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

Hengrui Medicine

Status and phase: Suspended; Phase 2

Conditions: Plaque Psoriasis

Treatments: Biological: Placebos; Biological: IL-17A Antagonist

Study type: Interventional

Funder types: Industry

Identifiers

NCT04121143

SHR-1314-202

Details and patient eligibility

About

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 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Treatment group A

Active Comparator group

Description:

SHR-1314 low dose short intervals of subcutaneous injection

Treatment:

Biological: IL-17A Antagonist

Treatment group B

Active Comparator group

Description:

SHR-1314 high dose long intervals of subcutaneous injection

Treatment:

Biological: Placebos

Biological: IL-17A Antagonist

Treatment group C

Active Comparator group

Description:

SHR-1314 high dose short intervals of subcutaneous injection

Treatment:

Biological: Placebos

Biological: IL-17A Antagonist

Placebo group

Placebo Comparator group

Description:

Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection

Treatment:

Biological: Placebos

Biological: IL-17A Antagonist