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Verekitug (UPB-101) for Chronic Rhinosinusitis (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

Awards & highlights

VIBRANT Trial Summary

This trial aims to evaluate the impact of verekitug (UPB-101) on the size and extent of nasal polyps in individuals diagnosed with chronic rhinosinusitis with nasal polyps (

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.Check my eligibility

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.See study design

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.

VIBRANT Trial 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.

VIBRANT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

VIBRANT 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

Find a Location

Who is running the clinical trial?

Upstream Bio Inc.Lead Sponsor

3 Previous Clinical Trials

500 Total Patients Enrolled

Kiran Patel, MDStudy DirectorUpstream Bio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently open for enrollment?

"Indeed, the information available on clinicaltrials.gov confirms that this particular clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on December 18th, 2023 and it was most recently edited on December 20th, 2023. The study aims to enroll a total of 70 participants across two designated locations."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, according to the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted on December 18, 2023 and recently updated on December 20, 2023. Recruitment aims to enroll a total of 70 individuals across two designated sites."

Answered by AI

Is the age criterion for participation in this research limited to individuals below 70 years old?

"To be considered eligible for this clinical trial, applicants must fall within the age range of 18 to 75. It is worth noting that there are a total of 7 studies specifically designed for individuals under the age of 18, and an additional 98 studies targeted towards those over the age of 65."

Answered by AI

Is it possible for me to participate in this medical study?

"Participants must also experience ongoing symptoms of CRSwNP such as rhinorrhea and"

Answered by AI

What is the level of safety associated with Verekitug (UPB-101) in relation to patient usage?

"Based on our team's evaluation at Power, the safety rating for Verekitug (UPB-101) is 2. This rating reflects that while there is some available data supporting its safety in this Phase 2 trial, there is currently no evidence supporting its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06164704.

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