Atopic DermatitisPhase 2DamaskNCT05656911
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 testing Zabedosertib (BAY1834845) in people with Atopic Dermatitis, run by Bayer at 22 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Zabedosertib (BAY1834845)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 21 Dec 2022to 31 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States4 sites
Arlington Research Center, Inc. | Arlington, TX
Arlington, Texas, 76011
Beth Israel Deaconess Medical Center - Dermatology
Boston, Massachusetts, 02115
University of Cincinnati College of Medicine - Dermatology
Cincinnati, Ohio, 45219
NorthShore University HealthSystem | Skokie Hospital - Dermatology Department
Skokie, Illinois, 60077
Italy4 sites
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, Sicily, 95123
A.O.U. di Ferrara
Ferrara, Emilia-Romagna, 44124
Humanitas Research Hospital | Cardio Center - Clinical, Interventional Cardiology and Coronary Care
Milan, Lombardy, 20089
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Poland4 sites
Dermal NZOZ Sp Osrodek Dermatologiczny Bialystok-Podlasie
Bialystok, 15-453
Centrum Nowoczesnych Terapii Dobry Lekarz
Krakow, 31-011
Santa Sp. z o.o.
Lodz, 90-302
Royalderm Agnieszka Nawrocka
Warsaw, 02-962
Czechia3 sites
Dermamedica s.r.o.
Náchod, Hradec Králové Region, 547 01
Clintrial s.r.o.
Prague, 100 00
Praglandia
Prague, 150 00
France3 sites
Clinique Bezannes
Bezannes, 51430
Centre Hospitalier Universitaire Nice | L'Archet Hospital - Dermatology Department
Nice, 6202
Hôpital Saint Louis
Paris, 75010
Germany2 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Hautarztpraxis Prof. Dr. med. Christian Termeer
Stuttgart, Baden-Wurttemberg, 70499
United Kingdom2 sites
Whipps Cross University Hospital - Clinical Research Unit
Leytonstone, London, E11 1NR
Medicines Evaluation Unit
Wythenshawe, Manchester, M23 9QZ
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Phase 2a Study to Investigate Efficacy and Safety of Zabedosertib (BAY 1834845) for the Treatment of Adult Patients 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 sometimes the immune system can be too sensitive and overreact. This may then lead to allergies but also to skin conditions like atopic dermatitis.
Read more
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
- Being tested
- Zabedosertib (BAY1834845), Placebo to zabedosertib (BAY1834845)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zabedosertib (BAY1834845)Drug
Oral administration, two times a day
Placebo to zabedosertib (BAY1834845)Drug
Oral administration, two times a day
| Study group | Role | What they receive |
|---|---|---|
| Zabedosertib | Experimental | Participants will receive zabedosertib for up to 12 weeks (84 days). Receives: Drug: Zabedosertib (BAY1834845) |
| Matching placebo to zabedosertib | Placebo comparator | Participants will receive placebo to zabedosertib for up to 12 weeks (84 days). Receives: Drug: Placebo to zabedosertib (BAY1834845) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of 75% Reduction From Baseline in the Eczema Area and Severity Index (EASI 75 Response) at Week 12 (Day 84)
The endpoint was the composite variable defined as follows: - an EASI 75 response at Week 12 (Day 84), - no stop of study intervention for reasons related to lack of efficacy, - no rescue medication use during the 4 weeks before Day 84 and - no use of systemic atopic dermatitis (AD) treatment. The main estimand was the difference in the proportion of responders between treatment groups in adults with moderate-to-severe atopic dermatitis where use of topical rescue medication from Day 56 (Visit 6) onwards, use of systemic standard of care for AD and discontinuation of treatment due to lack of efficacy are handled as non-response (composite strategy). The estimand was regardless of use of rescue medication before Day 56 (Visit 6), regardless of non-compliance with emollients, and had treatment not been discontinued due to other reasons not related to lack of efficacy. Bayesian analysis according to estimand is presented.
Measured: Week 12 (Day 84)
Secondary outcomes (9)
Percent Change From Baseline in EASI at Week 12 (Day 84)
The EASI is a ClinRO assessing the extent of AD at four body regions by measuring the average severity of four clinical signs at each body region, each on a scale of 0 to 3. The minimum EASI score is 0 and the maximum EASI score is 72, with a higher score indicating worse severity of AD. The main estimand was based on the same strategies to address intercurrent events as described above for the primary endpoint. The mean difference between the treatment arms was used as summary measure.
Measured: Baseline and Week 12 (Day 84)
Achievement of EASI 50 Response at Week 12 (Day 84)
The EASI is a ClinRO assessing the extent of AD at four body regions by measuring the average severity of four clinical signs at each body region, each on a scale of 0 to 3. The minimum EASI score is 0 and the maximum EASI score is 72, with a higher score indicating worse severity of AD. EASI 50 corresponds to the achievement of 50% reduction from baseline in EASI. The main estimand was calculated similarly as for EASI 75. Bayesian analysis according to estimand is presented.
Measured: Week 12 (Day 84)
Achievement of EASI 90 Response at Week 12 (Day 84)
The EASI is a ClinRO assessing the extent of AD at four body regions by measuring the average severity of four clinical signs at each body region, each on a scale of 0 to 3. The minimum EASI score is 0 and the maximum EASI score is 72, with a higher score indicating worse severity of AD. EASI 90 corresponds to the achievement of 90% reduction from baseline in EASI. The main estimand was calculated similarly as for EASI 75. Bayesian analysis according to estimand is presented.
Measured: Week 12 (Day 84)
Achievement of a vIGA-AD Response (Score 0 or 1 and ≥ 2 Points Improvement) at Week 12 (Day 84)
vIGA-AD stands for validated Investigator Global Assessment for Atopic Dermatitis. The vIGA-AD is a 1-item static ClinRO using a 5-point scale from 0 (clear) to 4 (severe) based on 4 clinical features of AD lesions: erythema, induration/papulation, lichenification, and oozing/crusting, and takes extent of disease into account. The main estimand was calculated similarly as for EASI 75. Bayesian analysis according to estimand is presented.
Measured: Week 12 (Day 84)
Absolute Change From Baseline in Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 (Day 84)
BSA affected by AD was assessed for each section of the body, e.g. using the rule of nines. The possible highest score for each region is: Head and neck - 9%; Anterior trunk - 18%; Back - 18%; Upper limbs - 18%; Lower limbs - 36%; Genitals - 1%. Affected BSA was reported as a percentage of all major body sections combined. The main estimand was based on the same strategies to address intercurrent events as described above for the primary endpoint. The mean difference between the treatment arms was used as summary measure.
Measured: Baseline and Week 12 (Day 84)
Achievement of a ≥ 4 Point-improvement (Reduction) in the Weekly Average of the Peak Pruritus 0-10 NRS Score From Baseline to Week 12 (Day 84) for Participants With Peak Pruritus 0-10 NRS Score ≥ 4 at Baseline
NRS stands for numerical rating scale. The Peak Pruritus 0-10 NRS is a single patient-reported item designed to measure peak pruritus (itch), or 'worst' itch, over the previous 24 h based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?'. ≥ 4 points reduction of the Peak Pruritus 0-10 NRS is considered a clinically relevant within-person response. NRS was assessed on a daily basis and the average over the last 7 days before the visit day was used for analysis. The main estimand was calculated similarly as for EASI 75. Bayesian analysis according to estimand is presented.
Measured: Baseline and Week 12 (Day 84)
Absolute Values of Weekly Average of the Peak Pruritus 0-10 Numerical Rating Scale (NRS) Score at Week 12 (Day 84)
The Peak Pruritus 0-10 NRS is a single patient-reported item designed to measure peak pruritus (itch), or 'worst' itch, over the previous 24 h based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?'. ≥ 4 points reduction of the Peak Pruritus 0-10 NRS is considered a clinically relevant within-person response. NRS was assessed on a daily basis and the average over the last 7 days before the visit day was used for analysis. The main estimand was based on the same strategies to address intercurrent events as described above for the primary endpoint.
Measured: Week 12 (Day 84)
Percent Change of Weekly Average of the Peak Pruritus 0-10 NRS Score From Baseline at Week 12 (Day 84)
The Peak Pruritus 0-10 NRS is a single patient-reported item designed to measure peak pruritus (itch), or 'worst' itch, over the previous 24 h based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?'. ≥ 4 points reduction of the Peak Pruritus 0-10 NRS is considered a clinically relevant within-person response. NRS was assessed on a daily basis and the average over the last 7 days before the visit day was used for analysis. The main estimand was based on the same strategies to address intercurrent events as described above for the primary endpoint. ANCOVA analysis according to estimand is presented.
Measured: Baseline and Week 12 (Day 84)
Frequency and Severity of Treatment-emergent Adverse Events (TEAEs)
Measured: From first treatment with the study intervention until 7 days after the last intake of study intervention (approximately up to 91 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start21 Dec 2022
- Primary completion3 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656911
- Sponsor's protocol ID
- 22158
- Other IDs
- 2022-000520-38
- Acronym
- Damask
- Status last verified
- Feb 2025
- First submitted
- 29 Nov 2022
- Last updated
- 18 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
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 Nov;15(11):3329-3345. doi: 10.1007/s13555-025-01505-z. Epub 2025 Sep 4.
PubMed 40906353
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Phase 2a Study to Investigate Efficacy and Safety of Zabedosertib (BAY 1834845) for the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05656911
- Acronym / sponsor ID
- Damask / 22158
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Posted 18 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zabedosertib | Experimental | Drug: Zabedosertib (BAY1834845)Participants will receive zabedosertib for up to 12 weeks (84 days). |
| Matching placebo to zabedosertib | Placebo comparator | Drug: Placebo to zabedosertib (BAY1834845)Participants will receive placebo to zabedosertib for up to 12 weeks (84 days). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zabedosertib (BAY1834845)Oral administration, two times a day | Drug | Zabedosertib |
| Placebo to zabedosertib (BAY1834845)Oral administration, two times a day | Drug | Matching placebo to zabedosertib |
Primary outcome
Achievement of 75% Reduction From Baseline in the Eczema Area and Severity Index (EASI 75 Response) at Week 12 (Day 84)
Time frame: Week 12 (Day 84)
The endpoint was the composite variable defined as follows: - an EASI 75 response at Week 12 (Day 84), - no stop of study intervention for reasons related to lack of efficacy, - no rescue medication use during the 4 weeks before Day 84 and - no use of systemic atopic dermatitis (AD) treatment. The main estimand was the difference in the proportion of responders between treatment groups in adults with moderate-to-severe atopic dermatitis where use of topical rescue medication from Day 56 (Visit 6) onwards, use of systemic standard of care for AD and discontinuation of treatment due to lack of efficacy are handled as non-response (composite strategy). The estimand was regardless of use of rescue medication before Day 56 (Visit 6), regardless of non-compliance with emollients, and had treatment not been discontinued due to other reasons not related to lack of efficacy. Bayesian analysis according to estimand is presented.
9 secondary outcomes
Percent Change From Baseline in EASI at Week 12 (Day 84)
Time frame: Baseline and Week 12 (Day 84)
Achievement of EASI 50 Response at Week 12 (Day 84)
Time frame: Week 12 (Day 84)
Achievement of EASI 90 Response at Week 12 (Day 84)
Time frame: Week 12 (Day 84)
Achievement of a vIGA-AD Response (Score 0 or 1 and ≥ 2 Points Improvement) at Week 12 (Day 84)
Time frame: Week 12 (Day 84)
Absolute Change From Baseline in Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 (Day 84)
Time frame: Baseline and Week 12 (Day 84)
Achievement of a ≥ 4 Point-improvement (Reduction) in the Weekly Average of the Peak Pruritus 0-10 NRS Score From Baseline to Week 12 (Day 84) for Participants With Peak Pruritus 0-10 NRS Score ≥ 4 at Baseline
Time frame: Baseline and Week 12 (Day 84)
Absolute Values of Weekly Average of the Peak Pruritus 0-10 Numerical Rating Scale (NRS) Score at Week 12 (Day 84)
Time frame: Week 12 (Day 84)
Percent Change of Weekly Average of the Peak Pruritus 0-10 NRS Score From Baseline at Week 12 (Day 84)
Time frame: Baseline and Week 12 (Day 84)
Frequency and Severity of Treatment-emergent Adverse Events (TEAEs)
Time frame: From first treatment with the study intervention until 7 days after the last intake of study intervention (approximately up to 91 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40906353Jodl 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 Nov;15(11):3329-3345. doi: 10.1007/s13555-025-01505-z. Epub 2025 Sep 4.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zabedosertib (BAY1834845) in people with Atopic Dermatitis, run by Bayer at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Italy, Poland, Czechia, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of 75% Reduction From Baseline in the Eczema Area and Severity Index (EASI 75 Response) at Week 12 (Day 84) (time frame: Week 12 (Day 84)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.