CompletedPhase 2

A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps

United States, Czechia, Germany81 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 range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Nasal Polyp Score (NPS) at Week 24

Timeframe: At Week 24

Trial details

NCT IDNCT06164704

SponsorUpstream Bio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-07

View on ClinicalTrials.gov More Chronic Rhinosinusitis With Nasal Polyps trials