Clinical trial NCT06996912: A Study for HSK44459 in Participants With Atopic Dermatitis
Official title: A Phase 2 Study Investigating the Efficacy and Safety of HSK44459 Tablet Administered to Participants With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis (AD)
Keywords: Atopic dermatitis
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 outcomes:
measure: Percent change from baseline to week 12 in EASI
timeFrame: From Day 1 (first dose) to Day 85 (week 12)
Secondary outcomes:
measure: Proportion of patients with EASI-75 at week 12
timeFrame: From Day 1 (first dose) to Day 85 (week 12)
measure: Proportion of patients with both IGA 0 to 1and a reduction from baseline of ≥2 points at week 12
timeFrame: From Day 1 (first dose) to Day 85 (week 12)
measure: Proportion of patients with reduction of pruritus WI-NRS ≥3 or WI-NRS ≥4 from baseline to week 12
timeFrame: From Day 1 (first dose) to Day 85 (week 12)
Other outcomes:
Locations:
city: Jinan
country: China
facility: Affiliated Dermatology Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: