PsoriasisPhase 2NCT06926582
A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis
A Phase 2 study testing HS-10374 6mg tablets in people with Psoriasis, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- HS-10374 6mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2025to 9 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between the ages of 18-70 years
- Diagnosis of plaque psoriasis for at least 6 months
- sPGA score of 2-3, BSA 2-15%, PASI score 2-15
- Subject must be inadequately controlled with, or intolerant of at least one topical therapy
Who cannot join
- Diagnosis of non-plaque psoriasis or drug-induced psoriasis
- Recent history of infection, history or risk of serious infection
- Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
- Any condition possibly affecting the PK process of the study drug
- Evidence of other skin conditions that would interfere with the evaluation of psoriasis
- History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
Show all 9Show fewer
- Prior exposure to TYK2 inhibitors
- Have received the prohibited treatment during the protocol required washout period
- Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200443
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Clinical Efficacy and Safety of HS-10374 in Adult Patients With Mild-to-moderate Plaque Psoriasis
This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.
Read the detailed description
This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.
- Conditions
- Psoriasis
- Being tested
- HS-10374 6mg tablets, HS-10374-matched placebo tablets
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10374 6mg tabletsDrug
Administered orally QD for 12 weeks
HS-10374-matched placebo tabletsDrug
Administered orally QD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| HS-10374 Dose 1 | Experimental | Not described Receives: Drug: HS-10374 6mg tablets; Drug: HS-10374-matched placebo tablets |
| HS-10374 Dose 2 | Experimental | Not described Receives: Drug: HS-10374 6mg tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: HS-10374-matched placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12
Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.
Measured: Baseline to Week 12
Secondary outcomes (13)
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Measured: Baseline to Week 16
Number of participants with clinical laboratory abnormalities
Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, C-reactive protein, etc.
Measured: Baseline to Week 16
Incidence of clinically significant changes in electrocardiogram (ECG)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Measured: Baseline to Week 16
Number of participants with abnormalities of physical examination
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Measured: Baseline to Week 16
Number of participants with abnormalities of vital signs
Vital signs measured include blood pressure, pulse rate, and temperature.
Measured: Baseline to Week 16
Proportion of patients with sPGA 0/1 at specified time points
Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.
Measured: Baseline to Week 16
Proportion of patients achieving BSA 75 response at specified time points
Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved. BSA 75 response is defined as 75% or greater improvement in BSA score from baseline.
Measured: Baseline to Week 16
Change from baseline in BSA at specified time points
Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.
Measured: Baseline to Week 16
Proportion of patients who achieved BSA ≤ 1% at specified time points
Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.
Measured: Baseline to Week 16
Change from baseline in PASI at specified time points
Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity.
Measured: Baseline to Week 16
Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points
Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.
Measured: Baseline to Week 16
Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points
Scalp specific physician's global assessment (sPGA) of psoriasis is an assessment of the disease severity of scalp psoriasis based on erythema, thickness, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "absence of disease" or "very mild disease" respectively.
Measured: Baseline to Week 16
Change from baseline in DLQI scores at specified time points
The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment).
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start9 Apr 2025 (estimated)
- Primary completion9 Jul 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuling Shi, MD, Principal investigator, Shanghai Dermatology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926582
- Sponsor's protocol ID
- HS-10374-205
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Clinical Efficacy and Safety of HS-10374 in Adult Patients With Mild-to-moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06926582
- Acronym / sponsor ID
- HS-10374-205
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (estimated)
- Primary completion
- 9 Jul 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 13 Apr 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.
This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.
Detailed description
This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HS-10374 Dose 1 | Experimental | Drug: HS-10374 6mg tablets, Drug: HS-10374-matched placebo tablets |
| HS-10374 Dose 2 | Experimental | Drug: HS-10374 6mg tablets |
| Placebo | Placebo comparator | Drug: HS-10374-matched placebo tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects between the ages of 18-70 years
- Diagnosis of plaque psoriasis for at least 6 months
- sPGA score of 2-3, BSA 2-15%, PASI score 2-15
- Subject must be inadequately controlled with, or intolerant of at least one topical therapy
Key exclusion criteria (9 listed)
- Diagnosis of non-plaque psoriasis or drug-induced psoriasis
- Recent history of infection, history or risk of serious infection
- Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
- Any condition possibly affecting the PK process of the study drug
- Evidence of other skin conditions that would interfere with the evaluation of psoriasis
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 |
|---|---|---|
| HS-10374 6mg tabletsAdministered orally QD for 12 weeks | Drug | HS-10374 Dose 1, HS-10374 Dose 2 |
| HS-10374-matched placebo tabletsAdministered orally QD for 12 weeks | Drug | HS-10374 Dose 1, Placebo |
Primary outcome
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12
Time frame: Baseline to Week 12
Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.
13 secondary outcomes
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time frame: Baseline to Week 16
Number of participants with clinical laboratory abnormalities
Time frame: Baseline to Week 16
Incidence of clinically significant changes in electrocardiogram (ECG)
Time frame: Baseline to Week 16
Number of participants with abnormalities of physical examination
Time frame: Baseline to Week 16
Number of participants with abnormalities of vital signs
Time frame: Baseline to Week 16
Proportion of patients with sPGA 0/1 at specified time points
Time frame: Baseline to Week 16
Proportion of patients achieving BSA 75 response at specified time points
Time frame: Baseline to Week 16
Change from baseline in BSA at specified time points
Time frame: Baseline to Week 16
Proportion of patients who achieved BSA ≤ 1% at specified time points
Time frame: Baseline to Week 16
Change from baseline in PASI at specified time points
Time frame: Baseline to Week 16
Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points
Time frame: Baseline to Week 16
Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points
Time frame: Baseline to Week 16
Change from baseline in DLQI scores at specified time points
Time frame: Baseline to Week 16
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 13 Apr 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.
Yuling Shi, MD principal investigator
Shanghai Dermatology Hospital
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 HS-10374 6mg tablets in people with Psoriasis, run by Hansoh BioMedical R&D Company 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 4 inclusion and 9 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 13 Apr 2025. 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?
Contact Yuling Shi, MD ((0086)021-61833000, shiyuling1973@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12 (time frame: Baseline to 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 13 Apr 2025.