Clinical Trial: A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps on a

Brief Summary: The primary purpose of this study is to assess the effect of verekitug (UPB-101) on the endoscopically determined size and extend of nasal polyps in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and to assess the safety and tolerability of verekitug (UPB-101) compared to placebo.

Detailed Summary: This is a multicenter, randomized, placebo controlled, parallel group study to assess the efficacy and safety of verekitug (UPB-101) administered subcutaneously (SC) in participants with CRSwNP on background therapy with stable dosage of intranasal corticosteroids (INCS).
Approximately 70 participants will be randomized.
Participants will receive verekitug (UPB-101) or placebo over a 24-week treatment period.
In addition, this study consists of a 3 to 5-week Screening Period and a 4-week Follow-up Period.
Sponsor: Upstream Bio Inc.

Current Primary Outcome: Bilateral endoscopic NPS is a physician-reported scoring system to estimate the extent or severity of nasal polyps (NPs) based on assessments by nasal endoscopy.
Each nostril is scored on a categorical scale of 0 to 4. The total score is the sum of the right and left scores (0-8).
A higher score means severe disease.

Original Primary Outcome: Bilateral endoscopic NPS is a physician-reported scoring system to estimate the extent or severity of nasal polyps (NPs) based on assessments by nasal endoscopy.
Each nostril is scored on a categorical scale of 0 to 4. The total score is the sum of the right and left scores (0-8).
A higher score means severe disease.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Upstream Bio Inc.

Dates:
Date Received: December 01, 2023
Date Started: December 18, 2023
Date Completion: December 18, 2023
Last Updated: December 20, 2023
Last Verified: December 01, 2023