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

Primary Purpose

Plaque Psoriasis

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IL-17A Antagonist
Placebos
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Treatment group C

Placebo group

Arm Description

SHR-1314 low dose short intervals of subcutaneous injection

SHR-1314 high dose long intervals of subcutaneous injection

SHR-1314 high dose short intervals of subcutaneous injection

Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 27, 2019
Last Updated
March 19, 2020
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04121143
Brief Title
A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults
Official Title
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
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Suspended
Why Stopped
sponsor's decision
Study Start Date
November 9, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A
Arm Type
Active Comparator
Arm Description
SHR-1314 low dose short intervals of subcutaneous injection
Arm Title
Treatment group B
Arm Type
Active Comparator
Arm Description
SHR-1314 high dose long intervals of subcutaneous injection
Arm Title
Treatment group C
Arm Type
Active Comparator
Arm Description
SHR-1314 high dose short intervals of subcutaneous injection
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
IL-17A Antagonist
Other Intervention Name(s)
SHR-1314
Intervention Description
SHR-1314 subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Placebos
Intervention Description
placebo subcutaneous injection to maintain consistency and to prevent blindness
Primary Outcome Measure Information:
Title
Proportion of subjects reach to PASI 75 response at 16 weeks
Description
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
Time Frame
16 week
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving PASI 90 response at week 16
Description
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.
Time Frame
16 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Shanghai Hengrui Pharmaceutical Co., Ltd.
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200122
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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