Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783389
Status:
TERMINATED
Last Update Posted:
2023-10-17
First Post:
2021-02-24
Brief Title:
A Study to Evaluate CBP-201 Rademikibart in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps
Sponsor:
Suzhou Connect Biopharmaceuticals Ltd
Organization:
Suzhou Connect Biopharmaceuticals Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial was discontinued in 2022 due to COVID-19 pandemic and UkraineRussia conflict related enrollment challenges Discontinuation was not related to safety
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effect of CBP-201 rademikibart in adult patients with Chronic Rhinosinusitis with Nasal Polyps CRSwNP
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled study to evaluate the effect of CBP-201 on a background of mometasone furoate nasal spray MFNS in reducing endoscopic nasal polyp score NPS and nasal congestionobstruction score NCS severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid INCS therapy in comparison to placebo CBP-201 is administered as a subcutaneous SC injection The study is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None