A Dose-Ranging, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

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 containing TCS or TCI 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

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)
- Subjects who, in the opinion of the investigator, have evidence of active tuberculosis (TB), either treated or untreated, or a positive QuantiFERON-tuberculosis Gold (QFT-G) test for TB during screening.
Subjects with an indeterminate QFT-G may be enrolled if they have ALL of the following:
? - No symptoms of TB: productive, prolonged cough (> 3 weeks); coughing up blood; fever; night sweats; unexplained appetite loss; unintentional weight loss
? - No evidence of active TB on chest radiograph within 3 months prior to the first dose of investigational product. Note: Chest radiograph is not part of screening procedure and will be the responsibility of the Investigator as this is outside the scope of this protocol
•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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