PsoriasisPhase 2NCT06077331
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
A Phase 2 study testing HS-10374 tablets 1mg and HS-10374 tablets 5mg 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 moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374. 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 tablets 1mg and HS-10374 tablets 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2023to 31 Aug 2024
- Phase
- Phase 2
- 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 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
- 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
Show all 9Show fewer
- History of lack of response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 at approved doses after at least 3 months of therapy
- 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, 1 recruiting
- Recruiting
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Jinhua Xu, PhD, +86-13818978539, xjhhsyy@163.com
About this study
Official title: A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 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 explore the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.
Read the detailed description
This is a 12-week, multi-center, randomized, double blind, placebo-controlled, Phase 2 study. The study duration includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned to 1 of 3 treatment arms (HS-10374 Dose 1, HS-10374 Dose 2, and placebo) in an equal ratio.
- Conditions
- Psoriasis
- Being tested
- HS-10374 tablets 1mg, HS-10374 tablets 5mg, 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 tablets 1mgDrug
Administered orally QD for 12 weeks
HS-10374 tablets 5mgDrug
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 tablets 1mg; Drug: HS-10374 tablets 5mg; Drug: HS-10374-matched placebo tablets |
| HS-10374 Dose 2 | Experimental | Not described Receives: Drug: HS-10374 tablets 1mg; Drug: HS-10374 tablets 5mg |
| Placebo | Active 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 with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12
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 12
Secondary outcomes (14)
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, high-sensitivity C-reactive protein, 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
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
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
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
PASI 50 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 50 response is defined as 50% or greater improvement in PASI score from baseline.
Measured: Baseline to Week 16
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 16
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 16
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 16
Change from baseline in PASI scores 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
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
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
Ctrough
Trough observed plasma concentration.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start28 Sep 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinhua Xu, Principal investigator, Huashan HospitalYangfeng Ding, Principal investigator, Shanghai Dermatology HospitalChao Ci, Principal investigator, First Affiliated Hospital of Wannan Medical CollegeWeili Pan, Principal investigator, Zhejiang Provincial People's HospitalShiqin Tao, Principal investigator, Wuxi No. 2 People's HospitalYayu Hu, Principal investigator, Taizhou University Affiliated Municipal HospitalTianhong Xu, Principal investigator, The Third People's Hospital of HangzhouZhu Shen, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077331
- Sponsor's protocol ID
- HS-10374-201
- Status last verified
- Nov 2023
- First submitted
- 24 Aug 2023
- Last updated
- 6 Dec 2023
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06077331
- Acronym / sponsor ID
- HS-10374-201
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 11 Oct 2023 (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 moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.
Detailed description
This is a 12-week, multi-center, randomized, double blind, placebo-controlled, Phase 2 study. The study duration includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned to 1 of 3 treatment arms (HS-10374 Dose 1, HS-10374 Dose 2, and placebo) in an equal ratio.
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 tablets 1mg, Drug: HS-10374 tablets 5mg, Drug: HS-10374-matched placebo tablets |
| HS-10374 Dose 2 | Experimental | Drug: HS-10374 tablets 1mg, Drug: HS-10374 tablets 5mg |
| Placebo | Active 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 (5 listed)
- Male or female subjects between the ages of 18-70 years
- 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 tablets 1mgAdministered orally QD for 12 weeks | Drug | HS-10374 Dose 1, HS-10374 Dose 2 |
| HS-10374 tablets 5mgAdministered 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 with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12
Time frame: Baseline to Week 12
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.
14 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
Number of participants with abnormalities of vital signs
Time frame: Baseline to Week 16
Number of participants with abnormalities of physical examination
Time frame: Baseline to Week 16
Incidence of clinically significant changes in electrocardiogram (ECG)
Time frame: Baseline to Week 16
Proportion of patients with sPGA 0/1 at specified time points
Time frame: Baseline to Week 16
PASI 50 response rates at specified time points
Time frame: Baseline to Week 16
PASI 75 response rates at specified time points
Time frame: Baseline to Week 16
PASI 90 response rates at specified time points
Time frame: Baseline to Week 16
PASI 100 response rates at specified time points
Time frame: Baseline to Week 16
Change from baseline in PASI scores 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
Change from baseline in DLQI scores at specified time points
Time frame: Baseline to Week 16
Ctrough
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
Jinhua Xu principal investigator
Huashan Hospital
Yangfeng Ding principal investigator
Shanghai Dermatology Hospital
Chao Ci principal investigator
First Affiliated Hospital of Wannan Medical College
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 tablets 1mg and HS-10374 tablets 5mg 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 6 Dec 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinghua Xu, PhD (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 with moderate to severe plaque psoriasis achieving PASI 75 response 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 6 Dec 2023.