Rhinosinusitis
Do you suffer from chronic
with nasal polyps? You may be eligible to participate in a clinical research study.
Study Overview
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.
Inclusion Criteria:
Participant is aged 18 to 75 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
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.
Agrees to follow the required contraceptive techniques/methods
Exclusion Criteria:
Has undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to Visit 1.
Comorbid asthma having forced expiratory volume in 1 second (FEV1) 50% or less of predicted normal at Visit 1.
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.
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.
Participant with comorbid asthma that also has a history or evidence of a clinically significant pulmonary condition (other than asthma).
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.