Moderate-to-severe Plaque PsoriasisPhase 3NCT06844799
A Study of HS-20137 in Participants with Moderate-to-severe Plaque Psoriasis
A Phase 3 study testing HS-20137 in people with Moderate-to-severe Plaque Psoriasis, run by Hansoh BioMedical R&D Company.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety 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?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2025to 30 Jun 2027
- Phase
- Phase 3
- 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≥10%; b) PASI≥12; c) sPGA≥3;
- Suitable for systemic therapy or phototherapy;
- 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
- Previous use of biological agents, or allergic reactions to known drug ingredients, or previous severe food or drug allergies;
- 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 randomization;
- 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 randomization;
- 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 randomization:
- Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before randomization;
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- 4 weeks before randomization, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;
- use of TNF-α biologics within 3 months prior to randomization;
- use of other biologics for the treatment of psoriasis within 6 months before randomization; e) Use of oral or topical proprietary Chinese medicinesor other Chinese herbal medicines that affect or may affect the evaluation of psoriasis within 4 weeks prior to randomization;
- use of lymphocyte migration regulators or B cell and T cell regulators within 3 months before randomization, or 6 months before screening, (whichever is older) use of B-cell-specific scavenging drugs;
- 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 randomization. And Other circumstances determined by the investigator to be unsuitable for further study participation.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate Efficacy and Safety of HS-20137, an Anti-IL-23 Monoclonal Antibody, in Participants with Moderate-to-severe Plaque Psoriasis
The primary objective of this study is to evaluate the efficacy and safety of HS-20137 in the treatment of participants with moderate to severe plaque psoriasis.
Read the detailed description
HS-20137 is an antibody targeting IL-23, which were recommended biologic agents for the treatment of patients with moderate-to-severe psoriasis. This is a randomized, double-blinded, placebo-controlled phase 3 study, including a 4 weeks screening period, a 52 weeks double-blinded period (placebo-control period in the first 16 weeks) and a 8 weeks follow-up period (total 60 weeks). The hypothesis is that HS-20137 will be more effective in treatment of psoriasis than placebo and well tolerated. Participants with moderate-to-severe plaque psoriasis will be included in this study and received HS-20137 200mg or placebo in week 0, 4, 8 in placebo-control period and then HS-20137 200mg every 8 or 12 weeks thereafter.
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Being tested
- HS-20137, Placebo&HS-20137
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20137Drug
HS-20137 200mg injection at week 0, 4, 8 and then every 8 or 12 weeks.
Placebo&HS-20137Drug
Placebo injection at week 0, 4, 8, and then HS-20137 200mg injection at week 16, 20, 24, and every 8 or 12 weeks thereafter
| Study group | Role | What they receive |
|---|---|---|
| HS-20137 arm1: HS-20137 200mg injection at week 0, 4, 8 and then every 8 weeks thereafter | Experimental | Not described Receives: Drug: HS-20137 |
| HS-20137 arm 2:HS-20137 200mg injection at week 0, 4, 8 and then every 12 weeks thereafter | Experimental | Not described Receives: Drug: HS-20137 |
| Placebo arm 1:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every8 week thereafter | Experimental | Not described Receives: Drug: Placebo&HS-20137 |
| Placebo arm 2:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every 12week thereafter | Experimental | Not described Receives: Drug: Placebo&HS-20137 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 90 Percent or Above
Number of participants achieving greater than or equal to 90 percent improvement in PASI at Week 16. PASI is a widely used tool for the measurement of severity of psoriasis. AND, number of participants achieving a physician global assessment (PGA) (0 [none] to 4 [severe]) of cleared or minimal at Week 16
Measured: At week 16
Physician Global Assessment (PGA) score of 0/1
number of participants achieving a physician global assessment (PGA) (0 [none] to 4 [severe]) of cleared or minimal at Week 16. The PGA is 5-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 4 (severe)
Measured: At week 16
Secondary outcomes (6)
PASI 90 response rate at other visit time points
Measured: up to 60 weeks
PASI scores and changes from baseline at each visit time point
Measured: up to 60 weeks
PASI 75 response rate and PASI 100 response rate at each visit time point
Measured: up to 60 weeks
sPGA 0/1 response rate at other visit time points
Measured: during the study period except 16 weeks
sPGA 0 response rate at each visit time point
Measured: up to 60 weeks
BSA scores and changes from baseline at each visit time point
body surface area(BSA):0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease
Measured: up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start10 Jun 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 720 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
- NCT06844799
- Sponsor's protocol ID
- HS-20137-301
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 25 Feb 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate Efficacy and Safety of HS-20137, an Anti-IL-23 Monoclonal Antibody, in Participants with Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06844799
- Acronym / sponsor ID
- HS-20137-301
- Conditions
- Moderate-to-severe Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Feb 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.
The primary objective of this study is to evaluate the efficacy and safety of HS-20137 in the treatment of participants with moderate to severe plaque psoriasis.
Detailed description
HS-20137 is an antibody targeting IL-23, which were recommended biologic agents for the treatment of patients with moderate-to-severe psoriasis. This is a randomized, double-blinded, placebo-controlled phase 3 study, including a 4 weeks screening period, a 52 weeks double-blinded period (placebo-control period in the first 16 weeks) and a 8 weeks follow-up period (total 60 weeks). The hypothesis is that HS-20137 will be more effective in treatment of psoriasis than placebo and well tolerated. Participants with moderate-to-severe plaque psoriasis will be included in this study and received HS-20137 200mg or placebo in week 0, 4, 8 in placebo-control period and then HS-20137 200mg every 8 or 12 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-20137 arm1: HS-20137 200mg injection at week 0, 4, 8 and then every 8 weeks thereafter | Experimental | Drug: HS-20137 |
| HS-20137 arm 2:HS-20137 200mg injection at week 0, 4, 8 and then every 12 weeks thereafter | Experimental | Drug: HS-20137 |
| Placebo arm 1:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every8 week thereafter | Experimental | Drug: Placebo&HS-20137 |
| Placebo arm 2:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every 12week thereafter | Experimental | Drug: Placebo&HS-20137 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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≥10%; b) PASI≥12; c) sPGA≥3;
- Suitable for systemic therapy or phototherapy;
- 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 (11 listed)
- Previous use of biological agents, or allergic reactions to known drug ingredients, or previous severe food or drug allergies;
- 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 randomization;
- 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 randomization;
- 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 randomization:
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-20137HS-20137 200mg injection at week 0, 4, 8 and then every 8 or 12 weeks. | Drug | HS-20137 arm 2:HS-20137 200mg injection at week 0, 4, 8 and then every 12 weeks thereafter, HS-20137 arm1: HS-20137 200mg injection at week 0, 4, 8 and then every 8 weeks thereafter |
| Placebo&HS-20137Placebo injection at week 0, 4, 8, and then HS-20137 200mg injection at week 16, 20, 24, and every 8 or 12 weeks thereafter | Drug | Placebo arm 1:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every8 week thereafter, Placebo arm 2:Placebo at week 0,4,8, and HS-20137 200mg at week 16,20,24 and every 12week thereafter |
Primary outcome
Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 90 Percent or Above
Time frame: At week 16
Number of participants achieving greater than or equal to 90 percent improvement in PASI at Week 16. PASI is a widely used tool for the measurement of severity of psoriasis. AND, number of participants achieving a physician global assessment (PGA) (0 [none] to 4 [severe]) of cleared or minimal at Week 16
Physician Global Assessment (PGA) score of 0/1
Time frame: At week 16
number of participants achieving a physician global assessment (PGA) (0 [none] to 4 [severe]) of cleared or minimal at Week 16. The PGA is 5-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 4 (severe)
6 secondary outcomes
PASI 90 response rate at other visit time points
Time frame: up to 60 weeks
PASI scores and changes from baseline at each visit time point
Time frame: up to 60 weeks
PASI 75 response rate and PASI 100 response rate at each visit time point
Time frame: up to 60 weeks
sPGA 0/1 response rate at other visit time points
Time frame: during the study period except 16 weeks
sPGA 0 response rate at each visit time point
Time frame: up to 60 weeks
BSA scores and changes from baseline at each visit time point
Time frame: up to 60 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 25 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-20137 in people with Moderate-to-severe Plaque Psoriasis, run by Hansoh BioMedical R&D Company.
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 11 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 90 Percent or Above (time frame: At 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 25 Feb 2025.