Status:
ACTIVE_NOT_RECRUITING
A Study for HSK44459 in Participants With Atopic Dermatitis
Lead Sponsor:
Xizang Haisco Pharmaceutical Co., Ltd
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 23 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06996912
Start Date
May 22 2025
End Date
March 23 2026
Last Update
January 2 2026
Active Locations (1)
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1
Affiliated Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, China, 250022