Clinical Trial Results:
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
Summary
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EudraCT number |
2022-000520-38 |
Trial protocol |
CZ FR IT PL |
Global end of trial date |
28 Feb 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Mar 2025
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First version publication date |
05 Mar 2025
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BAY1834845/22158
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05656911 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bayer AG
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Sponsor organisation address |
Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
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Public contact |
Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
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Scientific contact |
Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Feb 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Feb 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the efficacy of zabedosertib vs. placebo in adult patients with moderate-to-severe atopic dermatitis (AD) with inadequate response to topical corticosteroids or if topical treatments are medically not advisable.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects (or their legally authorized representative according to local legislation). Participating subjects (or their legally authorized representative according to local legislation) signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
All subjects had to use a stable amount of emollient as background therapy during the course of the study. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Dec 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 5
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Country: Number of subjects enrolled |
United States: 5
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Country: Number of subjects enrolled |
Poland: 14
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Country: Number of subjects enrolled |
Czechia: 30
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Country: Number of subjects enrolled |
France: 7
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Country: Number of subjects enrolled |
Germany: 8
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Country: Number of subjects enrolled |
Italy: 8
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Worldwide total number of subjects |
77
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EEA total number of subjects |
67
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
77
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Study was conducted at 22 centers in Europe and US between 21-DEC-2022 (first subject first visit) and 31-JAN-2024 (last subject last visit). | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 129 subjects were screened in this study. Of those, 52 did not pass screening (44 were screened failures, 1 was physician decision, 6 were subject decision, 1 was other reasons). A total of 77 subjects were randomized. | |||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment phase
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Zabedosertib (BAY1834845) | |||||||||||||||||||||||||||
Arm description |
Subjects received zabedosertib for up to 12 weeks (84 days). | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Zabedosertib
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Investigational medicinal product code |
BAY1834845
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
120 mg, oral administration, two times a day
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Arm title
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Placebo | |||||||||||||||||||||||||||
Arm description |
Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days). | |||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||
Investigational medicinal product name |
Matching placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
oral administration, two times a day
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Period 2
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Period 2 title |
Follow-up phase
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Is this the baseline period? |
No | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Zabedosertib (BAY1834845) | |||||||||||||||||||||||||||
Arm description |
Subjects received zabedosertib for up to 12 weeks (84 days). | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Zabedosertib
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Investigational medicinal product code |
BAY1834845
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
120 mg, oral administration, two times a day
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Arm title
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Placebo | |||||||||||||||||||||||||||
Arm description |
Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days). | |||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||
Investigational medicinal product name |
Matching placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
oral administration, two times a day
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Baseline characteristics reporting groups
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Reporting group title |
Zabedosertib (BAY1834845)
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Reporting group description |
Subjects received zabedosertib for up to 12 weeks (84 days). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Zabedosertib (BAY1834845)
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Reporting group description |
Subjects received zabedosertib for up to 12 weeks (84 days). | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days). | ||
Reporting group title |
Zabedosertib (BAY1834845)
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Reporting group description |
Subjects received zabedosertib for up to 12 weeks (84 days). | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days). | ||
Subject analysis set title |
Per protocol set (PPS)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
All randomized subjects who: had an EASI score at baseline; had an EASI score at Day 56 (Visit 6) or later or took rescue medication between Day 56 (Visit 6) and Day 84 (Visit 7) or took standard of care or discontinued study intervention due to lack of efficacy (at any time); showed compliance of at least 80% with study intervention between start of treatment and end of treatment or start of rescue medication at or after Day 56 (Visit 6), whatever comes first; showed compliance of at least 80% with study intervention during the last 4 weeks before end of treatment or start of rescue medication at or after Day 56 (Visit 6), whatever comes first; without validity findings with respect to the efficacy related entry criteria.
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Subject analysis set title |
Safety analysis set (SAF)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who took at least 1 dose of study intervention.
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End point title |
Achievement of 75% reduction from baseline in the Eczema Area and Severity Index (EASI 75 response) at Week 12 (Day 84) | ||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
Week 12 (Day 84)
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Notes [1] - PPS [2] - PPS |
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Statistical analysis title |
Bayesian analysis according to estimand | ||||||||||||
Statistical analysis description |
Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
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Comparison groups |
Zabedosertib (BAY1834845) v Placebo
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | ||||||||||||
Method |
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Parameter type |
Median difference (final values) | ||||||||||||
Point estimate |
-5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-29 | ||||||||||||
upper limit |
18 | ||||||||||||
Notes [3] - Posterior probability is 34.0%. |
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End point title |
Percent change from baseline in EASI at Week 12 (Day 84) | ||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12 (Day 84)
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Notes [4] - PPS [5] - PPS |
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Statistical analysis title |
ANCOVA analysis | ||||||||||||
Statistical analysis description |
The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.
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Comparison groups |
Zabedosertib (BAY1834845) v Placebo
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.257 [6] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
11.31
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-8.26 | ||||||||||||
upper limit |
30.87 | ||||||||||||
Notes [6] - two-sided. No adjustment for multiple comparisons. |
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End point title |
Achievement of EASI 50 response at Week 12 (Day 84) | ||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Week 12 (Day 84)
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Notes [7] - PPS [8] - PPS |
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Statistical analysis title |
Bayesian analysis according to estimand | ||||||||||||
Statistical analysis description |
Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
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Comparison groups |
Zabedosertib (BAY1834845) v Placebo
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
other [9] | ||||||||||||
Method |
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Parameter type |
Median difference (final values) | ||||||||||||
Point estimate |
-2.7
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-27 | ||||||||||||
upper limit |
22.1 | ||||||||||||
Notes [9] - Posterior probability is 41.7%. |
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End point title |
Achievement of EASI 90 response at Week 12 (Day 84) | ||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Week 12 (Day 84)
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Notes [10] - PPS [11] - PPS |
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Statistical analysis title |
Bayesian analysis according to estimand | ||||||||||||
Statistical analysis description |
Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
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Comparison groups |
Zabedosertib (BAY1834845) v Placebo
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
other [12] | ||||||||||||
Method |
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Parameter type |
Median difference (final values) | ||||||||||||
Point estimate |
-4.6
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-25.6 | ||||||||||||
upper limit |
13.4 | ||||||||||||
Notes [12] - Posterior probability is 31.5%. |
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End point title |
Achievement of a vIGA-AD response (score 0 or 1 and ≥ 2 points improvement) at Week 12 (Day 84) | ||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Week 12 (Day 84)
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Notes [13] - PPS [14] - PPS |
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Statistical analysis title |
Bayesian analysis according to estimand | ||||||||||||
Statistical analysis description |
Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
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Comparison groups |
Zabedosertib (BAY1834845) v Placebo
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
other [15] | ||||||||||||
Method |
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Parameter type |
Median difference (final values) | ||||||||||||
Point estimate |
-12.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-34.1 | ||||||||||||
upper limit |
7 | ||||||||||||
Notes [15] - Posterior probability is 10.8%. |
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End point title |
Absolute change from baseline in body surface area (BSA) affected by atopic dermatitis (AD) at Week 12 (Day 84) | ||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12 (Day 84)
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Notes [16] - PPS [17] - PPS |
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Statistical analysis title |
ANCOVA analysis | ||||||||||||
Statistical analysis description |
The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.
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Comparison groups |
Zabedosertib (BAY1834845) v Placebo
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Number of subjects included in analysis |
69
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.166 [18] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
7.06
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.92 | ||||||||||||
upper limit |
17.03 | ||||||||||||
Notes [18] - two-sided. No adjustment for multiple comparisons. |
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End point title |
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 subjects with Peak Pruritus 0-10 NRS score ≥ 4 at baseline | ||||||||||||
End point description |
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.
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End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline and Week 12 (Day 84)
|
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|
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Notes [19] - PPS [20] - PPS |
|||||||||||||
Statistical analysis title |
Bayesian analysis according to estimand | ||||||||||||
Statistical analysis description |
Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
|
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Comparison groups |
Zabedosertib (BAY1834845) v Placebo
|
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Number of subjects included in analysis |
69
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other [21] | ||||||||||||
Method |
|||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Point estimate |
-8.4
|
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
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lower limit |
-30.4 | ||||||||||||
upper limit |
11 | ||||||||||||
Notes [21] - Posterior probability is 20.5%. |
|
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End point title |
Absolute values of weekly average of the Peak Pruritus 0-10 numerical rating scale (NRS) score at Week 12 (Day 84) | ||||||||||||
End point description |
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.
|
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End point type |
Secondary
|
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End point timeframe |
Week 12 (Day 84)
|
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Notes [22] - PPS [23] - PPS |
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No statistical analyses for this end point |
|
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End point title |
Percent change of weekly average of the Peak Pruritus 0-10 NRS score from baseline at Week 12 (Day 84) | ||||||||||||
End point description |
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.
|
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End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline and Week 12 (Day 84)
|
||||||||||||
|
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Notes [24] - PPS [25] - PPS |
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Statistical analysis title |
ANCOVA analysis | ||||||||||||
Statistical analysis description |
The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.
|
||||||||||||
Comparison groups |
Zabedosertib (BAY1834845) v Placebo
|
||||||||||||
Number of subjects included in analysis |
69
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.396 [26] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
6.68
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-8.75 | ||||||||||||
upper limit |
22.11 | ||||||||||||
Notes [26] - two-sided. No adjustment for multiple comparisons. |
|
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End point title |
Frequency and severity of treatment-emergent adverse events (TEAEs) | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
|
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End point timeframe |
From first treatment with the study intervention until 7 days after the last intake of study intervention (approximately up to 91 days)
|
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|
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Notes [27] - SAF [28] - SAF |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events tables: from the start of study intervention until 7 days after the last intake (approximately up to 91 days). The deaths (all causes) considers all deaths that occurred at any time during the study before the last contact, up to 20 weeks.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
Zabedosertib (BAY1834845)
|
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Reporting group description |
Subjects received zabedosertib for up to 12 weeks (84 days) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |