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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04121143
• Other study ID #: SHR-1314-202
• Status: Suspended
• Phase: Phase 2
• Start date: November 9, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• IL-17A Antagonist
SHR-1314 subcutaneous injection
• Placebos
placebo subcutaneous injection to maintain consistency and to prevent blindness

Locations

Country	Name	City	State
China	Shanghai Hengrui Pharmaceutical Co., Ltd.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects reach to PASI 75 response at 16 weeks	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	16 week
Secondary	Proportion of subjects achieving PASI 90 response at week 16	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.	16 week