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Can an experimental injection clear stubborn psoriasis? a new trial aims to find out.

NCT ID NCT07719530

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether the experimental drug SHR-1139 can improve skin clearance in adults with moderate to severe plaque psoriasis. About 60 participants will receive either SHR-1139 or a placebo over 52 weeks. The main goal is to see how many achieve complete skin clearance by week 12.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called SHR-1139
What this could lead to
If successful, SHR-1139 could offer a new treatment option for people with moderate to severe plaque psoriasis, potentially leading to clearer skin.
What could go wrong
This is an early phase 2 trial with only 60 participants, so results may not apply to everyone. The drug may cause side effects or fail to outperform placebo.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. During the screening process, the body mass index (BMI = weight (kg) / height\^2 (m\^2)) was ≥ 18 kg/m\^2; 2. History of plaque psoriasis for more than 6 months before randomization; 3. The PASI score, sPGA score, and BSA at the screening and baseline required certain requirements; 4. Participants suitable for phototherapy or systemic psoriasis treatment for moderate to severe plaque psoriasis; 5. 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; 6. 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. Exclusion Criteria: \- The following conditions or diseases must be absent: 1. The diagnosed psoriasis at the screening or baseline stage is not chronic plaque-type psoriasis; 2. Has drug-induced psoriasis; 3. Has other skin problems that the investigator considers would interfere with the assessment of psoriasis; 4. 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.; Using the following drugs or participating in clinical studies: 1. During the pre-baseline period, other biological agents had been used but did not meet the washout requirements. 2. Has used drugs targeting the same target before the screening; 3. Has received systemic psoriasis treatment drugs within the specified period before the baseline; 4. Has received topical psoriasis treatment drugs within the specified period before the baseline; 5. Has received phototherapy within the specified period before the baseline; 6. 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: 1. The participant has a history of lymphocytic proliferative diseases; 2. The participant has had any active malignant tumor or history of malignant tumor within the previous 5 years before the screening; 3. 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; 4. Has had opportunistic infections or immunodeficiency diseases within the previous 6 months before the screening; 5. 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; 6. Has active tuberculosis (TB) or latent TB infection; 7. 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. 8. 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; 9. Laboratory tests and/or 12-lead electrocardiogram (ECG) results are abnormal at screening: General situation: 1. Pregnant or lactating women; 2. Allergic to any component of the test drug; 3. Had a history of alcohol abuse or illegal drug use within the previous year before the screening; 4. Had blood donation of approximately 500 mL within the previous 8 weeks before randomization or had a blood donation plan during the study; 5. Had major surgery within the previous 8 weeks before screening, or had related surgery plans during the study; 6. The investigator judges that there are other situations that affect the safety and efficacy evaluation of the test 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Dermatology Hospital Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangzhou, 510091, China

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Other studies related to the condition(s) this trial covers.