A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps
NCT ID: NCT06164704
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2023-12-18
2025-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Verekitug (UPB-101)
Verekitug (UPB-101) 0.5 mL of formulated solution (100 mg verekitug \[UPB-101\])
Matching placebo
Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks.
Placebo
Verekitug (UPB-101) matching placebo
Interventions
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Verekitug (UPB-101)
Verekitug (UPB-101) 0.5 mL of formulated solution (100 mg verekitug \[UPB-101\])
Placebo
Verekitug (UPB-101) matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Upstream Bio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kiran Patel, MD
Role: STUDY_DIRECTOR
Upstream Bio
Locations
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Sensa Health LA (Sensa Health Clinical Research)
Los Angeles, California, United States
NewportNativeMD, 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
Countries
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Other Identifiers
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2023-508231-31-00
Identifier Type: CTIS
Identifier Source: secondary_id
UPB-CP-03
Identifier Type: -
Identifier Source: org_study_id
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