Last updated on February 2018

Safety and Efficacy Study of Etanercept (Qiangke ) to Treat Moderate to Severe Plaque Psoriasis


Brief description of study

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke) in the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the different maintaining treatment programme in Moderate to Severe plaque psoriasis by Qiangke. And the second purpose is to assess the efficacy and safety of Qiangke in Moderate to Severe Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque psoriasis patients,and at the first stage they will be randomized divided into three group: full-dose of Qiangke group, half-dose of Qiangke group and placebo group.And the blind stage will last for 12 weeks. Then at the second stage, all patients will receive 50mg qw of Qiangke for additional 12 weeks.

Detailed Study Description

Psoriasis is a chronic inflammatory skin disease that can lead to significant physical and psychologic distress for patients.Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke) can block the role of the cytokine tumor necrosis factor (TNF)-alpha.

TNF- plays a major role in the pathophysiology of both PsoriasisPsOand Psoriatic Arthritis (PsA). TNF- levels are elevated in psoriatic skin lesions, serum samples, and synovial fluid. Anti-TNF- therapy has shown efficacy in treating psoriatic skin lesions, joint pain and swelling, enthesitis, and dactylitis plus the ability to improve mobility, reduce radiographic progression of disease, and influence quality of life parameters.

Qiangke is a dimeric, soluble fusion protein consisting of the extracellular ligand binding portion of the TNF receptor linked to the Fc portion of human Immunoglobulin gamma-1IgG1. It is capable of binding and neutralizing soluble TNF and transmembrane TNF. It alters neutrophil migration and dendritic cell and T-cell maturation and migration, thus decreasing the local and systemic production of pro-inflammatory cytokines and their subsequent effects.

Clinical Study Identifier: NCT02701205

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