A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults
NCT ID: NCT04121143
Last Updated: 2020-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
120 participants
INTERVENTIONAL
2019-11-09
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group A
SHR-1314 low dose short intervals of subcutaneous injection
IL-17A Antagonist
SHR-1314 subcutaneous injection
Treatment group B
SHR-1314 high dose long intervals of subcutaneous injection
IL-17A Antagonist
SHR-1314 subcutaneous injection
Placebos
placebo subcutaneous injection to maintain consistency and to prevent blindness
Treatment group C
SHR-1314 high dose short intervals of subcutaneous injection
IL-17A Antagonist
SHR-1314 subcutaneous injection
Placebos
placebo subcutaneous injection to maintain consistency and to prevent blindness
Placebo group
Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection
IL-17A Antagonist
SHR-1314 subcutaneous injection
Placebos
placebo subcutaneous injection to maintain consistency and to prevent blindness
Interventions
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IL-17A Antagonist
SHR-1314 subcutaneous injection
Placebos
placebo subcutaneous injection to maintain consistency and to prevent blindness
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Hengrui Pharmaceutical Co., Ltd.
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SHR-1314-202
Identifier Type: -
Identifier Source: org_study_id
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