Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516302
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Clinical Trial Evaluating the Efficacy Safety and Immunogenicity of GR1802 in Participants With Chronic Rhinosinusitis With Nasal Polyps
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps CRSwNP in adults It will also learn about the safety of GR1802 The main questions it aims to answer are
1 Does GR1802 reduce the need for surgery and systemic corticosteroid use
2 What medical problems do participants have when taking GR1802
Researchers will compare GR1802 to a placebo a look-alike substance that contains no drug to see if GR1802 works to treat CRSwNP
Participants will
Take GR1802 or a placebo once every 2 weeks for 13months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray
1 Does GR1802 reduce the need for surgery and systemic corticosteroid use
2 What medical problems do participants have when taking GR1802
Researchers will compare GR1802 to a placebo a look-alike substance that contains no drug to see if GR1802 works to treat CRSwNP
Participants will
Take GR1802 or a placebo once every 2 weeks for 13months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray
Detailed Description:
A randomized double-blind placebo-controlled multi-center clinical trial was designed The clinical trial was divided into 4 stages screeningintroduction period double-blind treatment period maintenance treatment period and safety follow-up period
The clinical trial aimed to evaluate the efficacy safety and immunogenicity of GR1802 injection in CRSwNP participants
The clinical trial aimed to evaluate the efficacy safety and immunogenicity of GR1802 injection in CRSwNP participants
Study Oversight
Has Oversight DMC:
None
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?:
None