Plaque PsoriasisPhase 2NCT07158268
A Phase 2 Study of HSK47388 Tablets to Evaluate the Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing HSK47388 in people with Plaque Psoriasis, run by Haisco Pharmaceutical Group Co., Ltd..
Trial summary
The primary objective of this study is to evaluate the efficacy of multiple-dose HSK47388 versus placebo in participants with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- HSK47388
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 17 Jan 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of plaque psoriasis with a disease duration of at least 26 weeks before the first administration of the study intervention
- Total Body Surface Area (BSA) involvement ≥ 10% at both screening and baseline visits
- Psoriasis Area and Severity Index (PASI) total score ≥ 12 at both screening and baseline visits
- Investigator Global Assessment (IGA) for plaque psoriasis total score ≥ 3 (moderate or severe disease) at both screening and baseline visits
- Participants deemed appropriate candidates for systemic therapy for plaque psoriasis
Who cannot join
- Non-plaque psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)
- Current drug-induced psoriasis
- Current diagnosis, signs, or symptoms of severe, progressive, or uncontrolled disease involving the renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic systems
- Known allergy, hypersensitivity, or intolerance to HSK47388。
- A history of malignant tumor before screening;
- Subjects deemed unsuitable for participation due to other factors as determined by the investigator
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-blind and Two-Stage Study to Evaluate the Efficacy and Safety of HSK47388 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
The primary objective of this study is to evaluate the efficacy of multiple-dose HSK47388 versus placebo in participants with moderate-to-severe plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- HSK47388
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK47388Drug
HSK47388 tablets will be administered orally, once a day
| Study group | Role | What they receive |
|---|---|---|
| HSK47388 matching placebo will be administered orally. | Placebo comparator | Not described Receives: Drug: HSK47388 |
| HSK47388 dose 1 will be administered orally. | Experimental | Not described Receives: Drug: HSK47388 |
| HSK47388 dose 2 will be administered orally. | Experimental | Not described Receives: Drug: HSK47388 |
| HSK47388 dose 3 will be administered orally. | Experimental | Not described Receives: Drug: HSK47388 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSK47388 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to week 16
Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system for assessing/grading psoriatic lesion severity and treatment response. It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale). PASI yields a 0-72 numeric score, where higher scores mean more severe disease.
Measured: 16 weeks
Secondary outcomes (4)
HSK47388 and placebo Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16
The percentage of participants with IGA 0/1 and ≥2-grade improvement from baseline at Weeks 16 will be reported. IGA is investigators' assessment of participants' psoriasis at a specific time point, grading overall lesions by induration, erythema, scaling, and categorizing psoriasis as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Measured: 16 weeks
Change From Baseline in Body Surface Area (BSA) at Week 16
Change from baseline in BSA at Week 16 will be reported. BSA is a common measure of skin disease extent, defined as the percentage of total body surface area affected by the target condition (i.e., plaque psoriasis).
Measured: 16 weeks
HSK47388 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16
Change from baseline in total DLQI score at Week 16 will be reported. The DLQI is a dermatology-specific HRQoL instrument designed to assess a disease's impact on participants' HRQoL. It is a 10-item questionnaire evaluating HRQoL over the past week; in addition to overall HRQoL, it assesses 6 quality-of-life domains: symptoms/feelings, daily activities, leisure, work/school performance, personal relationships, and treatment. Total scores range from 0 to 30, with higher scores indicating greater HRQoL impact.
Measured: 16 weeks
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion17 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 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
- NCT07158268
- Sponsor's protocol ID
- HSK47388-201
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-blind and Two-Stage Study to Evaluate the Efficacy and Safety of HSK47388 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07158268
- Acronym / sponsor ID
- HSK47388-201
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 17 Jan 2027 (estimated)
- First posted
- 5 Sep 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 primary objective of this study is to evaluate the efficacy of multiple-dose HSK47388 versus placebo in participants with moderate-to-severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSK47388 matching placebo will be administered orally. | Placebo comparator | Drug: HSK47388 |
| HSK47388 dose 1 will be administered orally. | Experimental | Drug: HSK47388 |
| HSK47388 dose 2 will be administered orally. | Experimental | Drug: HSK47388 |
| HSK47388 dose 3 will be administered orally. | Experimental | Drug: HSK47388 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of plaque psoriasis with a disease duration of at least 26 weeks before the first administration of the study intervention
- Total Body Surface Area (BSA) involvement ≥ 10% at both screening and baseline visits
- Psoriasis Area and Severity Index (PASI) total score ≥ 12 at both screening and baseline visits
- Investigator Global Assessment (IGA) for plaque psoriasis total score ≥ 3 (moderate or severe disease) at both screening and baseline visits
- Participants deemed appropriate candidates for systemic therapy for plaque psoriasis
Key exclusion criteria (6 listed)
- Non-plaque psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)
- Current drug-induced psoriasis
- Current diagnosis, signs, or symptoms of severe, progressive, or uncontrolled disease involving the renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic systems
- Known allergy, hypersensitivity, or intolerance to HSK47388。
- A history of malignant tumor before screening;
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 |
|---|---|---|
| HSK47388HSK47388 tablets will be administered orally, once a day | Drug | HSK47388 dose 1 will be administered orally., HSK47388 dose 2 will be administered orally., HSK47388 dose 3 will be administered orally., HSK47388 matching placebo will be administered orally. |
Primary outcome
HSK47388 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to week 16
Time frame: 16 weeks
Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system for assessing/grading psoriatic lesion severity and treatment response. It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale). PASI yields a 0-72 numeric score, where higher scores mean more severe disease.
4 secondary outcomes
HSK47388 and placebo Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16
Time frame: 16 weeks
Change From Baseline in Body Surface Area (BSA) at Week 16
Time frame: 16 weeks
HSK47388 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16
Time frame: 16 weeks
Number of Participants with Adverse Events (AEs)
Time frame: 20 weeks
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 5 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK47388 in people with Plaque Psoriasis, 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 5 inclusion and 6 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 5 Sep 2025. 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. 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?
HSK47388 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to week 16 (time frame: 16 weeks). 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 5 Sep 2025.