A Study to Learn How Well the Study Treatment Zabedosertib (BAY1834845) Works and How Safe it is Compared to Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

NCT ID: NCT05656911

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2024-01-31

Brief Summary

Researchers are looking for a better way to treat atopic dermatitis (AD), an often long-lasting inflammation of the skin. Atopic dermatitis, also called eczema, is causing patches of skin to become swollen, red, cracked, and itchy.

The immune system helps protect the body from diseases. But sometimes the immune system can be too sensitive and overreact. This may then lead to allergies but also to skin conditions like atopic dermatitis.

The study treatment zabedosertib (BAY1834845) is currently under development for the treatment of atopic dermatitis and other inflammatory diseases. It works by reducing the activity of a protein called IRAK4. IRAK4 promotes the production and activation of a series of proteins that trigger inflammation reactions in the immune cells. By reducing the activity of IRAK4, the inflammation reactions are expected to be reduced.

The main purpose of the study is to learn how well zabedosertib works compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. How well it works means to find out the efficacy of zabedosertib. To answer this, the researchers will compare how many participants had 75% EASI score reduction after 12 weeks treatment between participants treated with zabedosertib and those treated with placebo. EASI represents Eczema Area and Severity Index (EASI). It is a tool for measuring the amount and severity of atopic dermatitis that a patient has on his or her body. The score ranges from 0-72, with 0 meaning clear skin and 72 meaning severe atopic dermatitis. In addition, the itch of the study participants and other tools for measuring the severity of atopic dermatitis will be assessed.

The secondary purpose of the study is to learn how safe it is compared to placebo. To know this, study team will compare how many participants having adverse events after taking study treatment between participants treated with zabedosertib and those treated with placebo.

In the study, participants will be randomly (by chance) assigned to receive zabedosertib or placebo. The participants from both treatment groups will take zabedosertib or placebo for up to 12 weeks.

The study consists of an up to 28-day screening period (Visits 1 and 2), a 12-week treatment period consisting of 5 visits (Visits 3 to 7), and a 4-week follow-up visits (Visits 8). Thus, the total study duration per participant will be 17 to 20 weeks (approximately 140 days).

During the study, the study team will:

• take blood and urine samples
• take skin samples (not obligatory for all patients)
• check the participants' disease area for assessment
• provide participants device to record their disease status and to take pictures on their disease areas
• have participants complete self-reported questionnaires
• do physical examinations
• examine heart health using ECG
• check vital signs
• ask the participants questions about how they are feeling and what events they are having.

An adverse event is any problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

At 28 days after the participants take their last treatment, the study team will check if participants have any events that might be related to the study treatment. This will be the last visit for the study.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Zabedosertib

Participants will receive zabedosertib for up to 12 weeks (84 days).

Group Type: EXPERIMENTAL

Zabedosertib (BAY1834845)

Intervention Type: DRUG

Oral administration, two times a day

Matching placebo to zabedosertib

Participants will receive placebo to zabedosertib for up to 12 weeks (84 days).

Group Type: PLACEBO_COMPARATOR

Placebo to zabedosertib (BAY1834845)

Intervention Type: DRUG

Oral administration, two times a day

Interventions

Zabedosertib (BAY1834845)

Oral administration, two times a day

Intervention Type: DRUG

Placebo to zabedosertib (BAY1834845)

Oral administration, two times a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 to 65 years of age inclusive, at the time of signing the informed consent.
• Diagnosis of atopic dermatitis (AD) for ≥ 1 year at the screening visit.
• Moderate-to-severe AD at randomization visit as defined by

• Eczema Area and Severity Index (EASI) score ≥ 16,
• Body surface area (BSA) affected by AD ≥ 10%,
• Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3, and
• Peak Pruritus 0-10 numerical rating scale (NRS) ≥ 4 (average score of the daily scores of the 7 days before randomization, with ≥ 4 scores required).
• Documented history (within 6 months prior to the first screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or if TCS are medically not advisable (e.g., due to important side effects or safety risks).
• Stable amount of emollient applied to skin over the whole body twice daily for at least the 7 consecutive days before the randomization visit
• Body mass index (BMI) within the range of 18.5 to 35.0 kg/m^2 (inclusive) at screening (Visit 1) and randomization visits.
• Women of childbearing potential and male subjects able to father children must agree to use adequate contraception when sexually active.

Exclusion Criteria

• History of any major surgery within 8 weeks prior to screening or scheduled (elective) surgery, planned hospitalization and/or planned dental treatment during the study that could constitute a risk when participating in a study.
• Severe invasive infections in medical history and/or active clinically significant viral, bacterial, fungal, or parasitic infection (systemic or severe skin infection) ≤ 3 months prior to the randomization visit.
• A presence of uncontrolled condition including cardiovascular, respiratory, hepatic renal, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product, study conduct or could interfere with the interpretation of data.
• Known immunodeficiency disorder or immunocompromised state or, in the opinion of the investigator, unacceptable risk for participating in the study.
• Use of topical treatments for AD within 7 days before the randomization visit.
• Systemic immunosuppressive/ immunomodulating therapy or phototherapy within 4 weeks before the randomization visit.
• Therapy with biologic drugs within 5 half-lives of the biologic drug
• Known hypersensitivity to the study drug

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NorthShore University HealthSystem | Skokie Hospital - Dermatology Department

Skokie, Illinois, United States

Beth Israel Deaconess Medical Center - Dermatology

Boston, Massachusetts, United States

University of Cincinnati College of Medicine - Dermatology

Cincinnati, Ohio, United States

Arlington Research Center, Inc. | Arlington, TX

Arlington, Texas, United States

Dermamedica s.r.o.

Náchod, Královéhradecký kraj, Czechia

Clintrial s.r.o.

Prague, , Czechia

Praglandia

Prague, , Czechia

Clinique Bezannes

Bezannes, , France

Centre Hospitalier Universitaire Nice | L'Archet Hospital - Dermatology Department

Nice, , France

Hôpital Saint Louis

Paris, , France

Hautarztpraxis Prof. Dr. med. Christian Termeer

Stuttgart, Baden-Wurttemberg, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

A.O.U. di Ferrara

Ferrara, Emilia-Romagna, Italy

Humanitas Research Hospital | Cardio Center - Clinical, Interventional Cardiology and Coronary Care

Milan, Lombardy, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

Catania, Sicily, Italy

Dermal NZOZ Sp Osrodek Dermatologiczny Bialystok-Podlasie

Bialystok, , Poland

Centrum Nowoczesnych Terapii Dobry Lekarz

Krakow, , Poland

Santa Sp. z o.o.

Lodz, , Poland

Royalderm Agnieszka Nawrocka

Warsaw, , Poland

Whipps Cross University Hospital - Clinical Research Unit

Leytonstone, London, United Kingdom

Medicines Evaluation Unit

Wythenshawe, Manchester, United Kingdom

Countries

United States; Czechia; France; Germany; Italy; Poland; United Kingdom

References

Jodl SJ, Worm M, Friedrichs F, Heinzel-Pleines U, Wagenfeld A, Feldmuller M, Klein S, Zhang R, Shakery K, Holzmann RD, Rohde B, Perera V. Efficacy and Safety of Zabedosertib, an Interleukin-1 Receptor-Associated Kinase 4 Inhibitor, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II Randomized Study. Dermatol Ther (Heidelb). 2025 Sep 4. doi: 10.1007/s13555-025-01505-z. Online ahead of print.

Reference Type: DERIVED

PMID: 40906353 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.bayer.com/

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Other Identifiers

2022-000520-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

22158

Identifier Type: -

Identifier Source: org_study_id