Verekitug for Nasal Polyps

(VIBRANT Trial)

Recruiting at 44 trial locations

Overseen By Upstream 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

Must not be taking: Biologics, Immunosuppressants

Disqualifiers: Asthma, Sinus surgery, Cardiac disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Kiran Patel, MD

Principal Investigator

Upstream Bio

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Verekitug (UPB-101) Experimental Treatment 1 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 placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Upstream Bio Inc.

Lead Sponsor

Trials

4

Recruited

570+