Atopic dermatitis MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: •Subject has provided informed consent prior to initiation of any study specific activities/procedures •Age = 18 to = 75 years at screening •Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 2 years prior to screening and has confirmed AD •AD that affects = 10% body surface area as assessed by EASI at screening and on day 1 •An IGA score of = 3 at screening and on day 1 •An EASI score of = 16 at screening and on day 1 •Subject discontinued treatment with TCS, topical calcineurin inhibitors (TCI), and prescription moisturizers for at least the 7 days immediately prior to the first dose of investigational product •Documented recent history (within 12 months before the screening visit) of inadequate response to treatment with topical TCS or subjects for whom topical treatments are otherwise medically inadvisable (ie, because of important side effects or safety risks) - Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to IGA 0 = clear to IGA 2 = mild) despite treatment with a daily regimen of TCS of medium or higher potency (with orwithout TCI as appropriate). 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 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Subjects are excluded from the study if any of the following criteria apply: •Active dermatologic conditions, which might confound the diagnosis of AD or would interfere with the assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, allergic contact dermatitis, or irritant contact dermatitis •History of a clinically significant infection within 28 days prior to day 1 that, in the opinion of the investigator or medical monitor, might compromise the safety of the subject in the study, interfere with evaluation of the investigational product, or reduce the subject’s ability to participate in the study. Clinically significant infections are defined as either of the following: - 1) a systemic infection; or - 2) a serious skin infection requiring parenteral antibiotic, antiviral, or antifungal medication •Diagnosis of a helminth parasitic infection within 6 months prior to screening that had not been treated with or had failed to respond to standard of care therapy •Documented medical history of chronic alcohol or drug abuse within 12 months prior to screening •History of anaphylaxis following any biologic therapy •Evidence of active liver disease at screening, including jaundice or aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN) •Diagnosis and/or treatment of tuberculosis within the 12 months prior to screening. Patients with latent tuberculosis: recommendation is to evaluate by tests according to national guidelines (using Quantiferon TB Gold or PPD). •Positive hepatitis B surface antigen or hepatitis C antibody serology. Subjects with a history of hepatitis B vaccination without a history of hepatitis B are allowed to enroll in the study. •Positive human immunodeficiency virus (HIV) test at screening or the subject is taking antiretroviral medications, as determined by medical history, prior medications, and/or the subject’s verbal report •History of malignancy, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy = 12 months prior to screening or other malignancies treated with apparent success with curative therapy = 5 years prior to screening •History or evidence of severe depression, schizophrenia, previous suicide attempts, or suicidal ideation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: • To evaluate the effect of tezepelumab compared with placebo, assessed using the Investigator’s Global Assessment (IGA) and Eczema Area and Severity Index (EASI). Part B: • Part B is an estimation study; no hypotheses will be formally tested.;Secondary Objective: Part A: • To estimate the effect of tezepelumab compared with placebo on the efficacy measure of EASI. • To estimate the time needed to reach EASI 50/75/90. • To estimate the effect of tezepelumab compared with placebo on the efficacy measure of Scoring Atopic Dermatitis (SCORAD). • To estimate the effect of tezepelumab compared with placebo on the patient-reported outcome (PRO) measure of pruritus assessed using an numeric rating scale (NRS). • To characterize the pharmacokinetics (PK) of tezepelumab. Part B: • Part B is an estimation study; no hypotheses will be formally tested.;Primary end point(s): Part A: • IGA score of 0 (clear) or 1 (almost clear) (IGA 0/1) at week 16 • 75% reduction in EASI (EASI 75) at week 16;Timepoint(s) of evaluation of this end point: • week 16 • week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: • 50% and 90% reduction in EASI (EASI 50/90) at week 16 • Time at which EASI 50/75/90 is achieved from day 1 • SCORAD at week 16 • Pruritus NRS at week 16 • Serum trough concentrations of tezepelumab at scheduled visits ;Timepoint(s) of evaluation of this end point: • week 16 • monthly • week 16 • week 16 • week 2, 4, and 24 | — |
Countries
Australia, Canada, Czech Republic, Estonia, Germany, Hungary, Japan, Korea, Republic of, Latvia, Poland, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed