PsoriasisPhase 2NCT07719530
Phase II Clinical Trial of SHR-1139 Injection in Patients With Psoriasis
A Phase 2 study testing The SHR-1139 injection in people with Psoriasis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study is a randomized, double-blind, multi-center, parallel, phase II clinical trial, aiming to evaluate the efficacy and safety of SHR-1139 injection for adult patients with psoriasis. The trial includes a 4-week screening period, a 52-week treatment period, and a 12-week safety follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- The SHR-1139 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2026to 31 Oct 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
- During the screening process, the body mass index (BMI = weight (kg) / height^2 (m^2)) was ≥ 18 kg/m^2;
- History of plaque psoriasis for more than 6 months before randomization；
- The PASI score, sPGA score, and BSA at the screening and baseline required certain requirements;
- Participants suitable for phototherapy or systemic psoriasis treatment for moderate to severe plaque psoriasis;
- Participants voluntarily signed the informed consent before any procedures related to the study, could communicate smoothly with the researchers, understood and were willing to strictly follow the requirements of this clinical study protocol to complete the study;
- Female participants with reproductive capacity or their male partners with reproductive capacity, starting from the date of signing the informed consent until 72 weeks after the last medication, had no plans for pregnancy, sperm donation, or egg donation, and voluntarily took effective contraceptive measures. The pregnancy test results of female participants during the screening period and before random administration should be negative, and must be non-lactating.
Who cannot join
- -
- The following conditions or diseases must be absent:
- The diagnosed psoriasis at the screening or baseline stage is not chronic plaque-type psoriasis;
- Has drug-induced psoriasis;
- Has other skin problems that the investigator considers would interfere with the assessment of psoriasis;
- Has concurrent other active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis, multiple sclerosis or other central demyelinating diseases, primary Sjögren's syndrome, etc.;
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- Using the following drugs or participating in clinical studies:
- During the pre-baseline period, other biological agents had been used but did not meet the washout requirements.
- Has used drugs targeting the same target before the screening;
- Has received systemic psoriasis treatment drugs within the specified period before the baseline;
- Has received topical psoriasis treatment drugs within the specified period before the baseline;
- Has received phototherapy within the specified period before the baseline;
- Has participated in any clinical study of drugs or medical devices within 3 months before the baseline or within the drug's half-life period;
- Important conditions or underlying diseases that affect safety:
- The participant has a history of lymphocytic proliferative diseases;
- The participant has had any active malignant tumor or history of malignant tumor within the previous 5 years before the screening;
- Has a history of moderate to severe congestive heart failure (NYHA cardiac function classification ≥ III) within 3 months before the screening, has experienced cardiovascular or cerebrovascular events or severe bleeding events, and the investigator considers this participant unsuitable for participating in the clinical study;
- Has had opportunistic infections or immunodeficiency diseases within the previous 6 months before the screening;
- Has had active infections requiring oral anti-infection treatment within 2 weeks before the baseline, or has had severe infections or systemic infections within 4 weeks before the baseline, requires intravenous anti-infection treatment or is hospitalized due to infection, or other chronic, recurrent, active infections that the investigator deems unsuitable for participation in this study;
- Has active tuberculosis (TB) or latent TB infection;
- Has human immunodeficiency virus antibody (HIV) positive at screening, or hepatitis C virus (HCV) antibody positive and further HCV-RNA quantitative positive; or hepatitis B surface antigen (HBsAg) positive; or HBsAg negative but HBcAb positive, and further HBV-DNA test positive; or Treponema pallidum specific antibody positive.
- Has severe, progressive, uncontrolled cardiovascular, liver, kidney, lung, gastrointestinal, hematopoietic system, endocrine, nervous system, mental system (such as depression, suicidal tendency and psychological disorders), skin and mucous membrane diseases, and other conditions that the investigator considers that the patient is not suitable to join this trial;
- Laboratory tests and/or 12-lead electrocardiogram (ECG) results are abnormal at screening:
- General situation:
- Pregnant or lactating women;
- Allergic to any component of the test drug;
- Had a history of alcohol abuse or illegal drug use within the previous year before the screening;
- Had blood donation of approximately 500 mL within the previous 8 weeks before randomization or had a blood donation plan during the study;
- Had major surgery within the previous 8 weeks before screening, or had related surgery plans during the study;
- The investigator judges that there are other situations that affect the safety and efficacy evaluation of the test 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, 1 recruiting
- Recruiting
Dermatology Hospital Hospital of Southern Medical University
Guangzhou, Guangzhou, 510091
Bin Yang
Xiaohua Wang
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Moderate to Severe Plaque Psoriasis
This study is a randomized, double-blind, multi-center, parallel, phase II clinical trial, aiming to evaluate the efficacy and safety of SHR-1139 injection for adult patients with psoriasis. The trial includes a 4-week screening period, a 52-week treatment period, and a 12-week safety follow-up period. Approximately 60 patients with psoriasis are expected to participate.
- Conditions
- Psoriasis
- Being tested
- The SHR-1139 injection, placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The SHR-1139 injectionDrug
The SHR-1139 injection
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR-1139 injection/placebo | Experimental | Not described Receives: Drug: The SHR-1139 injection; Drug: placebo |
| Treatment group B: SHR-1139 injection/placebo | Experimental | Not described Receives: Drug: The SHR-1139 injection; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who achieved a 100% improvement in the Psoriasis Area and Severity Index (PASI) score compared to the baseline by the 12th week (PASI 100).
Measured: 12th week
Secondary outcomes (4)
The proportion of participants who achieved a minimum improvement of at least 75% in PASI compared to the baseline (PASI 75) in the 12th week;
Measured: 12th week
The proportion of participants who achieved a minimum improvement of at least 90% in PASI compared to the baseline (PASI 90) in the 12th week
Measured: 12th week
The proportion of participants who achieved a sPGA response of 0 or 1 (sPGA 0/1) as assessed by the static physician in the 12th week
Measured: 12th week
The proportion of participants who achieved a sPGA response of 0 (sPGA 0) in the 12th week
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start4 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Oct 2027 (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 Guangdong Hengrui Pharmaceutical Co., LtdThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT07719530
- Sponsor's protocol ID
- SHR-1139-207
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 20 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1139 Injection in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07719530
- Acronym / sponsor ID
- SHR-1139-207
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 22 Jul 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, multi-center, parallel, phase II clinical trial, aiming to evaluate the efficacy and safety of SHR-1139 injection for adult patients with psoriasis. The trial includes a 4-week screening period, a 52-week treatment period, and a 12-week safety follow-up period. Approximately 60 patients with psoriasis are expected to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR-1139 injection/placebo | Experimental | Drug: The SHR-1139 injection, Drug: placebo |
| Treatment group B: SHR-1139 injection/placebo | Experimental | Drug: The SHR-1139 injection, Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- During the screening process, the body mass index (BMI = weight (kg) / height^2 (m^2)) was ≥ 18 kg/m^2;
- History of plaque psoriasis for more than 6 months before randomization；
- The PASI score, sPGA score, and BSA at the screening and baseline required certain requirements;
- Participants suitable for phototherapy or systemic psoriasis treatment for moderate to severe plaque psoriasis;
- Participants voluntarily signed the informed consent before any procedures related to the study, could communicate smoothly with the researchers, understood and were willing to strictly follow the requirements of this clinical study protocol to complete the study;
Key exclusion criteria (30 listed)
- -
- The diagnosed psoriasis at the screening or baseline stage is not chronic plaque-type psoriasis;
- Has drug-induced psoriasis;
- Has other skin problems that the investigator considers would interfere with the assessment of psoriasis;
- Has concurrent other active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis, multiple sclerosis or other central demyelinating diseases, primary Sjögren's syndrome, etc.;
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 |
|---|---|---|
| The SHR-1139 injectionThe SHR-1139 injection | Drug | Treatment group A: SHR-1139 injection/placebo, Treatment group B: SHR-1139 injection/placebo |
| placeboplacebo | Drug | Treatment group A: SHR-1139 injection/placebo, Treatment group B: SHR-1139 injection/placebo |
Primary outcome
The proportion of participants who achieved a 100% improvement in the Psoriasis Area and Severity Index (PASI) score compared to the baseline by the 12th week (PASI 100).
Time frame: 12th week
4 secondary outcomes
The proportion of participants who achieved a minimum improvement of at least 75% in PASI compared to the baseline (PASI 75) in the 12th week;
Time frame: 12th week
The proportion of participants who achieved a minimum improvement of at least 90% in PASI compared to the baseline (PASI 90) in the 12th week
Time frame: 12th week
The proportion of participants who achieved a sPGA response of 0 or 1 (sPGA 0/1) as assessed by the static physician in the 12th week
Time frame: 12th week
The proportion of participants who achieved a sPGA response of 0 (sPGA 0) in the 12th week
Time frame: 12th week
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 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 The SHR-1139 injection in people with 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 30 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 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 Caihong Huang (020-62726806, caihong.huang.ch57@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 who achieved a 100% improvement in the Psoriasis Area and Severity Index (PASI) score compared to the baseline by the 12th week (PASI 100). (time frame: 12th week). 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 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.