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

Last updated: February 6, 2025
Sponsor: Upstream Bio Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Soft Tissue Infections

Sinus Infections

Polyps

Treatment

Verekitug (UPB-101)

UPB-101

Placebo

Clinical Study ID

NCT06164704
UPB-CP-03
2023-508231-31-00
  • Ages 18-85
  • All Genders

Study 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.

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

Total Participants: 81
Treatment Group(s): 3
Primary Treatment: Verekitug (UPB-101)
Phase: 2
Study Start date:
December 18, 2023
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • NZZ MUDr Pavel Navratil

    Olomouc, Czech Republic 77900
    Czechia

    Site Not Available

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

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

    Muenster, 48149
    Germany

    Site Not Available

  • Universitätsklinik Tuebingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Centrum Medyczne "All-Med" Badania Kliniczne spolka komandytowa

    Kraków, 30-033
    Poland

    Site Not Available

  • Centrum Medyczne PROMED

    Kraków, 31-513
    Poland

    Site Not Available

  • CENTRUM SŁUCHU I MOWY Sp. z o.o.

    Nadarzyn, 05-830
    Poland

    Site Not Available

  • Centrum Medyczne Lucyna Andrzej Dymek s.c

    Strzelce Opolskie, 47-100
    Poland

    Site Not Available

  • Centro Médico Teknon

    Barcelona, 08022
    Spain

    Site Not Available

  • Hospital Universitario de Jerez de la Frontera

    Cadiz, 11407
    Spain

    Site Not Available

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

    Madrid, 28015
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Sensa Health LA (Sensa Health Clinical Research)

    Los Angeles, California 90006
    United States

    Site Not Available

  • NewportNativeMD, Inc.

    Newport Beach, California 92782
    United States

    Site Not Available

  • DaVinci, Research LLC

    Roseville, California 95661
    United States

    Site Not Available

  • Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.

    Roseville, California 95661
    United States

    Active - Recruiting

  • Senta Clinic

    San Diego, California 92108
    United States

    Site Not Available

  • University of Missouri

    Columbus, Colorado 65212
    United States

    Site Not Available

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • ENT & Allergy Associates of Florida

    Boynton Beach, Florida 33472
    United States

    Active - Recruiting

  • ENT & Allergy Associates of Florida / Light ENT West

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Alfa Medical Research

    Hollywood, Florida 33024
    United States

    Site Not Available

  • IMIC Inc.

    Miami, Florida 33176
    United States

    Site Not Available

  • Novaceut Clinical Research

    Miami, Florida 33013
    United States

    Site Not Available

  • Well Pharma Medical Research Corp.

    Miami, Florida 33173
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33613-3923
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Advanced ENT & Allergy

    Louisville, Kentucky 40220
    United States

    Active - Recruiting

  • Advanced ENT and Allergy

    Louisville, Kentucky 40220
    United States

    Site Not Available

  • Tandem Clinical Research GI, LLC

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Chesapeake Clinical Research, Inc.

    White Marsh, Maryland 21162
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Northwell Health/Division of Allergy and Immunology

    Great Neck, New York 11021
    United States

    Site Not Available

  • UC Health Otolaryngology - Head and Neck Surgery

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45106
    United States

    Site Not Available

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma 73120-9389
    United States

    Site Not Available

  • Spartanburg /Greer ENT & Allergy

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Orion Clinical Research

    Austin, Texas 78759
    United States

    Site Not Available

  • Alina Clinical Trials, LLC.

    Dallas, Texas 75209
    United States

    Site Not Available

  • ENT Associates of TX

    McKinney, Texas 75070
    United States

    Active - Recruiting

  • Ears Nose and Throat Associates of Texas

    McKinney, Texas 75070
    United States

    Site Not Available

  • Alamo Ent Associates

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23507-1904
    United States

    Site Not Available

  • Bellingham Asthma, Allergy & Immunology Clinic

    Bellingham, Washington 98225
    United States

    Site Not Available

  • Allergy, Asthma and Sinus Center, S.C.

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

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