NCT04783389

A Study to Evaluate CBP-201, Rademikibart, in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Connect Biopharm LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	CBP-201	CBP-201 subcutaneous (SC) injection.
DRUG	Placebo	Placebo subcutaneous (SC) injection.

Timeline

• Start date: 2021-06-16
• Primary completion: 2022-04-15
• Completion: 2022-06-10
• First posted: 2021-03-05
• Last updated: 2023-10-17
• Results posted: 2023-10-17

Locations

68 sites across 5 countries: United States, China, Poland, Spain, Ukraine

Regulatory

• FDA-regulated drug study