Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

Clinical Trial ID: NCT04212169

Description

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis. Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment. Approximately 108 participants will take part in this study. There is a 3 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.


Criteria

Inclusion Criteria: - Age 18 to 75 years inclusive at the time of consent. - Body mass index between 19.0 and 40.0 kg/m2 inclusive. - Documented history of chronic AD, for at least 1 year prior to screening Visit 1. - Meets at minimum 1 of the criteria, as follows: - History of inadequate response to topical medications for AD - Subject intolerance to treatment with topical medications for AD, or - Topical medications are otherwise medically inadvisable - AD that affects ≥ 10% of the body surface area (BSA). - An EASI score of ≥ 16. - An IGA score of ≥ 3. Exclusion Criteria: - Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results. - Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram ECG) or from safety laboratory analysis. - Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin. - Known active allergic or irritant contact dermatitis.

  • Start Date

    2019-12-09

  • Last Updated

    2019-12-24

  • Sponsor

    AstraZeneca

  • Condition Name

    Atopic Dermatitis

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