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

Phase 2

Suspended

• Conditions: Plaque Psoriasis
• Interventions: Biological: IL-17A Antagonist; Biological: Placebos

• Registration Number: NCT04121143
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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 to severe plaque psoriasis in adults

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 Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Study Start: 2019-11-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	IL-17A Antagonist	SHR-1314 low dose short intervals of subcutaneous injection
Treatment group C	Placebos	SHR-1314 high dose short intervals of subcutaneous injection
Treatment group B	IL-17A Antagonist	SHR-1314 high dose long intervals of subcutaneous injection
Treatment group B	Placebos	SHR-1314 high dose long intervals of subcutaneous injection
Treatment group C	IL-17A Antagonist	SHR-1314 high dose short intervals of subcutaneous injection
Placebo group	IL-17A Antagonist	Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection
Placebo group	Placebos	Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Proportion of subjects reach to PASI 75 response at 16 weeks	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 Outcome Measures

Name	Time	Method
Proportion of subjects achieving PASI 90 response at week 16	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.

Trial Locations

Locations (1)

Shanghai Hengrui Pharmaceutical Co., Ltd.; 🇨🇳 Shanghai, Shanghai, China