Status:
SUSPENDED
A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate ...
Detailed Description
This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-131...
Eligibility Criteria
Inclusion
- Provide written informed consent before any study assessment is performed.
- Male or female at least 18 years of age at screening.
- Chronic plaque psoriasis history ≥ 6 months;At the time of randomization, moderate to severe plaque psoriasis.
- Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
- The body mass index (BMI) was ≥18 kg/m2 and ≤35 kg/m2 at screening.
Exclusion
- Diagnosis of psoriasis at screening is not chronic plaque psoriasis
- Severe infection or systemic infection before baseline
- There are other skin problems that researchers believe will hinder the evaluation of psoriasis.
- Subject has a history or symptom of malignancy within 5 years prior to screening, regardless of whether or not treatment has been received, with or without signs of recurrence or metastasis.
- The investigators believe that the subject is not suitable for any clinical condition involved in the clinical study.
- Those who are allergic to the study ingredients or excipients, or who are allergic to other biological agents.
- There is evidence that hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) confirmation test is positive.
- Subject's medical history, symptoms and examination results suggest active tuberculosis or latent tuberculosis.
- Laboratory tests have clinical implications at screening, and the investigators believe that participation in the study may pose unacceptable risks to the subject or impede data analysis.
- Women who are pregnant or breastfeeding at screening or at baseline
- The investigator believes that it will prevent the subject from following and completing any other circumstances of the study protocol.
Key Trial Info
Start Date :
November 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04121143
Start Date
November 9 2019
End Date
December 30 2020
Last Update
March 23 2020
Active Locations (1)
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1
Shanghai Hengrui Pharmaceutical Co., Ltd.
Shanghai, Shanghai Municipality, China, 200122