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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Verekitug (UPB-101) 0.5 mL of formulated solution (100 mg verekitug \[UPB-101\])
Verekitug (UPB-101) matching placebo
Change From Baseline in Nasal Polyp Score (NPS) at Week 24
Bilateral endoscopic NPS is a physician-reported scoring system to estimate the extent or severity of nasal polyps (NPs) based on assessments by nasal endoscopy. Each nostril is scored on a categorical scale of 0 to 4. The total score is the sum of the right and left scores (0-8). A higher score means severe disease.
Time frame: At Week 24
Change From Baseline in the Nasal Congestion Score (NCS) Evaluated by the Nasal Polyposis Symptom Diary (NPSD) at Week 24
Nasal congestion will be reported by participants daily, recalling nasal congestion severity over the previous 24 hours as none, mild, moderate, or severe (scores of 0, 1, 2, or 3, respectively). A higher score means worse outcome.
Time frame: At Week 24
Change From Baseline in Opacification of Sinuses Measured by Lund Mackay Score (LMK) at Week 24
LMK score or sinus opacification score is a physician-reported quality staging system for evaluation of severity of NPs based on assessments of the sinuses by computer tomography (CT). CT scans will not be performed in Germany and Czechia. The LMK staging system assigns a value of 0, 1, or 2 to each of the following 5 sinuses: maxillary, anterior ethmoid, posterior ethmoid, frontal, and sphenoid where in 0=sinus is totally patent, 1=sinus is partially opacified, 2=sinus completely opacified; A higher score means severe disease.
Time frame: At Week 24
Change From Baseline in Mean Difficulty With Sense of Smell (DSS) Evaluated by the NPSD at Week 24
Loss of smell based on participant-reported assessment of symptom severity of DSS, recalled over the past 24 hours. For the assessment, participants will be asked to assess their DSS for the previous day on a 4-point verbal scale of 0=none to 3=severe and record it in the electronic Diary. Higher daily DSS score indicates greater severity.
Time frame: At Week 24
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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
...and 31 more locations
Percentage of Participants Requiring Systemic Corticosteroids or NP Surgery
Percentage of participants requiring systemic corticosteroids or NP surgery will be recorded.
Time frame: Up to Week 24
Time to First NP Surgery and/or Use of Systemic Corticosteroids for NP up to Week 24
Time to first NP surgery and/or use of systemic corticosteroids for NP will be recorded.
Time frame: Up to Week 24
Change From Baseline in NPSD - Total Symptom Score (TSS) at Week 24
Participants will complete a NPSD each morning. Questions will be asked to report common symptoms of nasal polyposis and symptom impacts. Participants will report severity of each symptom and symptom impact at its worse using a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). Higher score indicates more severe symptoms.
Time frame: At Week 24
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From Baseline up to Week 28