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

NCT04121143 | Suspended Phase 2 FDA Drug

• 1 other identifier: SHR-1314-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of subjects achieving PASI 90 response at week 16

  16 week

Study Arms (4)

Treatment group A

ACTIVE COMPARATOR

SHR-1314 low dose short intervals of subcutaneous injection

Biological: IL-17A Antagonist

Treatment group B

ACTIVE COMPARATOR

SHR-1314 high dose long intervals of subcutaneous injection

Biological: IL-17A Antagonist; Biological: Placebos

Treatment group C

ACTIVE COMPARATOR

SHR-1314 high dose short intervals of subcutaneous injection

Biological: IL-17A Antagonist; Biological: Placebos

Placebo group

PLACEBO COMPARATOR

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

Biological: IL-17A Antagonist; Biological: Placebos

Interventions

IL-17A Antagonist BIOLOGICAL

SHR-1314 subcutaneous injection

Also known as: SHR-1314

Placebo group; Treatment group A; Treatment group B; Treatment group C

Placebos BIOLOGICAL

placebo subcutaneous injection to maintain consistency and to prevent blindness

Placebo group; Treatment group B; Treatment group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Hengrui Pharmaceutical Co., Ltd.

Shanghai, Shanghai Municipality, 200122, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 9, 2019
• Study Start: November 9, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)