypbcbd	Frankfurt	Germany
Kopwtzkp duf Uqdeabuausia Megwrmci Abc	Munich	Germany
Uriwvdencz Mviadud Cqnslo Hxhqankygllswggeb	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.10.2023
The Netherlands	Not recruiting	01.10.2023

Trial locations

Investigated drugs:

Lebrikizumab

Lebrikizumab is a medication being studied for its effectiveness and safety in treating moderate-to-severe atopic dermatitis, which is a type of eczema. This medication is designed to help reduce the severity of the disease, as well as improve the signs and symptoms associated with it. The study focuses on how well this treatment works over a period of 24 weeks in both adults and adolescents.

Atopic Dermatitis – Atopic Dermatitis is a chronic skin condition characterized by inflamed, itchy, and red patches of skin. It often begins in childhood but can occur at any age. The disease tends to flare periodically and then subside, with symptoms varying in severity. Commonly affected areas include the face, neck, and the insides of the elbows and knees. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. The condition is often associated with other allergic disorders such as asthma and hay fever.

Trial ID:

2023-505558-16-00

Protocol code:

M-17923-33

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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