NCT06875934Active, not recruitingPhase 2
A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Patients With Moderate-to-severe Plaque Psoriasis
Source: ClinicalTrials.gov · Last updated 14 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 145 (actual)
- First submitted
- 9 Mar 2025
- Start date
- 28 Mar 2025
- Primary completion date
- Nov 2025
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- Psoriasis
- NCT number
- NCT06875934
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 145
- From 28 Mar 2025 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- There are other skin problems that researchers believe can interfere with the evaluation of psoriasis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Dermatology Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.