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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
NCT05656911 · View on ClinicalTrials.gov ↗
Study 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, part
Conditions Studied
Interventions
- DRUG Zabedosertib (BAY1834845)
- DRUG Placebo to zabedosertib (BAY1834845)
Study Locations (20)
Other
- Clintrial s.r.o. — Prague
- Praglandia — Prague
- Clinique Bezannes — Bezannes
- Centre Hospitalier Universitaire Nice | L'Archet Hospital - Dermatology Department — Nice
- Hôpital Saint Louis — Paris
- Charité - Universitätsmedizin Berlin — Berlin
- Dermal NZOZ Sp Osrodek Dermatologiczny Bialystok-Podlasie — Bialystok
- Centrum Nowoczesnych Terapii Dobry Lekarz — Krakow
- Santa Sp. z o.o. — Lodz
- Royalderm Agnieszka Nawrocka — Warsaw
Lombardy
- Humanitas Research Hospital | Cardio Center - Clinical, Interventional Cardiology and Coronary Care — Milan
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
Illinois
- NorthShore University HealthSystem | Skokie Hospital - Dermatology Department — Skokie
Massachusetts
- Beth Israel Deaconess Medical Center - Dermatology — Boston
Ohio
- University of Cincinnati College of Medicine - Dermatology — Cincinnati
Texas
- Arlington Research Center, Inc. | Arlington, TX — Arlington
Královéhradecký kraj
- Dermamedica s.r.o. — Náchod
Baden-Wurttemberg
- Hautarztpraxis Prof. Dr. med. Christian Termeer — Stuttgart
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2022-12-21 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05656911
The ClinicalTrials.gov registry entry for NCT05656911 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions — of which Zabedosertib (BAY1834845) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05656911 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Lombardy, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05656911 about?
NCT05656911 is a clinical study titled "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". 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 sometim...
What is the current status of trial NCT05656911?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2022-12-21. Estimated completion is 2024-01-31.
What conditions does trial NCT05656911 study?
This clinical trial studies the following conditions: Atopic Dermatitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05656911?
The interventions under investigation include: Zabedosertib (BAY1834845) (DRUG), Placebo to zabedosertib (BAY1834845) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05656911?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05656911 being conducted?
This trial has 20 study locations across Illinois, Massachusetts, Ohio, Texas, Královéhradecký kraj. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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