Dermatitis AtopicPhase 1NCT07920809
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
A Phase 1 study testing HSK60002 tablets in people with Dermatitis Atopic, run by Haisco Pharmaceutical Group Co., Ltd..
Trial summary
This is a randomized, double-blind, placebo-controlled, Phase Ib study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HSK60002 tablets in approximately 60 participants with moderate-to-severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatitis Atopic
- What is being tested?
- HSK60002 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 1
- 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
- Capable of understanding and voluntarily providing informed consent before participating in any study-specific procedures.
- Aged 18 to 75 years, inclusive, of any sex.
- Able to understand and complete study-related questionnaires/scales, agree to photographic documentation of skin lesions, and comply with the visit schedule and other protocol requirements.
- Diagnosed with atopic dermatitis according to the 2014 American Academy of Dermatology (AAD) criteria, with a history of AD or eczema for at least 6 months before screening, and stable AD disease, in the investigator's judgment, within 4 weeks before signing the informed consent form.
- EASI score ≥16 at both screening and baseline visits.
- vIGA-AD score ≥3 at both screening and baseline visits.
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- AD-involved body surface area (BSA) ≥10% at both screening and baseline visits.
- Weekly average of daily Worst Itch Numeric Rating Scale (WI-NRS) score ≥4 at baseline.
- In the investigator's judgment, inadequate clinical response to and/or intolerance of AD topical therapy within 6 months before screening, or disease controlled with systemic therapy.
- Use of a stable dose of drug-free topical emollient applied twice daily for at least 7 consecutive days before the baseline visit, with continued use throughout the study.
- Agreement to use highly effective contraception throughout the study.
Who cannot join
- Any of the following treatments before the baseline visit: dupilumab or stapokibart (anti-IL-4Rα biologics) within 6 weeks; other known or potentially AD-affecting biologics within 12 weeks; systemic medications for AD within 4 weeks; topical AD therapy within 7 days; phototherapy for AD within 4 weeks.
- Prior treatment with IL-4R- or IL-13-targeted biologics or JAK inhibitors with inadequate clinical response, in the investigator's judgment.
- Administration of live attenuated vaccines within 12 weeks before baseline, or planned vaccination during the study.
- Use of antihistamines within 1 week before baseline.
- Allergen-specific immunotherapy within 6 months before baseline.
- Use of any investigational product within 4 weeks or 5 half-lives before randomization, whichever is longer.
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- Clinically significant abnormal laboratory findings during screening.
- Other active skin diseases or skin infections that may affect the assessment of AD treatment response, as assessed by the investigator.
- Clinically significant chest X-ray or CT abnormality at screening.
- Possible active Mycobacterium tuberculosis infection; history of TB infection or current TB infection.
- History of invasive opportunistic infections.
- Rheumatic fever, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, multiple sclerosis, Sjögren's syndrome, inflammatory bowel disease, or other autoimmune diseases that may affect efficacy and safety assessment, as evaluated by the investigator.
- Asthma requiring high-dose inhaled corticosteroids, systemic corticosteroids, or biologic therapy.
- Major surgery within 3 months before screening or planned during the study.
- Uncontrolled blood pressure despite antihypertensive treatment within 3 months before screening.
- Thromboembolic events within 6 months before screening.
- Uncontrolled clinically significant major medical conditions that would pose a safety risk, in the investigator's opinion.
- History of malignancy within 5 years before screening.
- History of atopic keratoconjunctivitis (AKC) involving the cornea, or history of vernal keratoconjunctivitis (VKC).
- Dysphagia, gastrointestinal surgery, or severe gastrointestinal disease that may interfere with the pharmacokinetics of the study drug.
- Active hepatitis B, positive hepatitis C antibody, syphilis infection, or HIV infection during screening.
- History of drug abuse, illicit drug use, or alcohol abuse within 3 months before screening.
- Use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 28 days before the first dose of study drug.
- Consumption of grapefruit (or grapefruit-containing products) within 48 hours before the first dose of study drug, or unwillingness to abstain during the study.
- History of severe drug allergy or known allergy to the study drug or its excipients.
- Pregnant or lactating women, or women planning pregnancy or lactation during the study.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
This is a randomized, double-blind, placebo-controlled, Phase Ib study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HSK60002 tablets in approximately 60 participants with moderate-to-severe atopic dermatitis (AD). Participants are randomized within one of three dose groups (10 mg once daily [QD], 30 mg QD, or 30 mg once weekly [QW]) in a 4:1 ratio to HSK60002 or matching placebo. Treatment is given orally for up to 16 weeks (Stage 1: Weeks 1-4; Stage 2: Weeks 5-16), followed by a safety follow-up visit approximately 2 weeks after the last dose.
- Conditions
- Dermatitis Atopic
- Being tested
- HSK60002 tablets, HSK60002 Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK60002 tabletsDrug
HSK60002 tablets, oral administration.
HSK60002 PlaceboDrug
Placebo tablets, oral administration.
| Study group | Role | What they receive |
|---|---|---|
| HSK60002 Dose 1 QD | Experimental | Not described Receives: Drug: HSK60002 tablets; Drug: HSK60002 Placebo |
| HSK60002 Dose 2 QD | Experimental | Not described Receives: Drug: HSK60002 tablets; Drug: HSK60002 Placebo |
| HSK60002 Dose 1 QW | Experimental | Not described Receives: Drug: HSK60002 tablets; Drug: HSK60002 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
Safety and tolerability of HSK60002 tablets assessed by the incidence and severity of AEs, SAEs, and AESI, clinical laboratory tests (hematology, blood chemistry, urinalysis), 12-lead ECG, T-SPOT.TB test, chest X-ray or CT, vital signs, and physical examination.
Measured: From first dose (Day 1) through Week 16 (end of treatment) and the safety follow-up visit approximately 2 weeks after the last dose.
Secondary outcomes (14)
Area Under the Plasma Concentration-Time Curve (AUC) of HSK60002
Measured: Day 1 to Day 127
Maximum Observed Plasma Concentration (Cmax) of HSK60002
Measured: Day 1 to Day 127
Time to Reach Maximum Plasma Concentration (Tmax) of HSK6000
Measured: Day 1 to Day 127
Terminal Elimination Half-Life (t1/2) of HSK60002
Measured: Day 1 to Day 127
Proportion of Participants Achieving at Least a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
The Eczema Area and Severity Index (EASI) is a composite measure of the extent and severity of atopic dermatitis, with total scores ranging from 0 (no disease) to 72 (most severe disease); higher scores indicate more severe disease. EASI-75 is defined as at least a 75% improvement (reduction) in EASI score from baseline.
Measured: Baseline (Day -1) to Week 16
Proportion of Participants Achieving at Least a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI-50) at Week 16
The Eczema Area and Severity Index (EASI) is a composite measure of the extent and severity of atopic dermatitis, with total scores ranging from 0 (no disease) to 72 (most severe disease); higher scores indicate more severe disease. EASI-50 is defined as at least a 50% improvement (reduction) in EASI score from baseline.
Measured: Baseline to Week 16
Proportion of participants achieving a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with a reduction of ≥2 points from baseline.
The validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) is a 5-point scale ranging from 0 (clear) to 4 (severe), with higher scores indicating more severe disease. Treatment success is defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline.
Measured: Baseline to Week 16 and follow-up
Change from baseline in weekly average of daily Worst Itch Numeric Rating Scale (WI-NRS) score
The Worst Itch Numeric Rating Scale (WI-NRS) is an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating worse itch severity
Measured: Baseline to Week 16 and follow-up
Change from baseline in percentage of body surface area (BSA) affected by Atopic Dermatitis (AD).
The percentage of body surface area (BSA) affected by atopic dermatitis ranges from 0% (no involvement) to 100% (full-body involvement), with higher percentages indicating greater extent of disease.
Measured: Baseline to Week 16 and follow-up
Change from baseline in SCORing Atopic Dermatitis (SCORAD) score.
The SCORing Atopic Dermatitis (SCORAD) index is a composite measure of disease extent, intensity, and subjective symptoms (itch and sleep loss). Total scores range from 0 (no disease) to 103 (most severe disease), with higher scores indicating more severe atopic dermatitis.
Measured: Baseline to Week 16 and follow-up
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score
The Patient-Oriented Eczema Measure (POEM) is a 7-item patient-reported questionnaire assessing symptoms of atopic dermatitis (itch, sleep disturbance, dryness, flaking, cracking, bleeding, and oozing/weeping) over the previous week. Total scores range from 0 (no symptoms) to 28 (most severe symptoms), with higher scores indicating more severe disease.
Measured: Baseline to Week 16 and follow-up
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
The Dermatology Life Quality Index (DLQI) is a 10-item patient-reported questionnaire assessing the impact of skin disease on quality of life over the previous week, covering symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment burden. Total scores range from 0 (no impact) to 30 (maximum impact), with higher scores indicating greater impairment of quality of life.
Measured: Baseline to Week 16 and follow-up
STAT6 protein levels in whole blood and skin tissue and change from baseline.
Measured: Baseline to Week 16 and follow-up
Change from baseline in serum Th2 biomarker（TARC）.
Measured: Baseline to Week 16 and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis AtopicStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920809
- Sponsor's protocol ID
- HSK60002-104
- Status last verified
- Nov 2026
- First submitted
- 16 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07920809
- Acronym / sponsor ID
- HSK60002-104
- Conditions
- Dermatitis Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
This is a randomized, double-blind, placebo-controlled, Phase Ib study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HSK60002 tablets in approximately 60 participants with moderate-to-severe atopic dermatitis (AD). Participants are randomized within one of three dose groups (10 mg once daily [QD], 30 mg QD, or 30 mg once weekly [QW]) in a 4:1 ratio to HSK60002 or matching placebo. Treatment is given orally for up to 16 weeks (Stage 1: Weeks 1-4; Stage 2: Weeks 5-16), followed by a safety follow-up visit approximately 2 weeks after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK60002 Dose 1 QD | Experimental | Drug: HSK60002 tablets, Drug: HSK60002 Placebo |
| HSK60002 Dose 2 QD | Experimental | Drug: HSK60002 tablets, Drug: HSK60002 Placebo |
| HSK60002 Dose 1 QW | Experimental | Drug: HSK60002 tablets, Drug: HSK60002 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Capable of understanding and voluntarily providing informed consent before participating in any study-specific procedures.
- Aged 18 to 75 years, inclusive, of any sex.
- Able to understand and complete study-related questionnaires/scales, agree to photographic documentation of skin lesions, and comply with the visit schedule and other protocol requirements.
- Diagnosed with atopic dermatitis according to the 2014 American Academy of Dermatology (AAD) criteria, with a history of AD or eczema for at least 6 months before screening, and stable AD disease, in the investigator's judgment, within 4 weeks before signing the informed consent form.
- EASI score ≥16 at both screening and baseline visits.
Key exclusion criteria (27 listed)
- Any of the following treatments before the baseline visit: dupilumab or stapokibart (anti-IL-4Rα biologics) within 6 weeks; other known or potentially AD-affecting biologics within 12 weeks; systemic medications for AD within 4 weeks; topical AD therapy within 7 days; phototherapy for AD within 4 weeks.
- Prior treatment with IL-4R- or IL-13-targeted biologics or JAK inhibitors with inadequate clinical response, in the investigator's judgment.
- Administration of live attenuated vaccines within 12 weeks before baseline, or planned vaccination during the study.
- Use of antihistamines within 1 week before baseline.
- Allergen-specific immunotherapy within 6 months before baseline.
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 |
|---|---|---|
| HSK60002 tabletsHSK60002 tablets, oral administration. | Drug | HSK60002 Dose 1 QD, HSK60002 Dose 1 QW, HSK60002 Dose 2 QD |
| HSK60002 PlaceboPlacebo tablets, oral administration. | Drug | HSK60002 Dose 1 QD, HSK60002 Dose 1 QW, HSK60002 Dose 2 QD |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
Time frame: From first dose (Day 1) through Week 16 (end of treatment) and the safety follow-up visit approximately 2 weeks after the last dose.
Safety and tolerability of HSK60002 tablets assessed by the incidence and severity of AEs, SAEs, and AESI, clinical laboratory tests (hematology, blood chemistry, urinalysis), 12-lead ECG, T-SPOT.TB test, chest X-ray or CT, vital signs, and physical examination.
14 secondary outcomes
Area Under the Plasma Concentration-Time Curve (AUC) of HSK60002
Time frame: Day 1 to Day 127
Maximum Observed Plasma Concentration (Cmax) of HSK60002
Time frame: Day 1 to Day 127
Time to Reach Maximum Plasma Concentration (Tmax) of HSK6000
Time frame: Day 1 to Day 127
Terminal Elimination Half-Life (t1/2) of HSK60002
Time frame: Day 1 to Day 127
Proportion of Participants Achieving at Least a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16
Time frame: Baseline (Day -1) to Week 16
Proportion of Participants Achieving at Least a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI-50) at Week 16
Time frame: Baseline to Week 16
Proportion of participants achieving a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with a reduction of ≥2 points from baseline.
Time frame: Baseline to Week 16 and follow-up
Change from baseline in weekly average of daily Worst Itch Numeric Rating Scale (WI-NRS) score
Time frame: Baseline to Week 16 and follow-up
Change from baseline in percentage of body surface area (BSA) affected by Atopic Dermatitis (AD).
Time frame: Baseline to Week 16 and follow-up
Change from baseline in SCORing Atopic Dermatitis (SCORAD) score.
Time frame: Baseline to Week 16 and follow-up
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score
Time frame: Baseline to Week 16 and follow-up
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time frame: Baseline to Week 16 and follow-up
STAT6 protein levels in whole blood and skin tissue and change from baseline.
Time frame: Baseline to Week 16 and follow-up
Change from baseline in serum Th2 biomarker（TARC）.
Time frame: Baseline to Week 16 and follow-up
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 6 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK60002 tablets in people with Dermatitis Atopic, run by Haisco Pharmaceutical Group Co., Ltd..
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 11 inclusion and 27 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Yongrui Wang (+86-28-67258840, wangyr@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) (time frame: From first dose (Day 1) through Week 16 (end of treatment) and the safety follow-up visit approximately 2 weeks after the last dose.). 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 6 Nov 2026.