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 - Damask

Bayer AG0 个研究点目标入组 72 人开始时间: 2022年10月18日最近更新: 2024年4月2日

适应症

试验速览

暂无简介。

•1. 18 to 65 years of age inclusive, at the time of signing the informed consent.
•2. Diagnosis of atopic dermatitis (AD) for = 1 year at the screening visit.
•3. 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).
•4. 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).
•5. Stable amount of emollient applied to skin over the whole body twice daily for at least the 7 consecutive days before the randomization visit
•6. Body mass index (BMI) within the range of 18.5 to 35.0 kg/m2 (inclusive) at screening (Visit 1) and randomization visits.
•7. Women of childbearing potential and male subjects able to father children must agree to use adequate contraception when sexually active.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1. 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.
•2. 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.
•3. 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.
•4. Known immunodeficiency disorder or immunocompromised state or, in the opinion of the investigator, unacceptable risk for participating in the study.
•5. Use of topical treatments for AD within 7 days before the randomization visit.
•6. Systemic immunosuppressive/ immunomodulating therapy or phototherapy within 4 weeks before the randomization visit.
•7. Therapy with biologic drugs within 5 half-lives of the biologic drug
•8. Known hypersensitivity to the study drug

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