A Phase 2 interventional study of SHR-1139 and SHR-1139 and SHR-1139 pleacebo in Plaque Psoriasis, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2, Interventional, and Treatment
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 50 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 59 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
The following situations occur in laboratory tests and/or 12-lead (ECG) during screening:
(AST) or ALT is three times or more greater than the value (ULN).
Total > 1.5 times ULN; Serum creatinine > 1.5 times ULN; The 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; \< 1.5 *109/L; count \< 100*109/L; The 12-lead ECG examination indicated abnormalities that might affect the safety of the participants, including but not limited to acute myocardial ischemia, myocardial infarction, and severe arrhythmia.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SHR-1139
Drug: SHR-1139 and SHR-1139 pleacebo
Subcutaneous injection of SHR-1139
Subcutaneous injection of SHR-1139 and SHR-1139 pleacebo
The proportion of participants with a sPGA response of 0 or 1 at week 16.
Time frame: at week 16
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SHR-1139
Guangdong Hengrui Pharmaceutical Co., Ltd →