Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis

Moderate-to-severe Chronic Plaque Psoriasis Clinical Trial

Official title:
A Multi-Center, Randomized, Double-blind, Placebo-controlled, Multi-Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of SHR-1314 With Expanded Dose Finding in Subjects With Moderate-to-severe Plaque Psoriasis

Status Completed

Clinical Trial Summary

This is a multi-regional, randomized, double-blind, placebo-controlled, clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SHR-1314 in adults with moderate-to-severe plaque psoriasis.

Clinical Trial Description

This study is a multiple dose escalating design to evaluate the safety, PK, and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-1314. There are two parts in this study. The safety, PK, and PD will be evaluated in Part A, the dose escalation part. The efficacy and safety on different doses will be assessed in parallel-groups in Part B. ;

Study Design

Related Conditions & MeSH terms

Moderate-to-severe Chronic Plaque Psoriasis
Psoriasis

Clinical Trial Details

NCT number	NCT03463187
Study type	Interventional
Source	Jiangsu HengRui Medicine Co., Ltd.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 15, 2017
Completion date	August 31, 2020

View Details

See also
	Status	Clinical Trial	Phase
	Active, not recruiting	`NCT03997786` - A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis	Phase 2/Phase 3
	Completed	`NCT01076192` - Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)	N/A