Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe 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.

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 152 participants will take part in this study. There is a 4 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.

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.