Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2022-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Age 18 to 65 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 ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).

• 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.