Clinical trial NCT04121143: 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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of subjects reach to PASI 75 response at 16 weeks
timeFrame: 16 week
Secondary outcomes:
measure: Proportion of subjects achieving PASI 90 response at week 16
timeFrame: 16 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Hengrui Pharmaceutical Co., Ltd.
state: Shanghai
Study officials:
References: