Clinical trial for Psoriasis
Official title Phase II Clinical Trial of SHR-1139 Injection in Patients With Psoriasis
ClinicalTrials.gov ID: NCT07719530
What this study is testing
What is The SHR-1139 injection?
The SHR-1139 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- \- 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...
- During the pre-baseline period, other biological agents had been used but did not meet the washout requirements.
See the full eligibility criteria
- 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...
- 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...
- \- 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...
- 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...
- 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...
- 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...
- Has severe, progressive, uncontrolled cardiovascular, liver, kidney, lung, gastrointestinal, hematopoietic system, endocrine, nervous system, mental system (such as depression, suicidal tendency and psychological...
- 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 how well it works evaluation of the test drug.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.