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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
* 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.
You may not be if
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
Clareo Health | 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
