A Study for HSK44459 in Participants With Atopic Dermatitis
- Registration Number
- NCT06996912
- Lead Sponsor
- Xizang Haisco Pharmaceutical Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HSK44459-Dose level 1 HSK44459 Participants will receive HSK44459 for 12 weeks HSK44459-Dose level 2 HSK44459 Participants will receive HSK44459 for 12 weeks Placebo Placebo Participants will receive Placebo for 12 weeks
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Proportion of patients with EASI-75 at week 12 From Day 1 (first dose) to Day 85 (week 12) Proportion of patients with EASI-75 (≥75% improvement from baseline) at week 12
Proportion of patients with both IGA 0 to 1and a reduction from baseline of ≥2 points at week 12 From Day 1 (first dose) to Day 85 (week 12) The IGA determines severity of AD and clinical response to treatment on a 5-point scale
0 = Clear
1. = Almost clear
2. = Mild
3. = Moderate
4. = SevereProportion of patients with reduction of pruritus WI-NRS ≥3 or WI-NRS ≥4 from baseline to week 12 From Day 1 (first dose) to Day 85 (week 12) The WI-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hour period.
Trial Locations
- Locations (1)
Affiliated Dermatology Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China