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

September 17, 2026 updated by: Upstream Bio Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Upstream Bio Clinical Trials Information (Privacy Notice: https://www.upstreambio.com/privacy)
  • Phone Number: 888-446-3130
  • Email: clinicaltrials@upstreambio.com

Study Locations

  • Czechia
    • Czech Republic
      • Olomouc, Czech Republic, Czechia, 77900
        • NZZ MUDr Pavel Navratil
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin
      • Münster, Germany, 48149
        • Universitaetsklinik Muenster, Klinik fur Hals-, Nasen- und Ohrenheilkunde
      • Tübingen, Germany, 72076
        • Universitätsklinik Tuebingen
  • Poland
      • Katowice, Poland, 40-611
        • Centrum Medyczne Angelius Provita
      • Krakow, Poland, 31-513
        • Centrum Medyczne PROMED
      • Krakow, Poland, 30-033
        • Centrum Medyczne "All-Med" Badania Kliniczne spolka komandytowa
      • Nadarzyn, Poland, 05-830
        • CENTRUM SŁUCHU I MOWY Sp. z o.o.
      • Strzelce Opolskie, Poland, 47-100
        • Centrum Medyczne Lucyna Andrzej Dymek s.c
  • Spain
      • Barcelona, Spain, 08022
        • Centro Medico Teknon
      • Cadiz, Spain, 11407
        • Hospital Universitario de Jerez de la Frontera
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28015
        • Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Consultas Externas Isaac Peral
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
  • United States
    • California
      • Los Angeles, California, United States, 90006
        • Sensa Health LA (Sensa Health Clinical Research)
      • Newport Beach, California, United States, 92782
        • Newport Native MD, Inc.
      • Roseville, California, United States, 95661
        • DaVinci, Research LLC
      • San Diego, California, United States, 92108
        • Senta Clinic
    • Colorado
      • Columbus, Colorado, United States, 65212
        • University of Missouri
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research, Inc.
    • Florida
      • Hollywood, Florida, United States, 33024
        • Alfa Medical Research
      • Miami, Florida, United States, 33173
        • Well Pharma Medical Research Corp.
      • Miami, Florida, United States, 33013
        • Novaceut Clinical Research
      • Miami, Florida, United States, 33176
        • IMIC Inc.
      • Tampa, Florida, United States, 33613-3923
        • University of South Florida
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Kentucky
      • Louisville, Kentucky, United States, 40220
        • Advanced ENT and Allergy
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • Chesapeake Clinical Research, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health/Division of Allergy and Immunology
    • Ohio
      • Cincinnati, Ohio, United States, 45106
        • University of Cincinnati Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120-9389
        • Allergy, Asthma & Clinical Research Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg /Greer ENT & Allergy
    • Texas
      • Austin, Texas, United States, 78759
        • Orion Clinical Research
      • Dallas, Texas, United States, 75209
        • Alina Clinical Trials, LLC.
      • McKinney, Texas, United States, 75070
        • Ears Nose and Throat Associates of Texas
      • San Antonio, Texas, United States, 78258
        • Alamo Ent Associates
    • Virginia
      • Norfolk, Virginia, United States, 23507-1904
        • Eastern Virginia Medical School
    • Washington
      • Bellingham, Washington, United States, 98225
        • Bellingham Asthma, Allergy & Immunology Clinic
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Allergy, Asthma and Sinus Center, S.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant has signed, dated and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
  • Participant is aged 18 to 85 years of age (inclusive) at the time of signing the ICF.

  • Participant has physician diagnosed CRSwNP for at least 6 months prior to Visit 1 that fulfills all of the following:

    • Severity consistent with need for surgery as defined by an endoscopic bilateral NPS of at least 5 out of 8 and a minimum score of 2 in each nasal cavity at Visit 1 based on central reading, as well as reconfirmed at Visit 2 based on local reading.
    • Average NCS greater than and equal to (>=) 2 over 14 days before Visit 2.
    • Ongoing symptoms of CRSwNP for at least 8 weeks prior to Visit 1 such as rhinorrhea and/or reduction in smell.

  • Participant has at least one of the following:

    • In the 24 months prior to Visit 1, had a documented exacerbation of nasal polyposis requiring treatment with systemic corticosteroid.
    • A medical contraindication/intolerance to systemic corticosteroid.
    • Had prior surgery for NP (cannot be within 6 months prior to Visit 1
  • Stable standard of care treatment for CRSwNP for at least 30 days prior to Visit 1.
  • At Visit 2, at least 21 days of background mometasone furoate nasal spray (MFNS) (or equivalent) background therapy.
  • >=70 percent (%) dosing compliance for MFNS (or equivalent) in the 14 days prior to Visit 2.
  • Agrees to follow the required contraceptive techniques/methods
  • Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last

Exclusion Criteria:

  • Has undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to Visit 1.
  • Expected need, in the opinion of the Investigator, for NP surgery within 12 weeks of Visit 2.
  • Comorbid asthma having forced expiratory volume in 1 second (FEV1) 50% or less of predicted normal at Visit 1.
  • Conditions making participants non-evaluable at Visit 1 for the primary endpoint such as sino-nasal or sinus surgery changing the lateral wall structure of the nose, antrochoanal polyps, nasal septal deviation occluding at least one nostril, acute sinusitis, upper respiratory infection, ongoing rhinitis medicamentosa, fungal rhinosinusitis, nasal cavity benign or malignant tumors.
  • Concurrent participation in a clinical study or has been treated with an investigational drug within 28 days or 5 half-lives, whichever is longer, prior to Visit 1.
  • Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients.
  • Biologic therapy or systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 6 months or 5 half-lives before Visit 1, whichever is longer, with the exception of oral c corticosteroids.
  • Any vaccination within the Screening Period and treatment with a live (attenuated) vaccine within 12 weeks before Visit 2.
  • Abnormal medical history, physical finding or safety finding and any clinical laboratory test result outside of the reference ranges that in the opinion of the Investigator may obscure the study data or interfere with the participant's safety. Participants with any clinically significant cardiac disease and/or ECG abnormality, in the opinion of the Investigator, obtained during the Screening Period should be excluded from the study.
  • Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliar syndromes, concomitant cystic fibrosis.
  • Participant with comorbid asthma that also has a history or evidence of a clinically significant pulmonary condition (other than asthma).
  • History of chronic alcohol or substance use disorder within 12 months prior to Visit 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Verekitug (UPB-101)
Participants will be administered 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams [mg] of verekitug [UPB-101]) subcutaneously, every 12 weeks for 24 weeks.
Drug: Verekitug (UPB-101)
Verekitug (UPB-101) 0.5 mL of formulated solution (100 mg verekitug [UPB-101])
Placebo Comparator: Matching placebo
Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks.
Drug: Placebo
Verekitug (UPB-101) matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Nasal Polyp Score (NPS) at Week 24
Time Frame: Baseline, Week 24
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 with a lower score indicating smaller-sized nasal polyps. The total score is the sum of the right and left scores (0-8). A higher score means more severe disease.
Baseline, Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Nasal Congestion Score (NCS) Evaluated by the Nasal Polyposis Symptom Diary (NPSD) at Week 24
Time Frame: Baseline, Week 24
Nasal congestion was reported by participants daily, recalling nasal congestion severity over the previous 24 hours as none, mild, moderate, or severe (scores of 0, 1, 2, or 3, respectively). The NCS was calculated as the 14-day average of the daily scores. Scores ranged from 0 to 3 with higher scores representing more severe congestion.
Baseline, Week 24
Change From Baseline in Opacification of Sinuses Measured by Lund Mackay Score (LMK) at Week 24
Time Frame: Baseline, Week 24
LMK score or sinus opacification score is a physician-reported quality staging system for evaluation of severity of NPs based on assessments of the sinuses by computer tomography (CT). The LMK staging system assigns a value of 0, 1, or 2 to each of the following 5 sinuses: maxillary, anterior ethmoid, posterior ethmoid, frontal, and sphenoid where in 0=sinus is totally patent, 1=sinus is partially opacified, 2=sinus completely opacified. The osteomeatal complex is also scored. Total score ranges from 0 to 24 with a higher score representing more severe disease.
Baseline, Week 24
Change From Baseline in Mean Difficulty With Sense of Smell (DSS) Score Evaluated by the NPSD at Week 24
Time Frame: Baseline, Week 24
DSS, recalled over the past 24 hours, was reported. For the assessment, participants assessed their DSS for the previous day on a 4-point verbal scale of 0=none to 3=severe and record it in the electronic Diary. Scores ranged from 0 to 3 with higher scores representing greater severity.
Baseline, Week 24
Number of Participants Requiring Systemic Corticosteroids or NP Surgery
Time Frame: Up to Week 24
Reported here is the number of participants requiring systemic corticosteroids or NP surgery.
Up to Week 24
Time to First NP Surgery and/or Use of Systemic Corticosteroids for NP up to Week 24
Time Frame: Up to Week 24
Reported here is the time to first NP surgery and/or use of systemic corticosteroids.
Up to Week 24
Change From Baseline in NPSD - Total Symptom Score (TSS) at Week 24
Time Frame: Baseline, Week 24
Participants completed a NPSD each morning, reporting common symptoms of nasal polyposis and symptom impacts. Participants reported severity of 8 symptoms and symptom impact at its worst using a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The TSS was calculated by taking the sum of the 8 equally weighted symptom items over a period of 2 weeks and ranged from 0-24 with a higher TSS score indicating a greater severity.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Upstream Bio Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kiran Patel, MD, Upstream Bio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPB-CP-03
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-508231-31-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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