A Study for HSK44459 in Participants With Atopic Dermatitis

A Phase 2 Study Investigating the Efficacy and Safety of HSK44459 Tablet Administered to Participants With Atopic Dermatitis

The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis

This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of HSK44459 in adult participants with Atopic Dermatitis.

Inclusion Criteria:

• Written informed consent must be obtained
• Male or female, ≥18 years old and ≤75 years old
• Willing and able to comply with study-specific procedures and the requirements of this study protocol.
• Atopic dermatitis has been present for at least 1 year and subject meets Hanifin and Rajka criteria
• EASI score≥16 at the screening and baseline visits
• IGA score≥3 at the screening and baseline visits
• ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits
• Baseline WI-NRS≥4
• History of inadequate response to TCS of medium to higher potency (with or without topical calcineurin inhibitors [TCI]) or systemic treatment for AD within 6 months prior to screening
• Have applied a stable dose of topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit

Exclusion Criteria:

• Subjects have used AD treatments within the time frame specified in protocol prior to the baseline visit
• Prior exposure to any PDE4 inhibitor systemic treatment
• Systemic use of known strong CYP3A inhibitors or strong CYP3A inducers within 4 weeks or 5 half-lives prior to randomization or during the course of the study
• Participation in other clinical studies within 4 weeks or 5 half-lives prior to randomization
• Subjects have laboratory values meeting the criteria in protocol
• Presence of skin comorbidities that may interfere with study assessments
• Concurrent conditions and history of other diseases as described in protocol