Atopic Dermatitis (AD)
Conditions
Keywords
Atopic dermatitis
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.
Interventions
DRUGHSK44459
HSK44459 will be administered orally twice daily
DRUGPlacebo
Placebo will be administered orally twice daily
Sponsors
Xizang Haisco Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. = Severe |
| Proportion 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. |
Countries
China
Outcome results
None listed