RecruitingNCT07879885Updated Oct 20, 2026

An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis

A Phase 2 interventional study of HS-20137 in Moderate-to-severe Plaque Psoriasis, sponsored by Hansoh BioMedical R&D Company. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Hansoh BioMedical R&D Company (part of Hansoh Pharmaceutical Group Company Limited) · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 1 year 2 months after the study started (first participant enrolled Jul 2025, registered Oct 2026).
Started Jul 2025; still recruiting 1 year 2 months later.

Updated Oct 19, 2026Newly registeredGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 390
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Moderate-to-severe Plaque Psoriasis

Keywords

Plaque Psoriasis; HS-20137; Interleukin-23

In context

Lead sponsor

Hansoh BioMedical R&D Company is the lead sponsor of 47 studies on the registry; 43 are open to participants now.

Browse Hansoh BioMedical R&D Company studies →All Hansoh Pharmaceutical Group Company Limited studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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:
1. Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before the first dose;
2. 1 weeks before the first administration, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;
3. 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;
4. 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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 390 participants (estimated)

Study arms

Experimental
HS-20137
Participants receive HS-20137 by subcutaneous injection at weeks 0, 4 and 8
Biological: HS-20137

Interventions

BiologicalHS-20137
HS-20137 200 mg injection at weeks 0, 4 and 8
Also known as: QX004N

What researchers measure

Primary outcomes

Number of Participants with Adverse Events
Adverse events will be assessed for incidence, severity, relationship to study intervention, duration, and outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 20 weeks

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 20 weeks

Study locations

1 of 1 sites recruiting

China-Japan Friendship Hospital
Beijing, Beijng 100029, China
- Siyuan Xi · Contact · ZRYHYYGCPEC@126.com · 010-84206086
Recruiting

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Mar 2027, 19 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 11, 2026
First posted: Oct 19, 2026
StartActual: Jul 31, 2025
Primary completionEst.: Mar 1, 2027
CompletionEst.: Apr 1, 2027
Last update: Oct 20, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 19, 2026

Show all 1 update

Oct 19, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07879885
Lead sponsor: Hansoh BioMedical R&D Company
Responsible party: Sponsor
First posted: Oct 19, 2026
Start date: Jul 31, 2025
Primary completion: Mar 1, 2027 (estimated)
Completion: Apr 1, 2027 (estimated)
Last update: Oct 20, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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