A Study for HSK44459 in Participants With Atopic Dermatitis

NCT06996912 | Active Not Recruiting Phase 2

• 1 other identifier: HSK44459-203
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline to week 12 in EASI

  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

  From Day 1 (first dose) to Day 85 (week 12)

Secondary Outcomes (3)

• Proportion of patients with EASI-75 at week 12

  From Day 1 (first dose) to Day 85 (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)

• 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)

Study Arms (3)

HSK44459-Dose level 1

EXPERIMENTAL

Participants will receive HSK44459 for 12 weeks

Drug: HSK44459

HSK44459-Dose level 2

EXPERIMENTAL

Participants will receive HSK44459 for 12 weeks

Drug: HSK44459

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo for 12 weeks

Drug: Placebo

Interventions

HSK44459 DRUG

HSK44459 will be administered orally twice daily

HSK44459-Dose level 1; HSK44459-Dose level 2

Placebo DRUG

Placebo will be administered orally twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xizang Haisco Pharmaceutical Co., Ltd: lead

Study Sites (1)

Affiliated Dermatology Hospital of Shandong First Medical University

Jinan, Shandong, 250022, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 22, 2025
• Primary Completion: January 20, 2026
• Study Completion: March 23, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)