70 Participants Needed

Verekitug for Nasal Polyps

(VIBRANT Trial)

Recruiting at 44 trial locations
UB
UB
Overseen ByUpstream Bio Clinical Trials Information (Privacy Notice: https://www.upstreambio.com/privacy)
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Upstream Bio Inc.
Must be taking: Mometasone furoate
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a new treatment, verekitug (UPB-101), for individuals with chronic rhinosinusitis and nasal polyps. The goal is to determine if verekitug can reduce nasal polyp size and improve symptoms compared to a placebo. Participants will receive either the treatment or a placebo every 12 weeks for 24 weeks. The trial seeks individuals diagnosed with nasal polyps severe enough to consider surgery and who experience ongoing symptoms like a runny nose or reduced sense of smell. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have stable treatment for nasal polyps for at least 30 days before starting the trial and continue using a nasal spray like mometasone furoate during the trial.

Is there any evidence suggesting that verekitug (UPB-101) is likely to be safe for humans?

Research has shown that verekitug (UPB-101) has been tested in people with chronic rhinosinusitis with nasal polyps. In a recent study, participants received the treatment every 12 weeks for a total of 24 weeks. They tolerated it well, and the treatment significantly reduced the size of the polyps. No major safety issues arose during this period, suggesting that verekitug is generally safe for humans, with no serious side effects noted in the study.12345

Why do researchers think this study treatment might be promising for nasal polyps?

Most treatments for nasal polyps involve corticosteroids or surgery, which aim to reduce inflammation and remove the polyps. However, verekitug (UPB-101) is unique because it introduces a new mechanism of action by targeting specific pathways involved in the growth of nasal polyps. Researchers are excited about this treatment because it is administered subcutaneously every 12 weeks, offering a potentially more convenient and less invasive alternative to existing therapies. Additionally, verekitug contains a novel active ingredient, which could provide a more targeted approach, potentially resulting in better outcomes for patients with nasal polyps.

What evidence suggests that verekitug might be an effective treatment for nasal polyps?

Research has shown that verekitug (UPB-101), which participants in this trial may receive, may help shrink nasal polyps in people with chronic rhinosinusitis with nasal polyps (CRSwNP). In a recent study, patients who received verekitug every 12 weeks experienced a noticeable reduction in the size and number of their polyps compared to those who did not take the drug. The results were statistically significant, indicating they were unlikely due to chance, and clinically meaningful, demonstrating real benefits for patients. This makes verekitug a strong option among treatments for this condition.12678

Who Is on the Research Team?

KP

Kiran Patel, MD

Principal Investigator

Upstream Bio

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My nasal problem is severe enough to need surgery, confirmed by two tests.
I cannot take systemic corticosteroids due to a medical reason or intolerance.
I had surgery for my condition more than 6 months ago.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 to 5 weeks

Treatment

Participants receive verekitug (UPB-101) or placebo subcutaneously every 12 weeks for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Verekitug (UPB-101)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Verekitug (UPB-101)Experimental Treatment1 Intervention
Group II: Matching placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Upstream Bio Inc.

Lead Sponsor

Trials
4
Recruited
570+

Citations

Release DetailsIn this 24-week study, VIBRANT met its primary endpoint, with verekitug dosed every 12 weeks leading to a statistically significant and ...
NCT06164704 | A Study to Investigate the Efficacy and ...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 ...
Verekitug heads to late-stage trials after Phase II successThis Phase II data keeps Upstream Bio's verekitug in contention with AstraZeneca and Amgen's Teszpire in terms of efficacy.
Verekitug Phase 2 CRSwNP Top-line ResultsNOTE: For illustrative purposes only. Efficacy data are derived from different clinical trials conducted at different times with differences in ...
Phase 2 VIBRANT Trial: Verekitug Improves Nasal Polyps ...The VIBRANT trial results demonstrated statistically significant and clinically meaningful benefits with verekitug dosed every 12 weeks ...
Rhinosinusitis with nasal polyps clinical study: VIBRANTThis study is evaluating the safety and efficacy of a study drug called verekitug (UPB-101) compared to placebo. Brigham and Women's Hospital Sinusitis Nose ...
A Study to Investigate the Efficacy and Safety of Verekitug ...The primary purpose of this study is to assess the effect of verekitug (UPB-101) on the endoscopically determined size and extend of nasal ...
Upstream Bio Presents Data Showing Structural and ...Data show verekitug prevents TSLP binding to the TSLP receptor by occupying ligand binding sites –. – Additionally, findings show that ...
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