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

Overview

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 to severe plaque psoriasis in adults

Full Title of Study: “Multicenter, Placebo-controlled, Parallel-randomized, Double-blind, Phase II Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of SHR-1314 Injection With Moderate to Severe Plaque Psoriasis in Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2021

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

Interventions

  • Biological: IL-17A Antagonist
    • SHR-1314 subcutaneous injection
  • Biological: Placebos
    • placebo subcutaneous injection to maintain consistency and to prevent blindness

Arms, Groups and Cohorts

  • Active Comparator: Treatment group A
    • SHR-1314 low dose short intervals of subcutaneous injection
  • Active Comparator: Treatment group B
    • SHR-1314 high dose long intervals of subcutaneous injection
  • Active Comparator: Treatment group C
    • SHR-1314 high dose short intervals of subcutaneous injection
  • Placebo Comparator: Placebo group
    • Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of subjects reach to PASI 75 response at 16 weeks
    • Time Frame: 16 week
    • Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 16

Secondary Measures

  • Proportion of subjects achieving PASI 90 response at week 16
    • Time Frame: 16 week
    • Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 90% (to achieve a PASI 90 response) relative to the baseline PASI score at Week 16 will be evaluated.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Qian Xu, Ph.D, +86051881220000, xuqian@hrglobe.cn

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