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
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 with a lower score indicating smaller-sized nasal polyps. The total score is the sum of the right and left scores (0-8). A higher score means more severe disease.
Time frame: Baseline, Week 24
Change From Baseline in the Nasal Congestion Score (NCS) Evaluated by the Nasal Polyposis Symptom Diary (NPSD) at Week 24
Nasal congestion was 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). The NCS was calculated as the 14-day average of the daily scores. Scores ranged from 0 to 3 with higher scores representing more severe congestion.
Time frame: Baseline, 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). 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. The osteomeatal complex is also scored. Total score ranges from 0 to 24 with a higher score representing more severe disease.
Time frame: Baseline, Week 24
Change From Baseline in Mean Difficulty With Sense of Smell (DSS) Score Evaluated by the NPSD at Week 24
DSS, recalled over the past 24 hours, was reported. For the assessment, participants assessed 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. Scores ranged from 0 to 3 with higher scores representing greater severity.
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Sensa Health LA (Sensa Health Clinical Research)
Los Angeles, California, United States
Newport Native MD, 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
Time frame: Baseline, Week 24
Number of Participants Requiring Systemic Corticosteroids or NP Surgery
Reported here is the number of participants requiring systemic corticosteroids or NP surgery.
Time frame: Up to Week 24
Time to First NP Surgery and/or Use of Systemic Corticosteroids for NP up to Week 24
Reported here is the time to first NP surgery and/or use of systemic corticosteroids.
Time frame: Up to Week 24
Change From Baseline in NPSD - Total Symptom Score (TSS) at Week 24
Participants completed a NPSD each morning, reporting common symptoms of nasal polyposis and symptom impacts. Participants reported severity of 8 symptoms and symptom impact at its worst using a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The TSS was calculated by taking the sum of the 8 equally weighted symptom items over a period of 2 weeks and ranged from 0-24 with a higher TSS score indicating a greater severity.
Time frame: Baseline, Week 24