Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: BAY 1834845 coated tablet 120 mg
Product Code: BAY 1834845 coated tablet 120 mg 123
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Zabedosertib
CAS Number: 1931994-81-8
Current
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is 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.;Secondary Objective: The secondary objective is to assess the safety and tolerability of zabedosertib vs. placebo.;Primary end point(s): Number of participants having achievement of 75% reduction from baseline in the Eczema Area and Severity Index (EASI 75 response) at Week 12 (Day 84) ;Timepoint(s) of evaluation of this end point: up to Week 12 (Day 84) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percent change from baseline in EASI at Week 12 (Day 84) 2. Number of participants having achievement of EASI 50 response at Week 12 (Day 84) 3. Number of participants having achievement of EASI 90 response at Week 12 (Day 84) 4. Number of participants having achievement of a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response (score 0 or 1 and = 2 points improvement) at Week 12 (Day 84) 5. Absolute change from baseline in body surface area (BSA) affected by atopic dermatitis (AD) at Week 12 (Day 84) 6. Absolute values and percent change of weekly average of the Peak Pruritus 0-10 numerical rating scale (NRS) score from baseline at Week 12 (Day 84) 7. 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 8. Frequency and severity of treatment-emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1-7: up to Week 12 (Day 84) 8: up to 91 days | — |
Countries
Czechia, Czech Republic, France, Germany, Italy, Poland, United Kingdom, United States
Contacts
Public ContactTherapeutic Area Head
Bayer AG
Outcome results
None listed