A Study for HSK44459 in Participants With Atopic Dermatitis

Launched by XIZANG HAISCO PHARMACEUTICAL CO., LTD · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HSK44459 for adults with atopic dermatitis, which is a long-term skin condition that causes itchy and inflamed skin. The main goal of the study is to see how effective and safe this treatment is for people who have had this condition for at least a year and have not had enough relief from other treatments. The trial is currently looking for participants aged 18 to 75 who have significant symptoms of atopic dermatitis and have been using moisturizers regularly.

If you decide to participate, you will need to provide written consent and meet certain criteria, such as having a specific severity of atopic dermatitis. Participants will be monitored closely and will follow the study's procedures over a set period. This is a great opportunity for those who have struggled to manage their condition with existing treatments to explore a potential new option.

Gender

ALL

Eligibility criteria

• 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