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

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

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

Study Overview

• Status: Suspended
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Biological: IL-17A Antagonist; Biological: Placebos

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200122
      • Shanghai Hengrui Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group A; SHR-1314 low dose short intervals of subcutaneous injection	Biological: IL-17A Antagonist; SHR-1314 subcutaneous injection; Other Names: SHR-1314
Active Comparator: Treatment group B; SHR-1314 high dose long intervals of subcutaneous injection	Biological: IL-17A Antagonist; SHR-1314 subcutaneous injection; Other Names: SHR-1314; Biological: Placebos; placebo subcutaneous injection to maintain consistency and to prevent blindness
Active Comparator: Treatment group C; SHR-1314 high dose short intervals of subcutaneous injection	Biological: IL-17A Antagonist; SHR-1314 subcutaneous injection; Other Names: SHR-1314; Biological: Placebos; placebo subcutaneous injection to maintain consistency and to prevent blindness
Placebo Comparator: Placebo group; Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection	Biological: IL-17A Antagonist; SHR-1314 subcutaneous injection; Other Names: SHR-1314; Biological: Placebos; placebo subcutaneous injection to maintain consistency and to prevent blindness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects reach to PASI 75 response at 16 weeks	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	16 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects achieving PASI 90 response at week 16	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.	16 week

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: SHR-1314-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No