Plaque PsoriasisPhase 2NCT07758075
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Plaque Psoriasis
A Phase 2 study testing SHR-1139 and SHR-1139 and SHR-1139 pleacebo in people with Plaque Psoriasis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study is a randomized, double-blind, multicenter, dose-parallel-controlled phase II clinical trial. The study consists of three stages: a 4-week screening period, a 52-week treatment period, and a 12-week follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- SHR-1139 and SHR-1139 and SHR-1139 pleacebo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to May 2028
- 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
- Aged ≥ 18 years at the time of signing the informed consent form (ICF), male or female
- Body mass index was ≥18 kg/m ² at screening
- A history of plaque psoriasis ≥6 months before randomization, with or without psoriatic arthritis
- Inadequate response to at least one biologic agent administered at full dose and on a regular schedule prior to screening
- tParticipants with plaque psoriasis deemed by the investigator suitable for continued biologic therapy
- Participants voluntarily sign informed consent before the start of any procedures related to the study, able to communicate smoothly with the investigator, understand and comply with the study protocol requirements
Who cannot join
- Diagnosis of psoriasis other than chronic plaque psoriasis at screening or baseline
- Drug-induced psoriasis
- Other skin conditions that, in the investigator's opinion, would interfere with psoriasis assessment
- Concurrent other active autoimmune diseases
- Prior exposure to drugs targeting the IL-36 receptor
- Prior exposure to drugs targeting IL-23p19
Show all 29Show fewer
- Systemic treatment other than biological agents was received within 4 weeks before baseline
- Topical treatment for psoriasis was received within two weeks before the baseline
- Received photochemotherapy within 4 weeks before baseline, or received phototherapy within 2 weeks before baseline
- Have participated in any clinical study of a drug or medical device within 3 months prior to baseline or within 5 half-lives of the drug
- The participants had a previous history of lymphocytic hyperplasia
- Participants had any history of active malignant tumors or malignant tumors within the five years prior to screening
- Participants with a history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events, or severe bleeding events within 3 months prior to screening were considered unsuitable for clinical research by the researchers
- There was a history of opportunistic infection or immunodeficiency disease within 6 months prior to screening
- If there was an active infection within 2 weeks before baseline requiring oral anti-infection treatment, or if there was a severe infection or systemic infection within 4 weeks before baseline requiring intravenous anti-infection treatment or hospitalization due to infection, or other chronic, recurrent, and active infections that the researcher judged as unsuitable for participation in this study
- There is active tuberculosis or latent tuberculosis infection
- Positive human immunodeficiency virus antibody (HIV), or positive hepatitis C virus (HCV) antibody test and positive quantitative hepatitis C ribonucleic acid (HCV-RNA) during screening; Or positive for hepatitis B surface antigen (HBsAg)
- Patients with severe, progressive, uncontrolled cardiovascular and cerebrovascular, liver, kidney, lung, gastrointestinal, hematopoietic system, endocrine, nervous system, mental system, skin and mucous membrane diseases, etc., as well as other conditions that researchers consider unsuitable for participation in this trial
- The following situations occur in laboratory tests and/or 12-lead electrocardiogram (ECG) during screening:
- Aspartate aminotransferase (AST) or ALT is three times or more greater than the upper limit of the normal value (ULN).
- Total bilirubin > 1.5 times ULN; Serum creatinine > 1.5 times ULN; The hemoglobin level was less than 85.0 g/L for male participants and less than 80.0 g/L for female participants.
- White blood cell count < 3.0 109/L; Neutrophil count < 1.5 109/L; Platelet count < 100109/L; The 12-lead ECG examination indicated clinically significant abnormalities that might affect the safety of the participants, including but not limited to acute myocardial ischemia, myocardial infarction, and severe arrhythmia.
- Pregnant or lactating female, or testing positive for human chorionic gonadotropin (hCG)
- Allergic to the investigational drug (including SHR-1139 injection and placebo) or any component in the investigational drug; Or those with a clear history of allergy to monoclonal antibodies or drugs targeting the same action; Or those with a history of severe drug allergies
- There was a history of alcohol abuse or illegal drug abuse within one year prior to the screening
- Those who received a live attenuated vaccine within 12 weeks before randomization, or intended to receive a live attenuated vaccine during the study period, or participated in a vaccine clinical trial within 12 weeks before randomization
- Donate approximately 500 mL of blood within the 8 weeks prior to randomization or have a blood donation plan during the study period
- Those who have undergone major surgery within 8 weeks prior to screening or have relevant surgical plans during the study period
- The researchers judged that there were situations that affected the safety and efficacy evaluation of the investigational drug
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
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Xiang Chen
Yehong Kuang
About this study
Official title: A Multicenter, Randomized, Double-blind, Dose-parallel-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Plaque Psoriasis Who Have Poor Response to Biological Agents
This study is a randomized, double-blind, multicenter, dose-parallel-controlled phase II clinical trial.
The study consists of three stages: a 4-week screening period, a 52-week treatment period, and a 12-week follow-up period. For the qualified participants screened, using body weight (≥90 kg or < 90 kg) and whether participants had a poor response to IL-12/23p40 inhibitors in the past (yes vs no) as stratification factors, they were randomly assigned to two groups in a 1:1 ratio: Group 1 and Group 2. The evaluation of the primary study endpoint, some secondary study endpoints and some other endpoints was completed at 16 weeks.
Participants who complete the 52nd week assessment will enter a 12-week safe follow-up period until the end of the study.
- Conditions
- Plaque Psoriasis
- Being tested
- SHR-1139, SHR-1139 and SHR-1139 pleacebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1139Drug
Subcutaneous injection of SHR-1139
SHR-1139 and SHR-1139 pleaceboDrug
Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Subcutaneous injection of SHR-1139 | Experimental | Not described Receives: Drug: SHR-1139 |
| Group 2: Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo | Experimental | Not described Receives: Drug: SHR-1139 and SHR-1139 pleacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with a sPGA response of 0 or 1 at week 16.
Measured: at week 16
Secondary outcomes (32)
The proportion of participants whose PASI score improved by at least 90% compared to the baseline in week 16 (reaching PASI 90)
Measured: week 16
The proportion of participants whose PASI score improved by at least 75% compared to the baseline in week 16 (reaching PASI 75)
Measured: week 16
The proportion of participants whose PASI score improved by at least 100% compared to the baseline in week 16 (reaching PASI 100)
Measured: week 16
The proportion of participants with a 0 sPGA response in week 16
Measured: week 16
The proportion of participants with a sPGA response of 0 or 1 at all other visits every four weeks, up to 64 weeks
Measured: up to 64 weeks
The proportion of participants reaching PASI 90 at all other visits every four weeks, up to 64 weeks
Measured: up to 64 weeks
The proportion of participants reaching PASI 75 at all other visits every four weeks, up to 64 weeks
Measured: up to 64 weeks
The proportion of participants reaching PASI 100 at all other visits every four weeks, up to 64 weeks
Measured: up to 64 weeks
The proportion of participants with a sPGA response of 0 at all other visits every four weeks, up to 64 weeks
Measured: up to 64 weeks
The change values and percentage of change in PASI scores at each visiting point every four weeks relative to the baseline, up to 64 weeks
Measured: up to 64 weeks
Among the participants with a baseline pruritus score (NRS) of ≥4, the proportion of those with an improvement of ≥4 at week 16
Measured: week 16
The proportion of participants who achieved a dermatological quality of life index (DLQI) of 0 or 1 at week 16
Measured: week 16
The change in NRS scores at each visit point every four weeks relative to the baseline and the percentage of change, up to 64 weeks
Measured: up to 64 weeks
The change values and percentage changes of DLQI scores at each visiting point every four weeks relative to the baseline, up to 64 weeks
Measured: up to 64 weeks
The time from randomization to 16 weeks when the sPGA response first reached 0 or 1
Measured: 16 weeks
The time from randomization to 16 weeks when the sPGA response first reached 0
Measured: 16 weeks
The time when participants first reached PASI 75 from randomization to 16 weeks
Measured: 16 weeks
The time when participants first reached PASI 90 from randomization to 16 weeks
Measured: 16 weeks
The proportion of participants who achieved an sPGA response of 0 or 1 in week 16 and still achieved an sPGA response of 0 or 1 in week 26
Measured: week 26
The proportion of participants who achieved PASI 75 in week 16 and still reached PASI 75 in Week 26
Measured: Week 26
The proportion of participants who achieved PASI 90 in week 16 and still reached PASI 90 in week 26
Measured: week 26
The proportion of participants who achieved an sPGA response of 0 or 1 in week 16 and still achieved an sPGA response of 0 or 1 in week 52
Measured: week 52
The proportion of participants who achieved PASI 75 in week 16 and still reached it in Week 52
Measured: Week 52
The proportion of participants who achieved PASI 90 in week 16 and still reached it in week 52
Measured: week 52
The proportion of participants who achieved an sPGA response of 0 or 1 in week 26 and still achieved an sPGA response of 0 or 1 in week 52
Measured: week 52
The proportion of participants who achieved PASI 75 in week 26 and still reached it in Week 52
Measured: Week 52
The proportion of participants who achieved PASI 90 in week 26 and still reached it in week 52
Measured: week 52
Safety and tolerability: Adverse events, up to 68 weeks
Measured: up to 68 weeks
PK: The concentration of SHR-1139 in serum at week0,1,4,8,16,26,28,44,64
Measured: at week0,1,4,8,16,26,28,44,64
Immunogenicity: The positive incidence rate of ADA at week 0,8,16,26,44,64
Measured: at week 0,8,16,26,44,64
Immunogenicity: The positive occurrence time of ADA at week 0,8,16,26,44,64
Measured: at week 0,8,16,26,44,64
Biomarker: Inhibition rate of IFNγ activation and release in whole blood at each time point after administration at week0,1,4,8,16,26,28,44,64
Measured: at week0,1,4,8,16,26,28,44,64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758075
- Sponsor's protocol ID
- SHR-1139-204
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Dose-parallel-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Plaque Psoriasis Who Have Poor Response to Biological Agents
- ClinicalTrials.gov ID
- NCT07758075
- Acronym / sponsor ID
- SHR-1139-204
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 11 Aug 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.
This study is a randomized, double-blind, multicenter, dose-parallel-controlled phase II clinical trial.
The study consists of three stages: a 4-week screening period, a 52-week treatment period, and a 12-week follow-up period. For the qualified participants screened, using body weight (≥90 kg or < 90 kg) and whether participants had a poor response to IL-12/23p40 inhibitors in the past (yes vs no) as stratification factors, they were randomly assigned to two groups in a 1:1 ratio: Group 1 and Group 2. The evaluation of the primary study endpoint, some secondary study endpoints and some other endpoints was completed at 16 weeks.
Participants who complete the 52nd week assessment will enter a 12-week safe follow-up period until the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Subcutaneous injection of SHR-1139 | Experimental | Drug: SHR-1139 |
| Group 2: Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo | Experimental | Drug: SHR-1139 and SHR-1139 pleacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years at the time of signing the informed consent form (ICF), male or female
- Body mass index was ≥18 kg/m ² at screening
- A history of plaque psoriasis ≥6 months before randomization, with or without psoriatic arthritis
- Inadequate response to at least one biologic agent administered at full dose and on a regular schedule prior to screening
- tParticipants with plaque psoriasis deemed by the investigator suitable for continued biologic therapy
Key exclusion criteria (29 listed)
- Diagnosis of psoriasis other than chronic plaque psoriasis at screening or baseline
- Drug-induced psoriasis
- Other skin conditions that, in the investigator's opinion, would interfere with psoriasis assessment
- Concurrent other active autoimmune diseases
- Prior exposure to drugs targeting the IL-36 receptor
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 |
|---|---|---|
| SHR-1139Subcutaneous injection of SHR-1139 | Drug | Group 1: Subcutaneous injection of SHR-1139 |
| SHR-1139 and SHR-1139 pleaceboSubcutaneous injection of SHR-1139 and SHR-1139 pleacebo | Drug | Group 2: Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo |
Primary outcome
The proportion of participants with a sPGA response of 0 or 1 at week 16.
Time frame: at week 16
32 secondary outcomes
The proportion of participants whose PASI score improved by at least 90% compared to the baseline in week 16 (reaching PASI 90)
Time frame: week 16
The proportion of participants whose PASI score improved by at least 75% compared to the baseline in week 16 (reaching PASI 75)
Time frame: week 16
The proportion of participants whose PASI score improved by at least 100% compared to the baseline in week 16 (reaching PASI 100)
Time frame: week 16
The proportion of participants with a 0 sPGA response in week 16
Time frame: week 16
The proportion of participants with a sPGA response of 0 or 1 at all other visits every four weeks, up to 64 weeks
Time frame: up to 64 weeks
The proportion of participants reaching PASI 90 at all other visits every four weeks, up to 64 weeks
Time frame: up to 64 weeks
The proportion of participants reaching PASI 75 at all other visits every four weeks, up to 64 weeks
Time frame: up to 64 weeks
The proportion of participants reaching PASI 100 at all other visits every four weeks, up to 64 weeks
Time frame: up to 64 weeks
The proportion of participants with a sPGA response of 0 at all other visits every four weeks, up to 64 weeks
Time frame: up to 64 weeks
The change values and percentage of change in PASI scores at each visiting point every four weeks relative to the baseline, up to 64 weeks
Time frame: up to 64 weeks
Among the participants with a baseline pruritus score (NRS) of ≥4, the proportion of those with an improvement of ≥4 at week 16
Time frame: week 16
The proportion of participants who achieved a dermatological quality of life index (DLQI) of 0 or 1 at week 16
Time frame: week 16
The change in NRS scores at each visit point every four weeks relative to the baseline and the percentage of change, up to 64 weeks
Time frame: up to 64 weeks
The change values and percentage changes of DLQI scores at each visiting point every four weeks relative to the baseline, up to 64 weeks
Time frame: up to 64 weeks
The time from randomization to 16 weeks when the sPGA response first reached 0 or 1
Time frame: 16 weeks
The time from randomization to 16 weeks when the sPGA response first reached 0
Time frame: 16 weeks
The time when participants first reached PASI 75 from randomization to 16 weeks
Time frame: 16 weeks
The time when participants first reached PASI 90 from randomization to 16 weeks
Time frame: 16 weeks
The proportion of participants who achieved an sPGA response of 0 or 1 in week 16 and still achieved an sPGA response of 0 or 1 in week 26
Time frame: week 26
The proportion of participants who achieved PASI 75 in week 16 and still reached PASI 75 in Week 26
Time frame: Week 26
The proportion of participants who achieved PASI 90 in week 16 and still reached PASI 90 in week 26
Time frame: week 26
The proportion of participants who achieved an sPGA response of 0 or 1 in week 16 and still achieved an sPGA response of 0 or 1 in week 52
Time frame: week 52
The proportion of participants who achieved PASI 75 in week 16 and still reached it in Week 52
Time frame: Week 52
The proportion of participants who achieved PASI 90 in week 16 and still reached it in week 52
Time frame: week 52
The proportion of participants who achieved an sPGA response of 0 or 1 in week 26 and still achieved an sPGA response of 0 or 1 in week 52
Time frame: week 52
The proportion of participants who achieved PASI 75 in week 26 and still reached it in Week 52
Time frame: Week 52
The proportion of participants who achieved PASI 90 in week 26 and still reached it in week 52
Time frame: week 52
Safety and tolerability: Adverse events, up to 68 weeks
Time frame: up to 68 weeks
PK: The concentration of SHR-1139 in serum at week0,1,4,8,16,26,28,44,64
Time frame: at week0,1,4,8,16,26,28,44,64
Immunogenicity: The positive incidence rate of ADA at week 0,8,16,26,44,64
Time frame: at week 0,8,16,26,44,64
Immunogenicity: The positive occurrence time of ADA at week 0,8,16,26,44,64
Time frame: at week 0,8,16,26,44,64
Biomarker: Inhibition rate of IFNγ activation and release in whole blood at each time point after administration at week0,1,4,8,16,26,28,44,64
Time frame: at week0,1,4,8,16,26,28,44,64
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 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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 SHR-1139 and SHR-1139 and SHR-1139 pleacebo in people with Plaque Psoriasis, run by Guangdong Hengrui Pharmaceutical Co., Ltd 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 6 inclusion and 29 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 11 Aug 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?
Contact Yijia Xu (0518-82342973, yijia.xu.yx309@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with a sPGA response of 0 or 1 at week 16. (time frame: at week 16). 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 11 Aug 2026.