NCT03463187

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Moderate-to-severe Chronic Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	SHR-1314	Administered subcutaneously
DRUG	Placebo	Administered subcutaneously

Timeline

• Start date: 2017-12-15
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2018-03-13
• Last updated: 2023-08-08

Locations

13 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study