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NCT05656911 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Atopic Dermatitis, sponsored by Bayer.

Completed
Registry status
Phase 2
Development phase
77
Enrollment target
20
Study locations

NCT05656911 is a Phase 2 study of Atopic Dermatitis that has completed, run by Bayer. The registered enrollment target is 77 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT05656911, a Phase 2 study of Atopic Dermatitis, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 2
Development phase
77 participants
Enrollment target
20
Study locations

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

Atopic Dermatitis

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

FieldValue
Enrollment Target 77 participants
Start Date 2022-12-21
Est. Completion 2024-01-31
Phase Phase 2

Sponsor

Bayer

591 total trials

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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, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (87% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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.

NCT05656911 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Lombardy, Illinois.

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.

What interventions are being tested in trial NCT05656911?

The interventions under investigation include: Zabedosertib (BAY1834845) (DRUG), Placebo to zabedosertib (BAY1834845) (DRUG).

Who is sponsoring clinical trial NCT05656911?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

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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