A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chroni… (NCT06164704) | Clinical Trial Compass
CompletedPhase 2
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps
United States81 participantsStarted 2023-12-18
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Participant has signed, dated and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
* Participant is aged 18 to 85 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 that fulfills all of the following:
* Severity consistent with need for surgery as defined by an endoscopic bilateral NPS of at least 5 out of 8 and a minimum score of 2 in each nasal cavity at Visit 1 based on central reading, as well as reconfirmed at Visit 2 based on local reading.
* Average NCS greater than and equal to (\>=) 2 over 14 days before Visit 2.
* Ongoing symptoms of CRSwNP for at least 8 weeks prior to Visit 1 such as rhinorrhea and/or reduction in smell.
* 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.
* At Visit 2, at least 21 days of background mometasone furoate nasal spray (MFNS) (or equivalent) background therapy.
* \>=70 percent (%) dosing compliance for MFNS (or equivalent) in the 14 days prior to Visit 2.
* Agrees to follow…
What they're measuring
1
Change From Baseline in Nasal Polyp Score (NPS) at Week 24