A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
NCT07920809, Phase 1, Not yet recruiting, Haisco Pharmaceutical Group Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis | ClinicalTrials.gov |
| NCT number | NCT07920809 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Haisco Pharmaceutical Group Co., Ltd. | ClinicalTrials.gov |
| Conditions | Dermatitis Atopic | ClinicalTrials.gov |
| Interventions | HSK60002 tablets, HSK60002 Placebo | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) | 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. | ClinicalTrials.gov |
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) of HSK60002 | Day 1 to Day 127 | ClinicalTrials.gov | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of HSK60002 | Day 1 to Day 127 | ClinicalTrials.gov | |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of HSK6000 | Day 1 to Day 127 | ClinicalTrials.gov | |
| Secondary | Terminal Elimination Half-Life (t1/2) of HSK60002 | Day 1 to Day 127 | ClinicalTrials.gov | |
| Secondary | Proportion of Participants Achieving at Least a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16 | Baseline (Day -1) to 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Achieving at Least a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI-50) at Week 16 | Baseline to 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. | ClinicalTrials.gov |
| Secondary | 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. | Baseline to Week 16 and follow-up | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in weekly average of daily Worst Itch Numeric Rating Scale (WI-NRS) score | Baseline to Week 16 and follow-up | 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 | ClinicalTrials.gov |
| Secondary | Change from baseline in percentage of body surface area (BSA) affected by Atopic Dermatitis (AD). | Baseline to Week 16 and follow-up | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in SCORing Atopic Dermatitis (SCORAD) score. | Baseline to Week 16 and follow-up | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score | Baseline to Week 16 and follow-up | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score | Baseline to Week 16 and follow-up | 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. | ClinicalTrials.gov |
| Secondary | STAT6 protein levels in whole blood and skin tissue and change from baseline. | Baseline to Week 16 and follow-up | ClinicalTrials.gov | |
| Secondary | Change from baseline in serum Th2 biomarker（TARC）. | Baseline to Week 16 and follow-up | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)