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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Upstream Bio Inc.
Study ID
NCT06164704
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Verekitug (UPB-101) — DRUG
    Verekitug (UPB-101) 0.5 mL of formulated solution (100 mg verekitug \[UPB-101\])
  • Placebo — DRUG
    Verekitug (UPB-101) matching placebo

Study Details

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.

Key Dates

First listed
Dec 11, 2023
Start date
Dec 18, 2023
Status verified
Aug 2025
Primary completion
Jul 7, 2025
Completion
Jul 22, 2025

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: Matching placebo
    Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks.

Primary Outcome Measure

Change From Baseline in Nasal Polyp Score (NPS) at Week 24 [ Time Frame: At Week 24 ]

Locations (27)

FacilityCityStateZIPSite coordinators
Sensa Health LA (Sensa Health Clinical Research)Los AngelesCalifornia90006-
NewportNativeMD, Inc.Newport BeachCalifornia92782-
DaVinci, Research LLCRosevilleCalifornia95661-
Senta ClinicSan DiegoCalifornia92108-
University of MissouriColumbusColorado65212-
Western States Clinical Research, Inc.Wheat RidgeColorado80033-
Alfa Medical ResearchHollywoodFlorida33024-
IMIC Inc.MiamiFlorida33176-
Novaceut Clinical ResearchMiamiFlorida33013-
Well Pharma Medical Research Corp.MiamiFlorida33173-
University of South FloridaTampaFlorida33613-3923-
Treasure Valley Medical ResearchBoiseIdaho83706-
The University of ChicagoChicagoIllinois60637-
Advanced ENT and AllergyLouisvilleKentucky40220-
Chesapeake Clinical Research, Inc.White MarshMaryland21162-
Brigham and Women's HospitalBostonMassachusetts02115-
Northwell Health/Division of Allergy and ImmunologyGreat NeckNew York11021-
University of Cincinnati Medical CenterCincinnatiOhio45106-
Allergy, Asthma & Clinical Research CenterOklahoma CityOklahoma73120-9389-
Spartanburg /Greer ENT & AllergySpartanburgSouth Carolina29303-
Orion Clinical ResearchAustinTexas78759-
Alina Clinical Trials, LLC.DallasTexas75209-
Ears Nose and Throat Associates of TexasMcKinneyTexas75070-
Alamo Ent AssociatesSan AntonioTexas78258-
Eastern Virginia Medical SchoolNorfolkVirginia23507-1904-
Bellingham Asthma, Allergy & Immunology ClinicBellinghamWashington98225-
Allergy, Asthma and Sinus Center, S.C.GreenfieldWisconsin53228-

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