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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04121143
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jiangsu HengRui Medicine Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Qian Xu, Ph.D

[email protected]e.cn

+86051881220000

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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