HSK44459: HSK44459 will be administered orally twice daily
Placebo: Placebo will be administered orally twice daily
Study summary
The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Percent change from baseline to week 12 in EASI — From Day 1 (first dose) to Day 85 (week 12) Evaluate the clinical efficacy of 2 dose levels of HSK44459, compared to placebo, in adult participants with atopic dermatitis (AD) using EASI.
A total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD
Trial sites (1)
Facility
City
Region
Status
Affiliated Dermatology Hospital of Shandong First Medical University
Jinan
Shandong
More Xizang Haisco Pharmaceutical Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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