#1 Clinical Trials Search in Europe

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

2 1

What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
ORL ambulance MUDr. Pavel Navratil Olomouc Czechia
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Centrum Medyczne Lucyna Andrzej Dymek s.c. – Strzelce Opolskie Strzelce Opolskie Poland
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Cueqlsi Sevxjp i Mivc Mpmuzjte Nadarzyn Poland
Uqnlzhotdleoqiidbxlfj Mpdcukrx Ajm Munster Germany
Pgamewv Sbk z oqtu Katowice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
15.07.2024
Germany Germany
Not recruiting
15.07.2024
Poland Poland
Not recruiting
15.07.2024
Spain Spain
Not recruiting
15.07.2024

Trial locations

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.

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 ID:
2023-508231-31-00
Protocol code:
UPB-CP-03
NCT ID:
NCT06164704
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on How Mepolizumab Affects Patients with Chronic Rhinosinusitis with Nasal Polyps

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Reducing Biologic Treatments Mepolizumab and Dupilumab for Patients with Severe Chronic Rhinosinusitis with Nasal Polyps

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark