A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis
NCT ID: NCT06875934
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
145 participants
INTERVENTIONAL
2025-03-28
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SHR-1139 injection group
SHR-1139 Injection
SHR-1139 injection.
SHR-1139 injection placebo group
SHR-1139 Injection Placebo
SHR-1139 injection placebo.
Interventions
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SHR-1139 Injection
SHR-1139 injection.
SHR-1139 Injection Placebo
SHR-1139 injection placebo.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Guangdong Hengrui Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SHR-1139-201
Identifier Type: -
Identifier Source: org_study_id
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