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COMPLETED
NCT06164704
PHASE2

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

Sponsor: Upstream Bio Inc.

View on ClinicalTrials.gov

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.

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 Background of Nasal Corticosteroids (VIBRANT)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2023-12-18

Completion Date

2025-07-22

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DRUG

Verekitug (UPB-101)

Verekitug (UPB-101) 0.5 mL of formulated solution (100 mg verekitug \[UPB-101\])

DRUG

Placebo

Verekitug (UPB-101) matching placebo

Locations (41)

Sensa Health LA (Sensa Health Clinical Research)

Los Angeles, California, United States

Newport Native MD, Inc.

Newport Beach, California, United States

DaVinci, Research LLC

Roseville, California, United States

Senta Clinic

San Diego, California, United States

University of Missouri

Columbus, Colorado, United States

Western States Clinical Research, Inc.

Wheat Ridge, Colorado, United States

Alfa Medical Research

Hollywood, Florida, United States

Novaceut Clinical Research

Miami, Florida, United States

Well Pharma Medical Research Corp.

Miami, Florida, United States

IMIC Inc.

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Treasure Valley Medical Research

Boise, Idaho, United States

The University of Chicago

Chicago, Illinois, United States

Advanced ENT and Allergy

Louisville, Kentucky, United States

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Northwell Health/Division of Allergy and Immunology

Great Neck, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, United States

Spartanburg /Greer ENT & Allergy

Spartanburg, South Carolina, United States

Orion Clinical Research

Austin, Texas, United States

Alina Clinical Trials, LLC.

Dallas, Texas, United States

Ears Nose and Throat Associates of Texas

McKinney, Texas, United States

Alamo Ent Associates

San Antonio, Texas, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, Washington, United States

Allergy, Asthma and Sinus Center, S.C.

Greenfield, Wisconsin, United States

NZZ MUDr Pavel Navratil

Olomouc, Czech Republic, Czechia

Charite Universitaetsmedizin Berlin

Berlin, Germany

Universitaetsklinik Muenster, Klinik fur Hals-, Nasen- und Ohrenheilkunde

Münster, Germany

Universitätsklinik Tuebingen

Tübingen, Germany

Centrum Medyczne Angelius Provita

Katowice, Poland

Centrum Medyczne "All-Med" Badania Kliniczne spolka komandytowa

Krakow, Poland

Centrum Medyczne PROMED

Krakow, Poland

CENTRUM SŁUCHU I MOWY Sp. z o.o.

Nadarzyn, Poland

Centrum Medyczne Lucyna Andrzej Dymek s.c

Strzelce Opolskie, Poland

Centro Médico Teknon

Barcelona, Spain

Hospital Universitario de Jerez de la Frontera

Cadiz, Spain

Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Consultas Externas Isaac Peral

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain