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Can a new injection clear psoriasis when other biologics fail?
NCT ID NCT07758075
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This phase II trial is testing an investigational drug called SHR-1139 in adults with plaque psoriasis who have not responded well to at least one biologic treatment. Participants will receive either SHR-1139 or a placebo via subcutaneous injection over a 52-week treatment period. The main goal is to see if the drug can achieve clear or almost clear skin, measured by a score of 0 or 1 on the sPGA scale at week 16. The study also tracks improvements in psoriasis severity scores and safety over the course of the trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-1139 injection
- What this could lead to
- If successful, this could offer a new treatment option for people with plaque psoriasis who haven't had good results from existing biologic drugs.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not hold up in larger studies. The drug may also have side effects or not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged ≥ 18 years at the time of signing the informed consent form (ICF), male or female 2. Body mass index was ≥18 kg/m ² at screening 3. A history of plaque psoriasis ≥6 months before randomization, with or without psoriatic arthritis 4. Inadequate response to at least one biologic agent administered at full dose and on a regular schedule prior to screening 5. tParticipants with plaque psoriasis deemed by the investigator suitable for continued biologic therapy 6. 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 Exclusion Criteria: 1. Diagnosis of psoriasis other than chronic plaque psoriasis at screening or baseline 2. Drug-induced psoriasis 3. Other skin conditions that, in the investigator's opinion, would interfere with psoriasis assessment 4. Concurrent other active autoimmune diseases 5. Prior exposure to drugs targeting the IL-36 receptor 6. Prior exposure to drugs targeting IL-23p19 7. Systemic treatment other than biological agents was received within 4 weeks before baseline 8. Topical treatment for psoriasis was received within two weeks before the baseline 9. Received photochemotherapy within 4 weeks before baseline, or received phototherapy within 2 weeks before baseline 10. 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 11. The participants had a previous history of lymphocytic hyperplasia 12. Participants had any history of active malignant tumors or malignant tumors within the five years prior to screening 13. 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 14. There was a history of opportunistic infection or immunodeficiency disease within 6 months prior to screening 15. 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 16. There is active tuberculosis or latent tuberculosis infection 17. 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) 18. 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 19. 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 \< 100\*109/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. 20. Pregnant or lactating female, or testing positive for human chorionic gonadotropin (hCG) 21. 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 22. There was a history of alcohol abuse or illegal drug abuse within one year prior to the screening 23. 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 24. Donate approximately 500 mL of blood within the 8 weeks prior to randomization or have a blood donation plan during the study period 25. Those who have undergone major surgery within 8 weeks prior to screening or have relevant surgical plans during the study period 26. The researchers judged that there were situations that affected the safety and efficacy evaluation of the investigational drug
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
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