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Can an antibody injection shrink nasal polyps?

NCT ID NCT06164704

Disease control Sponsor: Upstream Bio Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing an experimental antibody drug called verekitug in adults with chronic rhinosinusitis with nasal polyps, a condition where inflamed tissue grows inside the nasal passages and causes congestion. Participants receive either verekitug or a placebo injection while continuing their usual nasal steroid spray. The trial measures whether the drug reduces the size of nasal polyps and improves nasal congestion over 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental antibody drug called verekitug, given as an injection
What this could lead to
If it works, verekitug could offer a new injectable option for shrinking nasal polyps and easing congestion in people whose symptoms persist despite nasal steroid sprays.
What could go wrong
This is a phase 2 trial with about 81 participants, so it is too early to know if the benefits seen in a small group will hold up in larger studies. Injections can cause reactions, and the drug may not outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

81 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has signed, dated and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF). * Participant is aged 18 to 85 years of age (inclusive) at the time of signing the ICF. * Participant has physician diagnosed CRSwNP for at least 6 months prior to Visit 1 that fulfills all of the following: * 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. * Average NCS greater than and equal to (\>=) 2 over 14 days before Visit 2. * Ongoing symptoms of CRSwNP for at least 8 weeks prior to Visit 1 such as rhinorrhea and/or reduction in smell. * Participant has at least one of the following: * In the 24 months prior to Visit 1, had a documented exacerbation of nasal polyposis requiring treatment with systemic corticosteroid. * A medical contraindication/intolerance to systemic corticosteroid. * Had prior surgery for NP (cannot be within 6 months prior to Visit 1 * Stable standard of care treatment for CRSwNP for at least 30 days prior to Visit 1. * At Visit 2, at least 21 days of background mometasone furoate nasal spray (MFNS) (or equivalent) background therapy. * \>=70 percent (%) dosing compliance for MFNS (or equivalent) in the 14 days prior to Visit 2. * Agrees to follow the required contraceptive techniques/methods * Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last Exclusion Criteria: * Has undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to Visit 1. * Expected need, in the opinion of the Investigator, for NP surgery within 12 weeks of Visit 2. * Comorbid asthma having forced expiratory volume in 1 second (FEV1) 50% or less of predicted normal at Visit 1. * Conditions making participants non-evaluable at Visit 1 for the primary endpoint such as sino-nasal or sinus surgery changing the lateral wall structure of the nose, antrochoanal polyps, nasal septal deviation occluding at least one nostril, acute sinusitis, upper respiratory infection, ongoing rhinitis medicamentosa, fungal rhinosinusitis, nasal cavity benign or malignant tumors. * Concurrent participation in a clinical study or has been treated with an investigational drug within 28 days or 5 half-lives, whichever is longer, prior to Visit 1. * Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients. * Biologic therapy or systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 6 months or 5 half-lives before Visit 1, whichever is longer, with the exception of oral c corticosteroids. * Any vaccination within the Screening Period and treatment with a live (attenuated) vaccine within 12 weeks before Visit 2. * Abnormal medical history, physical finding or safety finding and any clinical laboratory test result outside of the reference ranges that in the opinion of the Investigator may obscure the study data or interfere with the participant's safety. Participants with any clinically significant cardiac disease and/or ECG abnormality, in the opinion of the Investigator, obtained during the Screening Period should be excluded from the study. * Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliar syndromes, concomitant cystic fibrosis. * Participant with comorbid asthma that also has a history or evidence of a clinically significant pulmonary condition (other than asthma). * History of chronic alcohol or substance use disorder within 12 months prior to Visit 1.

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Conditions

The condition(s) this trial relates to.

nasal cavity polyp nasal disorder otorhinolaryngologic disease paranasal sinus disorder respiratory system disorder sinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis with nasal polyps

Contacts and locations

Locations

  • Advanced ENT and Allergy

    Louisville, Kentucky, 40220, United States

  • Alamo Ent Associates

    San Antonio, Texas, 78258, United States

  • Alfa Medical Research

    Hollywood, Florida, 33024, United States

  • Alina Clinical Trials, LLC.

    Dallas, Texas, 75209, United States

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma, 73120-9389, United States

  • Allergy, Asthma and Sinus Center, S.C.

    Greenfield, Wisconsin, 53228, United States

  • Bellingham Asthma, Allergy & Immunology Clinic

    Bellingham, Washington, 98225, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CENTRUM SŁUCHU I MOWY Sp. z o.o.

    Nadarzyn, 05-830, Poland

  • Centro Médico Teknon

    Barcelona, 08022, Spain

  • Centrum Medyczne "All-Med" Badania Kliniczne spolka komandytowa

    Krakow, 30-033, Poland

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611, Poland

  • Centrum Medyczne Lucyna Andrzej Dymek s.c

    Strzelce Opolskie, 47-100, Poland

  • Centrum Medyczne PROMED

    Krakow, 31-513, Poland

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Chesapeake Clinical Research, Inc.

    White Marsh, Maryland, 21162, United States

  • DaVinci, Research LLC

    Roseville, California, 95661, United States

  • Ears Nose and Throat Associates of Texas

    McKinney, Texas, 75070, United States

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507-1904, United States

  • Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Consultas Externas Isaac Peral

    Madrid, 28015, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario de Jerez de la Frontera

    Cadiz, 11407, Spain

  • IMIC Inc.

    Miami, Florida, 33176, United States

  • NZZ MUDr Pavel Navratil

    Olomouc, Czech Republic, 77900, Czechia

  • Newport Native MD, Inc.

    Newport Beach, California, 92782, United States

  • Northwell Health/Division of Allergy and Immunology

    Great Neck, New York, 11021, United States

  • Novaceut Clinical Research

    Miami, Florida, 33013, United States

  • Orion Clinical Research

    Austin, Texas, 78759, United States

  • Sensa Health LA (Sensa Health Clinical Research)

    Los Angeles, California, 90006, United States

  • Senta Clinic

    San Diego, California, 92108, United States

  • Spartanburg /Greer ENT & Allergy

    Spartanburg, South Carolina, 29303, United States

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Universitaetsklinik Muenster, Klinik fur Hals-, Nasen- und Ohrenheilkunde

    Münster, 48149, Germany

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45106, United States

  • University of Missouri

    Columbus, Colorado, 65212, United States

  • University of South Florida

    Tampa, Florida, 33613-3923, United States

  • Universitätsklinik Tuebingen

    Tübingen, 72076, Germany

  • Well Pharma Medical Research Corp.

    Miami, Florida, 33173, United States

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033, United States

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