A Phase 2 interventional study of Zabedosertib (BAY1834845) and Placebo to zabedosertib (BAY1834845) in Atopic Dermatitis, sponsored by Bayer. Completed at 22 sites in 7 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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:
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 77 is close to the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Moderate-to-severe AD at randomization visit as defined by
Exclusion Criteria:
Participants will receive zabedosertib for up to 12 weeks (84 days).
Drug: Zabedosertib (BAY1834845)
Participants will receive placebo to zabedosertib for up to 12 weeks (84 days).
Drug: Placebo to zabedosertib (BAY1834845)
Oral administration, two times a day
Oral administration, two times a day
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.
Time frame: Week 12 (Day 84)
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.
Time frame: 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.
Time frame: 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.
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)
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.
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)
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.
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
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.
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)
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.
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)
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.
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)
Study was conducted at 22 centers in Europe and US between 21-DEC-2022 (first participant first visit) and 31-JAN-2024 (last participant last visit).
| Milestone | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Started | 52 | 25 |
| Completed | 36 | 19 |
| Not completed | 16 | 6 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Lack of efficacy | 6 | 3 |
| Withdrew: Subject decision | 4 | 2 |
| Withdrew: Other reasons | 1 | 0 |
| Withdrew: Adverse event | 3 | 1 |
| Milestone | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Started | 36 | 19 |
| Completed | 35 | 18 |
| Not completed | 1 | 1 |
| Withdrew: Subject decision | 0 | 1 |
| Withdrew: Missing | 1 | 0 |
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.
| Percentage (%) | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Achievement of 75% Reduction From Baseline in the Eczema Area and Severity Index (EASI 75 Response) at Week 12 (Day 84) | 32.3 | 37.4 |
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.
| percentage (%) of change | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Percent Change From Baseline in EASI at Week 12 (Day 84) | -44.58 (-55.96 to -33.19) | -55.88 (-71.91 to -39.85) |
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.
| Percentage (%) | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Achievement of EASI 50 Response at Week 12 (Day 84) | 52.7 | 55.4 |
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.
| Percentage (%) | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Achievement of EASI 90 Response at Week 12 (Day 84) | 15.6 | 20.4 |
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.
| Percentage (%) | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Achievement of a vIGA-AD Response (Score 0 or 1 and ≥ 2 Points Improvement) at Week 12 (Day 84) | 15.9 | 28.5 |
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.
| percentage of BSA (%) | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Absolute Change From Baseline in Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 (Day 84) | -13.28 (-18.98 to -7.58) | -20.34 (-28.60 to -12.07) |
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.
| Percentage (%) | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| 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 | 16.4 | 25.0 |
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.
| Scores on a scale | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Absolute Values of Weekly Average of the Peak Pruritus 0-10 Numerical Rating Scale (NRS) Score at Week 12 (Day 84) | 5.759 ± 2.218 | 5.36 ± 2.311 |
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.
| percentage of change (%) | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Percent Change of Weekly Average of the Peak Pruritus 0-10 NRS Score From Baseline at Week 12 (Day 84) | -20.65 (-29.54 to -11.77) | -27.33 (-40.00 to -14.66) |
| Participants | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| Any AE | 23 | 7 |
| Maximum intensity for any AE -MILD | 13 | 4 |
| Maximum intensity for any AE -MODERATE | 10 | 3 |
| Any SAE | 0 | 0 |
| AE with outcome death | 0 | 0 |
Collected over Adverse events tables: from the start of study intervention until 7 days after the last intake (approximately up to 91 days). All-cause mortality is considered after signing informed consent up to the last contact per participant, up to 20 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zabedosertib (BAY1834845) | 0/52 (0%) | 0/52 (0%) | 23/52 (44.2%) |
| Placebo | 0/25 (0%) | 0/25 (0%) | 7/25 (28%) |
| Event | Zabedosertib (BAY1834845) | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 4/52 | 1/25 |
| Sinus arrhythmiaCardiac disorders | 0/52 | 1/25 |
| HypersensitivityImmune system disorders | 0/52 | 1/25 |
| PustuleInfections and infestations | 1/52 | 1/25 |
| Upper respiratory tract infectionInfections and infestations | 0/52 | 1/25 |
| Oral herpesInfections and infestations | 0/52 | 1/25 |
| Rib fractureInjury, poisoning and procedural complications | 0/52 | 1/25 |
| Limb injuryInjury, poisoning and procedural complications | 0/52 | 1/25 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/52 | 1/25 |
| Pregnancy of partnerSocial circumstances | 0/52 | 1/25 |
Safety analysis set (SAF): All participants who took at least 1 dose of study intervention.
| Age, Continuous(years) | Zabedosertib (BAY1834845) | Placebo | Total |
|---|---|---|---|
| Mean | 35.2 ± 11.3 | 32.9 ± 10.3 | 34.4 ± 11.0 |
| Sex: Female, Male(Participants) | Zabedosertib (BAY1834845) | Placebo | Total |
|---|---|---|---|
| Female | 26 | 7 | 33 |
| Male | 26 | 18 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Zabedosertib (BAY1834845) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 50 | 24 | 74 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Zabedosertib (BAY1834845) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 47 | 22 | 69 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Plan to share: 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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