Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121143
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Biological: IL-17A Antagonist Biological: Placebos Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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 Name: 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 Name: 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 Name: 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 Name: SHR-1314

Biological: Placebos
placebo subcutaneous injection to maintain consistency and to prevent blindness




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121143


Contacts
Layout table for location contacts
Contact: Qian Xu, Ph.D +86051881220000 xuqian@hrglobe.cn
Contact: Jianwen Chen, Ph.D

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04121143     History of Changes
Other Study ID Numbers: SHR-1314-202
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases