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

NCT06164704 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: UPB-CP-032023-508231-31-00
• Study Type: interventional
• Target: 81
• Locations: 5 countries
• Sites: 41

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

CRSwNP; Nasal Corticosteroids; VIBRANT; Nasal Polyps; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Nasal Polyp Score (NPS) at Week 24

  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.

  At Week 24

Secondary Outcomes (7)

• Change From Baseline in the Nasal Congestion Score (NCS) Evaluated by the Nasal Polyposis Symptom Diary (NPSD) at Week 24

  At Week 24

• Change From Baseline in Opacification of Sinuses Measured by Lund Mackay Score (LMK) at Week 24

  At Week 24

• Change From Baseline in Mean Difficulty With Sense of Smell (DSS) Evaluated by the NPSD at Week 24

  At Week 24

• Percentage 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

  Up to Week 24

Study Arms (2)

Verekitug (UPB-101)

EXPERIMENTAL

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)

Matching placebo

PLACEBO COMPARATOR

Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks.

Drug: Placebo

Interventions

Verekitug (UPB-101) DRUG

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

Verekitug (UPB-101)

Placebo DRUG

Verekitug (UPB-101) matching placebo

Matching placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Upstream Bio Inc.: lead

Study Sites (41)

Sensa Health LA (Sensa Health Clinical Research)

Los Angeles, California, 90006, United States

Location

NewportNativeMD, Inc.

Newport Beach, California, 92782, United States

Location

DaVinci, Research LLC

Roseville, California, 95661, United States

Location

Senta Clinic

San Diego, California, 92108, United States

Location

University of Missouri

Columbus, Colorado, 65212, United States

Location

Western States Clinical Research, Inc.

Wheat Ridge, Colorado, 80033, United States

Location

Alfa Medical Research

Hollywood, Florida, 33024, United States

Location

Novaceut Clinical Research

Miami, Florida, 33013, United States

Location

Well Pharma Medical Research Corp.

Miami, Florida, 33173, United States

Location

IMIC Inc.

Miami, Florida, 33176, United States

Location

University of South Florida

Tampa, Florida, 33613-3923, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40220, United States

Location

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21162, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Northwell Health/Division of Allergy and Immunology

Great Neck, New York, 11021, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45106, United States

Location

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120-9389, United States

Location

Spartanburg /Greer ENT & Allergy

Spartanburg, South Carolina, 29303, United States

Location

Orion Clinical Research

Austin, Texas, 78759, United States

Location

Alina Clinical Trials, LLC.

Dallas, Texas, 75209, United States

Location

Ears Nose and Throat Associates of Texas

McKinney, Texas, 75070, United States

Location

Alamo Ent Associates

San Antonio, Texas, 78258, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507-1904, United States

Location

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, Washington, 98225, United States

Location

Allergy, Asthma and Sinus Center, S.C.

Greenfield, Wisconsin, 53228, United States

Location

NZZ MUDr Pavel Navratil

Olomouc, Czech Republic, 77900, Czechia

Location

Charite Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

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

Münster, 48149, Germany

Location

Universitätsklinik Tuebingen

Tübingen, 72076, Germany

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Centrum Medyczne "All-Med" Badania Kliniczne spolka komandytowa

Krakow, 30-033, Poland

Location

Centrum Medyczne PROMED

Krakow, 31-513, Poland

Location

CENTRUM SŁUCHU I MOWY Sp. z o.o.

Nadarzyn, 05-830, Poland

Location

Centrum Medyczne Lucyna Andrzej Dymek s.c

Strzelce Opolskie, 47-100, Poland

Location

Centro Médico Teknon

Barcelona, 08022, Spain

Location

Hospital Universitario de Jerez de la Frontera

Cadiz, 11407, Spain

Location

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

Madrid, 28015, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Nasal Polyps; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections

Study Officials

• Kiran Patel, MD

  Upstream Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 18, 2023
• Primary Completion: July 7, 2025
• Study Completion: July 22, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); DE (3); CZ (1); US (27); PL (5)