What is the mechanism of action of this treatment?

The most common treatments for Chronic Rhinosinusitis (CRS) include anti-inflammatory and immunomodulatory agents such as corticosteroids and biologics. These treatments work by reducing inflammation and modulating the immune response, which helps to decrease the size and extent of nasal polyps, alleviate symptoms, and improve sinus drainage. For CRS patients, managing inflammation is crucial as it directly addresses the underlying cause of their symptoms, leading to better disease control and improved quality of life. Verekitug (UPB-101), an investigational drug, is being studied for its potential to provide similar benefits by targeting inflammatory pathways.

What side effects are associated with this type of intervention?

Common treatments for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) include biologics such as omalizumab and dupilumab. Known side effects of these treatments include nasopharyngitis, injection site reactions, and headaches. Specifically, dupilumab has been associated with a higher incidence of nasopharyngitis and injection site reactions compared to placebo. Omalizumab's effects on disease-specific health-related quality of life and severe adverse events remain uncertain due to limited data. Overall, while these treatments can be effective in reducing nasal polyp burden, they come with potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Rhinosinusitis, particularly those with nasal polyps. These treatments often include corticosteroids, such as fluticasone and mometasone, which are used to reduce inflammation. Additionally, biologic agents like dupilumab, an IL-4 receptor alpha antagonist, have been approved for their immunomodulatory effects in reducing nasal polyp size and improving symptoms. These treatments share a similar anti-inflammatory and immunomodulatory approach to Verekitug (UPB-101), which is currently being studied for its efficacy and safety in treating Chronic Rhinosinusitis with Nasal Polyps.

What other types of research exist?

Promising novel alternatives to Verekitug (UPB-101) for Chronic Rhinosinusitis patients include biologics such as Dupilumab, which targets the IL-4 receptor and has shown efficacy in reducing nasal polyp size and improving symptoms in CRSwNP. Another potential alternative is Omalizumab, an anti-IgE antibody, which has been used in allergic asthma and has shown promise in treating nasal polyps. Additionally, Mepolizumab and Benralizumab, which target IL-5, are being explored for their efficacy in CRSwNP. These agents represent the forefront of immunomodulatory treatments for CRS.

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Verekitug for Nasal Polyps (VIBRANT Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Upstream Bio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

A medical contraindication/intolerance to systemic corticosteroid.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to week 28

Summary

This trial tests a new injectable medication, verekitug (UPB-101), for people with chronic rhinosinusitis and nasal polyps who are already using nasal sprays. The goal is to see if it can shrink the polyps and improve symptoms.

Who is the study for?

This trial is for adults aged 18-75 with chronic rhinosinusitis and nasal polyps who need surgery, have ongoing symptoms like runny nose or loss of smell, and have had a past flare-up treated with steroids. They must not be able to use systemic corticosteroids, agree to the study's consent form, and have been on stable treatment for at least 30 days.

What is being tested?

The trial tests Verekitug (UPB-101) against a placebo to see if it can reduce the size of nasal polyps in patients with chronic sinus issues. Participants will receive either the actual drug or a placebo without knowing which one they are getting.

What are the potential side effects?

While specific side effects of Verekitug (UPB-101) aren't listed here, common ones may include irritation at the application site, headache, nosebleeds, or an allergic reaction. Safety and tolerability compared to a placebo are key parts of this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My nasal problem is severe enough to need surgery, confirmed by two tests.

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I cannot take systemic corticosteroids due to a medical reason or intolerance.

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I have been using a nasal spray similar to mometasone for at least 21 days.

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I am between 18 and 75 years old.

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I've needed steroids for nasal polyps in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change From Baseline in Mean Difficulty With Sense of Smell (DSS) Evaluated by the NPSD at Week 24

Change From Baseline in NPSD - Total Symptom Score (TSS) at Week 24

Change From Baseline in Opacification of Sinuses Measured by Lund Mackay Score (LMK) at Week 24

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Verekitug (UPB-101)Experimental Treatment1 Intervention

Participants will be administered 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams [mg] of verekitug [UPB-101]) subcutaneously, every 12 weeks for 24 weeks.

Group II: Matching placeboPlacebo Group1 Intervention

Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Rhinosinusitis (CRS) include anti-inflammatory and immunomodulatory agents such as corticosteroids and biologics. These treatments work by reducing inflammation and modulating the immune response, which helps to decrease the size and extent of nasal polyps, alleviate symptoms, and improve sinus drainage. For CRS patients, managing inflammation is crucial as it directly addresses the underlying cause of their symptoms, leading to better disease control and improved quality of life. Verekitug (UPB-101), an investigational drug, is being studied for its potential to provide similar benefits by targeting inflammatory pathways.