Moderate-to-severe Plaque PsoriasisPhase 2NCT07879885
An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing HS-20137 in people with Moderate-to-severe Plaque Psoriasis, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of HS-20137 in the treatment of 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
- Moderate-to-severe Plaque Psoriasis
- What is being tested?
- HS-20137
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to 1 Apr 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
- Adults aged 18 and above, male or female;
- Diagnosed plaque psoriasis for at least 6 months before randomization, with or without psoriatic arthritis;
- During screening and randomization, the severity of plaque psoriasis was moderate to severe, and the following conditions should be met: a) BSA≥3%; b) PASI≥3;
- Voluntarily participate in the research, have the ability and willingness to complete the research according to the research protocol, and sign the informed consent.
Who cannot join
- History of an allergic reaction following prior use of a biologic agent, allergy to known drug components, or a history of severe food or drug allergy;
- Confirmation of other types of psoriasis, including but not limited to guttiform psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced exacerbation of psoriasis (including beta-blockers, non-steroidal anti-inflammatory drugs, antimalarial drugs, interferon, calcium channel blockers, or lithium induced psoriasis) from the screening period to the time before the first dose;
- Other skin lesions, chronic inflammatory diseases or autoimmune diseases, including but not limited to systemic lupus erythematosus, Sjogren's syndrome, skin sclerosis, etc., assessed by the investigator and other factors that may affect the efficacy evaluation or assessed by other researchers before the first dose;
- Primary treatment failure occurred with previous use of similar investigatory drugs (including marketed ulinumab, gusecciumab, Tiricizumab, Lisenciumab, and IL-23 target investigatory drugs under development) (the minimum treatment standard was not reached 12 weeks after the first treatment);
- Use of the following drugs before the first dose:
- Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before the first dose;
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- 1 weeks before the first administration, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;
- Prior to the first dose, use of other biologics for the treatment of psoriasis (including but not limited to TNF α inhibitors, secukinumab, ixekizumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and investigational IL 23 targeting drugs) without meeting the protocol required time interval for re administration of the original biologic;
- use of lymphocyte migration regulators or B cell and T cell regulators (including but not limited to abatacept, telitacicept, etc.), within 3 months before dose, or 6 months before screening, (whichever is older) use of B-cell-specific scavenging drugs (including but not limited to rituximab, inebilizumab, etc.);
- A history of chronic recurrent infection, or opportunistic infection in the 6 months prior to screening, or hospitalization for a serious infectious disease or intravenous antibiotic use in the 2 months prior to randomization, with a confirmed or suspected illness in the 1 week prior to the first dose. And Other circumstances determined by the investigator to be unsuitable for further study participation.
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, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijng, 100029
Siyuan Xi, 010-84206086, ZRYHYYGCPEC@126.com
About this study
Official title: An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of HS-20137, an Anti-IL-23 Monoclonal Antibody, in Participants With Moderate-to-severe Plaque Psoriasis
The purpose of this study is to evaluate the safety and efficacy of HS-20137 in the treatment of participants with moderate-to-severe plaque psoriasis
Read the detailed description
HS-20137 is an antibody targeting interleukin-23 (IL-23), a key cytokine involved in the pathogenesis of psoriasis. IL-23-targeting biologic agents are recommended for the treatment of patients with moderate-to-severe psoriasis. This is an open-label, Phase 2, single-arm interventional study, including a 4-week screening period, a 16-week treatment period and a 4-week follow-up period (total 24 weeks). Participants with moderate-to-severe plaque psoriasis will be enrolled in this study and will receive HS-20137 200 mg at weeks 0, 4 and 8. The primary objective is to evaluate the safety and tolerability of HS-20137. Secondary objectives are to evaluate the efficacy and immunogenicity of HS-20137
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Being tested
- HS-20137
- Keywords
- Plaque Psoriasis; HS-20137; Interleukin-23
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20137Biological
Also called QX004N
HS-20137 200 mg injection at weeks 0, 4 and 8
| Study group | Role | What they receive |
|---|---|---|
| HS-20137 | Experimental | Participants receive HS-20137 by subcutaneous injection at weeks 0, 4 and 8 Receives: Biological: HS-20137 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Adverse events will be assessed for incidence, severity, relationship to study intervention, duration, and outcome.
Measured: up to 20 weeks
Changes From Baseline in Clinical Laboratory Test Results
Changes from baseline in protocol-specified clinical laboratory test results following administration of HS-20137 will be assessed.
Measured: Frame: up to 20 weeks
Changes From Baseline in Physical Examination Findings
Changes from baseline in physical examination findings following administration of HS-20137 will be assessed.
Measured: up to 20 weeks
Changes From Baseline in Vital Signs
Changes from baseline in protocol-specified vital signs following administration of HS-20137 will be assessed.
Measured: up to 20 weeks
Incidence of Clinically Significant Electrocardiogram (ECG) Abnormalities
The incidence of clinically significant electrocardiogram (ECG) abnormalities following administration of HS-20137 will be assessed.
Measured: up to 20 weeks
Secondary outcomes (5)
PASI 50, PASI 75, PASI 90, and PASI 100 Response Rates at Each Visit Time Point
The Psoriasis Area and Severity Index (PASI) is a scoring system used to assess the severity of psoriasis based on lesion severity and area of involvement. PASI 50, PASI 75, PASI 90, and PASI 100 response rates are defined as the percentages of participants achieving at least 50%, 75%, 90%, and 100% reduction, respectively, in PASI score from baseline. These response rates will be assessed at each visit time point.
Measured: up to 20 weeks
PASI Scores and Changes From Baseline at Each Visit Time Point
The Psoriasis Area and Severity Index (PASI) score and changes from baseline in PASI score will be assessed at each visit time point.
Measured: up to 20 weeks
sPGA 0/1 Response Rate at Each Visit Time Point
The static Physician's Global Assessment (sPGA) is a 5-point scale ranging from 0 (clear) to 4 (severe) used to assess the overall severity of psoriasis lesions. The sPGA 0/1 response rate is defined as the percentage of participants achieving an sPGA score of 0 (clear) or 1 (almost clear) at each visit time point.
Measured: up to 20 weeks
sPGA 0 Response Rate at Each Visit Time Point
The static Physician's Global Assessment (sPGA) is a 5-point scale ranging from 0 (clear) to 4 (severe) used to assess the overall severity of psoriasis lesions. The sPGA 0 response rate is defined as the percentage of participants achieving an sPGA score of 0 (clear) at each visit time point.
Measured: up to 20 weeks
BSA Scores and Changes From Baseline at Each Visit Time Point
The percentage of body surface area (BSA) affected by psoriasis and changes from baseline in BSA will be assessed at each visit time point.
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start31 Jul 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 390 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
- NCT07879885
- Sponsor's protocol ID
- HS-20137-202
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of HS-20137, an Anti-IL-23 Monoclonal Antibody, in Participants With Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07879885
- Acronym / sponsor ID
- HS-20137-202
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Keywords
- Plaque Psoriasis; HS-20137; Interleukin-23
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 19 Oct 2026 (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 purpose of this study is to evaluate the safety and efficacy of HS-20137 in the treatment of participants with moderate-to-severe plaque psoriasis
Detailed description
HS-20137 is an antibody targeting interleukin-23 (IL-23), a key cytokine involved in the pathogenesis of psoriasis. IL-23-targeting biologic agents are recommended for the treatment of patients with moderate-to-severe psoriasis. This is an open-label, Phase 2, single-arm interventional study, including a 4-week screening period, a 16-week treatment period and a 4-week follow-up period (total 24 weeks). Participants with moderate-to-severe plaque psoriasis will be enrolled in this study and will receive HS-20137 200 mg at weeks 0, 4 and 8. The primary objective is to evaluate the safety and tolerability of HS-20137. Secondary objectives are to evaluate the efficacy and immunogenicity of HS-20137
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-20137 | Experimental | Biological: HS-20137Participants receive HS-20137 by subcutaneous injection at weeks 0, 4 and 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 and above, male or female;
- Diagnosed plaque psoriasis for at least 6 months before randomization, with or without psoriatic arthritis;
- During screening and randomization, the severity of plaque psoriasis was moderate to severe, and the following conditions should be met: a) BSA≥3%; b) PASI≥3;
- Voluntarily participate in the research, have the ability and willingness to complete the research according to the research protocol, and sign the informed consent.
Key exclusion criteria (10 listed)
- History of an allergic reaction following prior use of a biologic agent, allergy to known drug components, or a history of severe food or drug allergy;
- Confirmation of other types of psoriasis, including but not limited to guttiform psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced exacerbation of psoriasis (including beta-blockers, non-steroidal anti-inflammatory drugs, antimalarial drugs, interferon, calcium channel blockers, or lithium induced psoriasis) from the screening period to the time before the first dose;
- Other skin lesions, chronic inflammatory diseases or autoimmune diseases, including but not limited to systemic lupus erythematosus, Sjogren's syndrome, skin sclerosis, etc., assessed by the investigator and other factors that may affect the efficacy evaluation or assessed by other researchers before the first dose;
- Primary treatment failure occurred with previous use of similar investigatory drugs (including marketed ulinumab, gusecciumab, Tiricizumab, Lisenciumab, and IL-23 target investigatory drugs under development) (the minimum treatment standard was not reached 12 weeks after the first treatment);
- Use of the following drugs before the first dose:
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-20137Also: QX004NHS-20137 200 mg injection at weeks 0, 4 and 8 | Biological | HS-20137 |
Primary outcome
Number of Participants with Adverse Events
Time frame: up to 20 weeks
Adverse events will be assessed for incidence, severity, relationship to study intervention, duration, and outcome.
Changes From Baseline in Clinical Laboratory Test Results
Time frame: Frame: up to 20 weeks
Changes from baseline in protocol-specified clinical laboratory test results following administration of HS-20137 will be assessed.
Changes From Baseline in Physical Examination Findings
Time frame: up to 20 weeks
Changes from baseline in physical examination findings following administration of HS-20137 will be assessed.
Changes From Baseline in Vital Signs
Time frame: up to 20 weeks
Changes from baseline in protocol-specified vital signs following administration of HS-20137 will be assessed.
Incidence of Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: up to 20 weeks
The incidence of clinically significant electrocardiogram (ECG) abnormalities following administration of HS-20137 will be assessed.
5 secondary outcomes
PASI 50, PASI 75, PASI 90, and PASI 100 Response Rates at Each Visit Time Point
Time frame: up to 20 weeks
PASI Scores and Changes From Baseline at Each Visit Time Point
Time frame: up to 20 weeks
sPGA 0/1 Response Rate at Each Visit Time Point
Time frame: up to 20 weeks
sPGA 0 Response Rate at Each Visit Time Point
Time frame: up to 20 weeks
BSA Scores and Changes From Baseline at Each Visit Time Point
Time frame: up to 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 20 Oct 2026.
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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.
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-20137 in people with Moderate-to-severe Plaque 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 10 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: up to 20 weeks). The study lists 5 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 20 Oct 2026.