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CompletedPhase 2

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

Key facts

Who runs it
Upstream Bio Inc.
Where
Austin, Bellingham, Boise, Boston, Chicago, Cincinnati, Columbus, Dallas, Great Neck, Greenfield, Hollywood, Los Angeles, Louisville, McKinney, Miami, Newport Beach, Norfolk, Oklahoma City, Roseville, San Antonio, San Diego, Spartanburg, Tampa, Wheat Ridge, and White Marsh, United StatesSee the 27 sitesAlso in 4 other countries, 15 sites
Status
Completed
Phase
Phase 2
People taking part
81 people enrolled
Started
18 Dec 2023
Ended
22 Jul 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Verekitug (UPB-101)
  • Placebo
Record updated
18 September 2026

Who can take part

Age
18 years to 85 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Any vaccination within the Screening Period and treatment with a live (attenuated) vaccine within 12 weeks before Visit 2
  • 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
  • History of chronic alcohol or substance use disorder within 12 months prior to 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
  • 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
  • Participant with comorbid asthma that also has a history or evidence of a clinically significant pulmonary condition (other than asthma)
  • 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
  • Comorbid asthma having forced expiratory volume in 1 second (FEV1) 50% or less of predicted normal at Visit 1

Where in United States

Also in 4 other countries, 15 sites

  • Orion Clinical ResearchAustin, United States
  • Bellingham Asthma, Allergy Immunology ClinicBellingham, United States
  • Treasure Valley Medical ResearchBoise, United States
  • Brigham and Women's HospitalBoston, United States
  • The University Of ChicagoChicago, United States
  • University of Cincinnati Medical CenterCincinnati, United States
  • University of MissouriColumbus, United States
  • Alina Clinical Trials, LLC.Dallas, United States
  • Northwell Health/Division of Allergy and ImmunologyGreat Neck, United States
  • Allergy, Asthma and Sinus Center, S.C.Greenfield, United States
  • Alfa Medical ResearchHollywood, United States
  • Sensa Health LA (Sensa Health Clinical Research)Los Angeles, United States
  • Advanced ENT and AllergyLouisville, United States
  • Ears Nose and Throat Associates of TexasMcKinney, United States
  • IMIC, Inc.Miami, United States
  • Novaceut Clinical ResearchMiami, United States
  • Well Pharma Medical Research Corp.Miami, United States
  • Newport Native Md, Inc.Newport Beach, United States
  • Eastern Virginia Medical SchoolNorfolk, United States
  • Allergy, Asthma & Clinical Research CenterOklahoma City, United States
  • DaVinci Research LLCRoseville, United States
  • Alamo ENT AssociatesSan Antonio, United States
  • Senta ClinicSan Diego, United States
  • Spartanburg /Greer ENT & AllergySpartanburg, United States
  • University of South FloridaTampa, United States
  • Western States Clinical Research, Inc.Wheat Ridge, United States
  • Chesapeake Clinical Research, Inc.White Marsh, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Verekitug (UPB-101)Treatment being tested

    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.

  • Matching placeboPlacebo, for comparison

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

    Treatment: Placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Record updated
18 September 2026