Phase
Condition
Soft Tissue Infections
Sinus Infections
Polyps
Treatment
Verekitug (UPB-101)
UPB-101
Placebo
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theICF.
Participant has physician diagnosed CRSwNP for at least 6 months prior to Visit 1that fulfills all of the following:
Severity consistent with need for surgery as defined by an endoscopic bilateralNPS of at least 5 out of 8 and a minimum score of 2 in each nasal cavity atVisit 1 based on central reading, as well as reconfirmed at Visit 2 based onlocal 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 asrhinorrhea 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 nasalpolyposis 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) (orequivalent) background therapy.
>=70 percent (%) dosing compliance for MFNS (or equivalent) in the 14 days prior toVisit 2.
Agrees to follow the required contraceptive techniques/methods
Female or male participant agrees not to donate eggs or sperm, respectively, for aperiod of 120 days after the last dose of the study drug intervention or at theFinal Visit, whichever occurs last
Exclusion
Exclusion Criteria:
Has undergone any intranasal and/or sinus surgery (including polypectomy) within 6months prior to Visit 1.
Expected need, in the opinion of the Investigator, for NP surgery within 12 weeks ofVisit 2.
Comorbid asthma having forced expiratory volume in 1 second (FEV1) 50% or less ofpredicted normal at Visit 1.
Conditions making participants non-evaluable at Visit 1 for the primary endpointsuch as sino-nasal or sinus surgery changing the lateral wall structure of the nose,antrochoanal polyps, nasal septal deviation occluding at least one nostril, acutesinusitis, upper respiratory infection, ongoing rhinitis medicamentosa, fungalrhinosinusitis, nasal cavity benign or malignant tumors.
Concurrent participation in a clinical study or has been treated with aninvestigational drug within 28 days or 5 half-lives, whichever is longer, prior toVisit 1.
Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of itsexcipients.
Biologic therapy or systemic immunosuppressant to treat inflammatory disease orautoimmune disease within 6 months or 5 half-lives before Visit 1, whichever islonger, 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 clinicallaboratory test result outside of the reference ranges that in the opinion of theInvestigator 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 beexcluded from the study.
Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis withpolyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome orother dyskinetic ciliar syndromes, concomitant cystic fibrosis.
Participant with comorbid asthma that also has a history or evidence of a clinicallysignificant pulmonary condition (other than asthma).
History of chronic alcohol or substance use disorder within 12 months prior to Visit
Study Design
Study Description
Connect with a study center
NZZ MUDr Pavel Navratil
Olomouc, Czech Republic 77900
CzechiaSite Not Available
Charite Universitaetsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Universitaetsklinik Muenster, Klinik fur Hals-, Nasen- und Ohrenheilkunde
Muenster, 48149
GermanySite Not Available
Universitätsklinik Tuebingen
Tuebingen, 72076
GermanySite Not Available
Centrum Medyczne Angelius Provita
Katowice, 40-611
PolandSite Not Available
Centrum Medyczne "All-Med" Badania Kliniczne spolka komandytowa
Kraków, 30-033
PolandSite Not Available
Centrum Medyczne PROMED
Kraków, 31-513
PolandSite Not Available
CENTRUM SŁUCHU I MOWY Sp. z o.o.
Nadarzyn, 05-830
PolandSite Not Available
Centrum Medyczne Lucyna Andrzej Dymek s.c
Strzelce Opolskie, 47-100
PolandSite Not Available
Centro Médico Teknon
Barcelona, 08022
SpainSite Not Available
Hospital Universitario de Jerez de la Frontera
Cadiz, 11407
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Consultas Externas Isaac Peral
Madrid, 28015
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario Virgen Macarena
Sevilla, 41009
SpainSite Not Available
Sensa Health LA (Sensa Health Clinical Research)
Los Angeles, California 90006
United StatesSite Not Available
NewportNativeMD, Inc.
Newport Beach, California 92782
United StatesSite Not Available
DaVinci, Research LLC
Roseville, California 95661
United StatesSite Not Available
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
Roseville, California 95661
United StatesActive - Recruiting
Senta Clinic
San Diego, California 92108
United StatesSite Not Available
University of Missouri
Columbus, Colorado 65212
United StatesSite Not Available
Western States Clinical Research, Inc.
Wheat Ridge, Colorado 80033
United StatesSite Not Available
ENT & Allergy Associates of Florida
Boynton Beach, Florida 33472
United StatesActive - Recruiting
ENT & Allergy Associates of Florida / Light ENT West
Boynton Beach, Florida 33472
United StatesSite Not Available
Alfa Medical Research
Hollywood, Florida 33024
United StatesSite Not Available
IMIC Inc.
Miami, Florida 33176
United StatesSite Not Available
Novaceut Clinical Research
Miami, Florida 33013
United StatesSite Not Available
Well Pharma Medical Research Corp.
Miami, Florida 33173
United StatesSite Not Available
University of South Florida
Tampa, Florida 33613-3923
United StatesSite Not Available
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesSite Not Available
The University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Advanced ENT & Allergy
Louisville, Kentucky 40220
United StatesActive - Recruiting
Advanced ENT and Allergy
Louisville, Kentucky 40220
United StatesSite Not Available
Tandem Clinical Research GI, LLC
Marrero, Louisiana 70072
United StatesSite Not Available
Chesapeake Clinical Research, Inc.
White Marsh, Maryland 21162
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Northwell Health/Division of Allergy and Immunology
Great Neck, New York 11021
United StatesSite Not Available
UC Health Otolaryngology - Head and Neck Surgery
Cincinnati, Ohio 45219
United StatesActive - Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio 45106
United StatesSite Not Available
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma 73120-9389
United StatesSite Not Available
Spartanburg /Greer ENT & Allergy
Spartanburg, South Carolina 29303
United StatesSite Not Available
Orion Clinical Research
Austin, Texas 78759
United StatesSite Not Available
Alina Clinical Trials, LLC.
Dallas, Texas 75209
United StatesSite Not Available
ENT Associates of TX
McKinney, Texas 75070
United StatesActive - Recruiting
Ears Nose and Throat Associates of Texas
McKinney, Texas 75070
United StatesSite Not Available
Alamo Ent Associates
San Antonio, Texas 78258
United StatesSite Not Available
Eastern Virginia Medical School
Norfolk, Virginia 23507-1904
United StatesSite Not Available
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington 98225
United StatesSite Not Available
Allergy, Asthma and Sinus Center, S.C.
Greenfield, Wisconsin 53228
United StatesSite Not Available
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