A Study Assessing the Efficacy and Safety of CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps
A Study Assessing the Efficacy and Safety of CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps
Brief Summary:
This study will evaluate the effect of CBP-201 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
Detailed Description:
This is a multi-center, 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 congestion/obstruction 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 Type: Interventional (Clinical Trial)
Estimated Enrollment: 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps
Estimated Study Start Date: March 2021
Estimated Primary Completion Date: July 2022
Estimated Study Completion Date: January 2023
Arm:
- Experimental: CBP-201 Dose 1
- Experimental: CBP-201 Dose 2
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 132 |
| Estimated Study start date | 01 March 2021 |
| Estimated Study Completion Date | 01 January 2023 |