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.

Contact us to confirm eligibility