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Clinical Trials in China / NCT06875934
Active, not recruiting Phase 2

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

NCT06875934 · tracked via the Priya Life Science China tracker
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Phase
Phase 2
Started
2025-03-28
Last updated
2025-07-14

Condition(s) studied

Moderate to Severe Plaque Psoriasis

Investigational drug(s) / intervention(s)

SHR-1139 InjectionSHR-1139 Injection Placebo

SHR-1139 Injection: SHR-1139 injection.

SHR-1139 Injection Placebo: SHR-1139 injection placebo.

Study summary

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 injection in patients with moderate to severe plaque psoriasis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Dermatology Hospital Shanghai Shanghai Municipality

More Guangdong Hengrui Pharmaceutical Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06875934 on ClinicalTrials.gov ↗ ← All trials in China