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Clinical trial

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

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Last updated:30th Oct 2019
Identifier: NCT04121143

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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date: October 30, 2019
Estimated Primary Completion Date: March 30, 2021
Estimated Study Completion Date: June 15, 2021

Arms:
- Active Comparator:
Treatment group A
- Active Comparator: Treatment group B
- Active Comparator: Treatment group C
- Placebo Comparator: Placebo group

Category Value
Date last updated at source 2019-10-09
Study type(s) Interventional
Expected enrolment 120
Study start date 2019-10-30
Estimated primary completion date 2019-03-30

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