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Study on the Effects of Verekitug (UPB-101) for Patients with Chronic Rhinosinusitis with Nasal Polyps Using Nasal Corticosteroids

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called Verekitug (UPB-101) for people with Chronic Rhinosinusitis with Nasal Polyps. This condition involves long-term inflammation of the sinuses, which leads to the growth of polyps in the nasal passages, causing symptoms like nasal congestion and difficulty breathing. The treatment being tested is a solution for injection that contains a special type of protein known as a human IgG1 kappa monoclonal antibody, which targets a specific protein involved in the disease process.

The purpose of the study is to evaluate how effective and safe Verekitug (UPB-101) is when used alongside standard nasal corticosteroid treatments. Participants in the study will receive either the new treatment or a placebo, which is a solution that looks like the treatment but contains no active medication. The study will last for about 24 weeks, during which participants will have regular check-ups to monitor their condition and any changes in their symptoms.

Throughout the study, participants will continue using their usual nasal spray treatment, and their progress will be closely observed by healthcare professionals. The study aims to provide valuable information on whether Verekitug (UPB-101) can help reduce the size of nasal polyps and improve symptoms for those living with this chronic condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will have already signed and received a copy of the informed consent form. This document outlines the study's requirements and restrictions.

  2. Step 2

    Initial assessment

    The participant will undergo an initial assessment to confirm the diagnosis of chronic rhinosinusitis with nasal polyps. This condition must have been diagnosed by a physician at least six months prior to the first visit.

  3. Step 3

    Background treatment

    The participant must have been on a stable treatment for chronic rhinosinusitis with nasal polyps for at least 30 days before the first visit. This includes using mometasone furoate nasal spray or an equivalent for at least 21 days before the second visit.

  4. Step 4

    Treatment phase

    The participant will receive either Verekitug (UPB-101) or a placebo. The medication is administered as a subcutaneous injection. The specific dosage and frequency will be determined by the study protocol.

  5. Step 5

    Monitoring and assessments

    Throughout the study, the participant will undergo regular assessments to monitor changes in nasal polyps and sinus opacification. These assessments will occur at various intervals, including a primary evaluation at week 24.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, the participant will have a final evaluation to assess the overall effect of the treatment on nasal polyps and any other health changes.

  7. Step 7

    Follow-up period

    After completing the treatment phase, the participant will enter a follow-up period. During this time, additional assessments may be conducted to monitor long-term effects and any adverse events.

Who can join the trial?

10 criteria

  • The participant must have signed, dated, and received a copy of the written informed consent form. This form is approved by an ethics committee and includes all the rules and requirements for the study.
  • The participant must be between 18 and 75 years old at the time of signing the consent form.
  • The participant must have been diagnosed by a doctor with **Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)** for at least 6 months before the first visit.
  • The participant must have at least one of the following:
    • In the past 24 months, had a worsening of nasal polyps that needed treatment with **systemic corticosteroids** (a type of medication that reduces inflammation).
    • A medical reason or intolerance that prevents them from using systemic corticosteroids.
    • Had surgery for nasal polyps, but not within 6 months before the first visit.
    • The participant must have been on a stable treatment plan for CRSwNP for at least 30 days before the first visit.
    • At the second visit, the participant must have been using **mometasone furoate nasal spray** (or a similar treatment) for at least 21 days.
    • The participant must have used the nasal spray as directed at least 70% of the time in the 14 days before the second visit.
    • The participant must use contraception methods that follow local regulations for those taking part in clinical studies.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than Chronic Rhinosinusitis with Nasal Polyps cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who are not part of the specified clinical trial groups are not eligible.
  • Both males and females can participate, so gender is not an exclusion factor.
  • Vulnerable populations, such as those who might not be able to give informed consent, are not included in this study.
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Investigated drugs

Verekitug (UPB-101) is a medication being studied for its potential to help people with chronic rhinosinusitis with nasal polyps. This condition involves inflammation and growth of polyps in the nasal passages, which can cause congestion and breathing difficulties. The trial is investigating how effective and safe Verekitug is when used alongside nasal corticosteroids, which are commonly prescribed to reduce inflammation in the nasal passages.

What is already known about the treatment

Verekitug (UPB-101) – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating chronic rhinosinusitis with nasal polyps. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for Verekitug is to reduce nasal polyp size and improve symptoms in affected individuals. At the molecular level, it works by targeting specific pathways involved in inflammation, helping to decrease the formation and growth of nasal polyps. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Chronic Rhinosinusitis with Nasal Polyps – This condition is characterized by the inflammation of the nasal passages and sinuses lasting for more than 12 weeks, accompanied by the growth of polyps in the nasal cavity. These polyps are non-cancerous, soft, and painless, but they can cause nasal congestion, loss of smell, and difficulty breathing. The disease often results in a feeling of pressure in the face and forehead, and it may lead to frequent sinus infections. The polyps can vary in size and may grow in clusters, potentially blocking the nasal passages. The condition is more common in adults and can be associated with asthma or allergies. It tends to be a chronic issue, requiring ongoing management to alleviate symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508231-31-00Protocol codeUPB-CP-03Estimated enrolment109 patientsSponsorUpstream Bio Inc.

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