Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-01 @ 9:57 AM
Study NCT ID:
NCT02701205
Status:
UNKNOWN
Last Update Posted:
2016-03-08
First Post:
2016-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Etanercept (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis
Sponsor:
Shanghai Celgen Bio-Pharmaceutical Co.,Ltd
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Safety and Efficacy Study of Recombinant Human TNF Receptor-IgG Fusion Protein for Injection (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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-α plays a major role in the pathophysiology of both Psoriasis（PsO）and Psoriatic Arthritis (PsA). TNF-α levels are elevated in psoriatic skin lesions, serum samples, and synovial fluid. Anti-TNF-α 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-1（IgG1）. 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.
TNF-α plays a major role in the pathophysiology of both Psoriasis（PsO）and Psoriatic Arthritis (PsA). TNF-α levels are elevated in psoriatic skin lesions, serum samples, and synovial fluid. Anti-TNF-α 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-1（IgG1）. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: