Atopic Dermatitis (AD)Phase 2NCT06996912
A Study for HSK44459 in Participants With Atopic Dermatitis
A Phase 2 study testing HSK44459 in people with Atopic Dermatitis (AD), run by Xizang Haisco Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- HSK44459
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2025to 23 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, 250022
About this study
Official title: A Phase 2 Study Investigating the Efficacy and Safety of HSK44459 Tablet Administered to Participants With Atopic Dermatitis
The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis
Read the 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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- HSK44459, Placebo
- Keywords
- Atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK44459Drug
HSK44459 will be administered orally twice daily
PlaceboDrug
Placebo will be administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| HSK44459-Dose level 1 | Experimental | Participants will receive HSK44459 for 12 weeks Receives: Drug: HSK44459 |
| HSK44459-Dose level 2 | Experimental | Participants will receive HSK44459 for 12 weeks Receives: Drug: HSK44459 |
| Placebo | Placebo comparator | Participants will receive Placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Day 1 (first dose) to Day 85 (week 12)
Secondary outcomes (3)
Proportion of patients with EASI-75 at week 12
Proportion of patients with EASI-75 (≥75% improvement from baseline) at week 12
Measured: 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
The IGA determines severity of AD and clinical response to treatment on a 5-point scale
0 = Clear
- = Almost clear
- = Mild
- = Moderate
- = Severe
Measured: 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
The WI-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hour period.
Measured: From Day 1 (first dose) to Day 85 (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start22 May 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion23 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xizang Haisco Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996912
- Sponsor's protocol ID
- HSK44459-203
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Investigating the Efficacy and Safety of HSK44459 Tablet Administered to Participants With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06996912
- Acronym / sponsor ID
- HSK44459-203
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xizang Haisco Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 23 Mar 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK44459-Dose level 1 | Experimental | Drug: HSK44459Participants will receive HSK44459 for 12 weeks |
| HSK44459-Dose level 2 | Experimental | Drug: HSK44459Participants will receive HSK44459 for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Placebo for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK44459HSK44459 will be administered orally twice daily | Drug | HSK44459-Dose level 1, HSK44459-Dose level 2 |
| PlaceboPlacebo will be administered orally twice daily | Drug | Placebo |
Primary outcome
Percent change from baseline to week 12 in EASI
Time frame: 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
3 secondary outcomes
Proportion of patients with EASI-75 at week 12
Time frame: 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
Time frame: 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
Time frame: From Day 1 (first dose) to Day 85 (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK44459 in people with Atopic Dermatitis (AD), run by Xizang Haisco Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline to week 12 in EASI (time frame: From Day 1 (first dose) to Day 85 (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.