A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis

Launched by GUANGDONG HENGRUI PHARMACEUTICAL CO., LTD · Mar 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called SHR-1139 for people with moderate to severe plaque psoriasis, which is a condition that causes red, scaly patches on the skin. The main goals of the study are to see how well this treatment works, how safe it is, and how it behaves in the body. This trial is currently not recruiting participants, but it will involve adults aged 18 and older who can understand the study and are willing to follow its guidelines.

To be eligible for this trial, participants need to be in good overall health and not have other skin issues that could affect the results. Women must have a negative pregnancy test and should not be breastfeeding. The study will require participants to sign a consent form and use effective contraception if they are of childbearing potential. Those with certain heart conditions, recent infections, or allergies to the treatment will not be able to participate. If you join the trial, you can expect regular check-ins and assessments to monitor your health and how you respond to the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
• • 2. Subjects voluntarily sign informed consent form (ICF) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol.
• • 3. A fertile female subject or a male subject whose partner is a fertile woman who has not had a child, has a sperm/egg donation plan for 72 weeks from the date of signing the informed consent form to the last dose, and is voluntarily using highly effective contraception (including the partner).
• • 4. Female subjects must have negative pregnancy test results during the screening period and before randomized administration, and must be non-lactating.
• Exclusion Criteria:
• • 1. There are other skin problems that researchers believe can interfere with the evaluation of psoriasis.
• • 2. A history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events or severe bleeding events occurred in the 3 months before screening, and the investigator considered this subject to be unfit for clinical study.
• • 3. Had an opportunistic infection within 6 months prior to screening.
• • 4. Allergic to the ingredients or excipients of the study drug.
• • 5. The investigator determined that there were conditions that affected the safety and efficacy evaluation of the study drug.