Evaluating HSK44459 for treating Atopic Dermatitis

A Phase 2 Study Investigating the Efficacy and Safety of HSK44459 Tablet Administered to Participants With Atopic Dermatitis

This study is testing a new treatment called HSK44459 to see if it can help adults with Atopic Dermatitis who haven't had enough relief from other treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (industry)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06996912 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, parallel group, placebo-controlled phase 2 study aims to evaluate the efficacy and safety of HSK44459 in adult participants diagnosed with Atopic Dermatitis. Participants will be randomly assigned to receive either the investigational drug HSK44459 or a placebo, with assessments made based on established clinical criteria. The study will involve adults aged 18 to 75 who have had Atopic Dermatitis for at least one year and have shown inadequate response to previous treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a history of Atopic Dermatitis and inadequate response to previous treatments.

Not a fit: Patients who have recently used certain Atopic Dermatitis treatments or have prior exposure to PDE4 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from Atopic Dermatitis.

How similar studies have performed: Other studies evaluating similar treatments for Atopic Dermatitis have shown promising results, indicating potential for success in this approach.

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

Where this trial is running

Jinan, Shandong

• Affiliated Dermatology Hospital of Shandong First Medical University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Yong Cao

Conditions: Atopic Dermatitis, Atopic dermatitis