Status:
ACTIVE_NOT_RECRUITING
A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Moderate to Severe Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
- 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.
- 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).
- Female subjects must have negative pregnancy test results during the screening period and before randomized administration, and must be non-lactating.
Exclusion
- There are other skin problems that researchers believe can interfere with the evaluation of psoriasis.
- 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.
- Had an opportunistic infection within 6 months prior to screening.
- Allergic to the ingredients or excipients of the study drug.
- The investigator determined that there were conditions that affected the safety and efficacy evaluation of the study drug.
Key Trial Info
Start Date :
March 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT06875934
Start Date
March 28 2025
End Date
October 1 2026
Last Update
July 14 2025
Active Locations (1)
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1
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China, 200435