A Phase 1 interventional study of HSK60002 tablets and HSK60002 Placebo in Dermatitis Atopic, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 60 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 118 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HSK60002 tablets · Drug: HSK60002 Placebo
Drug: HSK60002 tablets · Drug: HSK60002 Placebo
Drug: HSK60002 tablets · Drug: HSK60002 Placebo
HSK60002 tablets, oral administration.
Placebo tablets, oral administration.
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.
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.
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
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.
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
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.
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.
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.
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Haisco Pharmaceutical Group Co., Ltd. →