PsoriasisPhase 3NCT06672393
A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
A Phase 3 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 confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 375 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to 29 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male or female subjects aged 18 years and older
- Diagnosis of plaque psoriasis for at least 6 months
- Eligible for phototherapy or systemic therapy
- Plaque covering ≥ 10% of BSA
- PASI ≥ 12, sPGA ≥3
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
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- 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.
China1 site
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis
This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.
Read the detailed description
This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.
- 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
Specified dose of HS-10374 tablets administered orally QD on specified days
HS-10374-matched placebo tabletsDrug
Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days
| Study group | Role | What they receive |
|---|---|---|
| HS-10374 | Experimental | Subjects will receive HS-10374 from Week 0 through Week 52. Receives: Drug: HS-10374 6mg tablets |
| Placebo | Placebo comparator | Subjects will receive HS-10374 matching placebo from Week 0 through Week 16, and HS-10374 from Week 16 through Week 52. Receives: Drug: HS-10374 6mg tablets; 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 PASI 75 response at Week 16
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. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.
Measured: Baseline to Week 16
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16
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
Secondary outcomes (15)
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Measured: Baseline to Week 56
Number of participants with clinical laboratory abnormalities
Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc.
Measured: Baseline to Week 56
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 56
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 56
Number of participants with abnormalities of vital signs
Vital signs measured include blood pressure, pulse rate, and temperature.
Measured: Baseline to Week 56
PASI 75 response rates 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. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.
Measured: Baseline to Week 56
PASI 90 response rates 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. PASI 90 response is defined as 90% or greater improvement in PASI score from baseline.
Measured: Baseline to Week 56
PASI 100 response rates 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. PASI 100 response is defined as 100% improvement in PASI score from baseline.
Measured: Baseline to Week 56
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 56
Proportion of patients with sPGA 0 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 means "clear".
Measured: Baseline to Week 56
Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1
Psoriasis symptoms and signs diary (PSSD) is an 11-item patient-reported instrument. It assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 subject-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated from 0 (absent) to 10 (worst imaginable). Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
Measured: Baseline to Week 56
Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2
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 56
Proportion of patients achieving ss-PGA 0/1 at Week 16 among patients with a baseline ss-PGA score ≥3
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
Proportion of patients achieving PGA-F 0/1 at Week 16 among patients with a baseline PGA-F score ≥3
Physician's global assessment of fingernails (PGA-F) is a scale used to assess a patient's fingernail psoriasis. Ten fingernails on the hand will be globally evaluated separately for nail bed and nail matrix disease on a scale of 0 to 4. The overall global assessment of nails is the worse of the nail bed and nail matrix assessment. A PGA-F score of 0 or 1 means "clear" or "minimal" respectively.
Measured: Baseline to Week 16
Proportion of patients achieving pp-PGA 0/1 at Week 16 among patients with a baseline pp-PGA score ≥3
Palmoplantar PGA (pp-PGA) is a scale performed by investigators to assess a patient's palmoplantar psoriasis lesions on a scale of 0 to 4. A pp-PGA score of 0 or 1 means "clear" or "almost clear" respectively.
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 posted4 Nov 2024
- Study start4 Nov 2024 (estimated)
- Primary completion22 Oct 2025 (estimated)
- Study completion29 Jun 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672393
- Sponsor's protocol ID
- HS-10374-301
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- 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 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06672393
- Acronym / sponsor ID
- HS-10374-301
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 22 Oct 2025 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 4 Nov 2024 (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 confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.
Detailed description
This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10374 | Experimental | Drug: HS-10374 6mg tabletsSubjects will receive HS-10374 from Week 0 through Week 52. |
| Placebo | Placebo comparator | Drug: HS-10374 6mg tablets, Drug: HS-10374-matched placebo tabletsSubjects will receive HS-10374 matching placebo from Week 0 through Week 16, and HS-10374 from Week 16 through Week 52. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 18 years and older
- Diagnosis of plaque psoriasis for at least 6 months
- Eligible for phototherapy or systemic therapy
- Plaque covering ≥ 10% of BSA
- PASI ≥ 12, sPGA ≥3
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 tabletsSpecified dose of HS-10374 tablets administered orally QD on specified days | Drug | HS-10374, Placebo |
| HS-10374-matched placebo tabletsSpecified dose of HS-10374-matched placebo tablets administered orally QD on specified days | Drug | Placebo |
Primary outcome
Proportion of patients achieving PASI 75 response at Week 16
Time frame: Baseline to Week 16
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. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16
Time frame: Baseline to Week 16
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.
15 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 56
Number of participants with clinical laboratory abnormalities
Time frame: Baseline to Week 56
Incidence of clinically significant changes in electrocardiogram (ECG)
Time frame: Baseline to Week 56
Number of participants with abnormalities of physical examination
Time frame: Baseline to Week 56
Number of participants with abnormalities of vital signs
Time frame: Baseline to Week 56
PASI 75 response rates at specified time points
Time frame: Baseline to Week 56
PASI 90 response rates at specified time points
Time frame: Baseline to Week 56
PASI 100 response rates at specified time points
Time frame: Baseline to Week 56
Proportion of patients with sPGA 0/1 at specified time points
Time frame: Baseline to Week 56
Proportion of patients with sPGA 0 at specified time points
Time frame: Baseline to Week 56
Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1
Time frame: Baseline to Week 56
Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2
Time frame: Baseline to Week 56
Proportion of patients achieving ss-PGA 0/1 at Week 16 among patients with a baseline ss-PGA score ≥3
Time frame: Baseline to Week 16
Proportion of patients achieving PGA-F 0/1 at Week 16 among patients with a baseline PGA-F score ≥3
Time frame: Baseline to Week 16
Proportion of patients achieving pp-PGA 0/1 at Week 16 among patients with a baseline pp-PGA score ≥3
Time frame: Baseline to Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 5 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: status not confirmed, as of the sponsor's last update on 4 Nov 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinhua Xu, MD ((+86)13818978539, xjhhsyy@163.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 PASI 75 response at Week 16 (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. 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 4 Nov 2024.