A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Oct 8, 2019

Keywords

ClinConnect Summary

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-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.

Gender

ALL

Eligibility criteria

• * Inclusion Criteria:
• • 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 Criteria:
• • 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.