PRA-216 Atopic Dermatitis Safety and Efficacy Study

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy response of PRA-216 in patients with moderate to severe Atopic Dermatitis (AD). Eligible participants will be those with AD who are inadequately controlled by topical corticosteroids (TCS) or had adverse reaction or contraindication to the medication.

This study will enroll approximately 39 participants at multiple study sites who will be randomized 2:1 to receive either PRA-216 or placebo subcutaneous injections four times throughout the study period.

Inclusion criteria

• Must be in good health with no significant medical history
• Willing and able to attend all study visits, comply with study requirements.
• Able and willing to provide written informed consent
• Documented AD diagnosis prior for at least 6 months prior to enrollment.
• History of inadequate response to topical medications for AD

Exclusion criteria

• Evidence of clinically significant skin condition or disease other than AD
• Any physical or psychological condition that prohibits study completion
• Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent
• History of severe allergic reactions or hypersensitivity
• Receipt of antibody therapy within 4 months or 5 half-lives
• Other investigational agent(s) within 30 days or 5 half-lives