A Study for HSK44459 in Participants With Atopic Dermatitis
NCT ID: NCT06996912
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-05-22
2026-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HSK44459-Dose level 1
Participants will receive HSK44459 for 12 weeks
HSK44459
HSK44459 will be administered orally twice daily
HSK44459-Dose level 2
Participants will receive HSK44459 for 12 weeks
HSK44459
HSK44459 will be administered orally twice daily
Placebo
Participants will receive Placebo for 12 weeks
Placebo
Placebo will be administered orally twice daily
Interventions
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HSK44459
HSK44459 will be administered orally twice daily
Placebo
Placebo will be administered orally twice daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Xizang Haisco Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Affiliated Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, China
Countries
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Other Identifiers
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HSK44459-203
Identifier Type: -
Identifier Source: org_study_id
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