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
Full Title of Study: “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
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: March 30, 2021
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.
- Biological: IL-17A Antagonist
- SHR-1314 subcutaneous injection
- Biological: Placebos
- placebo subcutaneous injection to maintain consistency and to prevent blindness
Arms, Groups and Cohorts
- Active Comparator: Treatment group A
- SHR-1314 low dose short intervals of subcutaneous injection
- Active Comparator: Treatment group B
- SHR-1314 high dose long intervals of subcutaneous injection
- Active Comparator: Treatment group C
- SHR-1314 high dose short intervals of subcutaneous injection
- Placebo Comparator: Placebo group
- Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection
Clinical Trial Outcome Measures
- 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
- 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.
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Qian Xu, Ph.D, +86051881220000, firstname.lastname@example.org
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