Chronic Rhinosinusitis With Nasal PolypsPhase 2VIBRANTNCT06164704
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps
A Phase 2 study testing Verekitug (UPB-101) in people with Chronic Rhinosinusitis With Nasal Polyps, run by Upstream Bio Inc. at 41 sites in 5 countries.
Trial summary
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 participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and to assess the safety and tolerability of verekitug (UPB-101) compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Verekitug (UPB-101)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 41 sitesin 5 countries
- Study dates
- 18 Dec 2023to 22 Jul 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
41 sites in 5 countries.
41 sites in 5 countries
United States27 sites
Orion Clinical Research
Austin, Texas, 78759
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, 98225
Treasure Valley Medical Research
Boise, Idaho, 83706
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The University of Chicago
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45106
University of Missouri
Columbus, Colorado, 65212
Alina Clinical Trials, LLC.
Dallas, Texas, 75209
Northwell Health/Division of Allergy and Immunology
Great Neck, New York, 11021
Allergy, Asthma and Sinus Center, S.C.
Greenfield, Wisconsin, 53228
Alfa Medical Research
Hollywood, Florida, 33024
Sensa Health LA (Sensa Health Clinical Research)
Los Angeles, California, 90006
Advanced ENT and Allergy
Louisville, Kentucky, 40220
Ears Nose and Throat Associates of Texas
McKinney, Texas, 75070
Novaceut Clinical Research
Miami, Florida, 33013
Well Pharma Medical Research Corp.
Miami, Florida, 33173
IMIC Inc.
Miami, Florida, 33176
Newport Native MD, Inc.
Newport Beach, California, 92782
Eastern Virginia Medical School
Norfolk, Virginia, 23507-1904
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120-9389
DaVinci, Research LLC
Roseville, California, 95661
Alamo Ent Associates
San Antonio, Texas, 78258
Senta Clinic
San Diego, California, 92108
Spartanburg /Greer ENT & Allergy
Spartanburg, South Carolina, 29303
University of South Florida
Tampa, Florida, 33613-3923
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
Poland5 sites
Centrum Medyczne Angelius Provita
Katowice, 40-611
Centrum Medyczne "All-Med" Badania Kliniczne spolka komandytowa
Krakow, 30-033
Centrum Medyczne PROMED
Krakow, 31-513
CENTRUM SŁUCHU I MOWY Sp. z o.o.
Nadarzyn, 05-830
Centrum Medyczne Lucyna Andrzej Dymek s.c
Strzelce Opolskie, 47-100
Spain5 sites
Centro Médico Teknon
Barcelona, 08022
Hospital Universitario de Jerez de la Frontera
Cadiz, 11407
Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Consultas Externas Isaac Peral
Madrid, 28015
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Virgen Macarena
Seville, 41009
Germany3 sites
Charite Universitaetsmedizin Berlin
Berlin, 10117
Universitaetsklinik Muenster, Klinik fur Hals-, Nasen- und Ohrenheilkunde
Münster, 48149
Universitätsklinik Tuebingen
Tübingen, 72076
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps on a Background of Nasal Corticosteroids (VIBRANT)
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 participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and to assess the safety and tolerability of verekitug (UPB-101) compared to placebo.
Read the detailed description
This is a multicenter, randomized, placebo controlled, parallel group study to assess the efficacy and safety of verekitug (UPB-101) administered subcutaneously (SC) in participants with CRSwNP on background therapy with stable dosage of intranasal corticosteroids (INCS). Approximately 70 participants will be randomized. Participants will receive verekitug (UPB-101) or placebo over a 24-week treatment period. In addition, this study consists of a 3 to 5-week Screening Period and a 4-week Follow-up Period.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Verekitug (UPB-101), Placebo
- Keywords
- CRSwNP, Nasal Corticosteroids, VIBRANT, Nasal Polyps, Sinusitis, Paranasal Sinus Diseases, Nose Diseases, Respiratory Tract Diseases, Otorhinolaryngologic Diseases
- Medical subject headings
- Nasal Polyps, Sinusitis, Paranasal Sinus Diseases, Nose Diseases, Respiratory Tract Diseases, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verekitug (UPB-101)Drug
Verekitug (UPB-101) 0.5 mL of formulated solution (100 mg verekitug [UPB-101])
PlaceboDrug
Verekitug (UPB-101) matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Verekitug (UPB-101) | Experimental | 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. Receives: Drug: Verekitug (UPB-101) |
| Matching placebo | Placebo comparator | Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Nasal Polyp Score (NPS) at Week 24
NPS is a physician-reported scoring system to estimate the extent or severity of nasal polyps (NPs) based on assessments by nasal endoscopy. Each nostril is scored on a categorical scale of 0 to 4 with a lower score indicating smaller-sized nasal polyps. The total score is the sum of the right and left scores (0-8). A higher score means more severe disease.
Measured: Baseline, Week 24
Secondary outcomes (6)
Change From Baseline in the Nasal Congestion Score (NCS) Evaluated by the Nasal Polyposis Symptom Diary (NPSD) at Week 24
Nasal congestion was reported by participants daily, recalling nasal congestion severity over the previous 24 hours as none, mild, moderate, or severe (scores of 0, 1, 2, or 3, respectively). The NCS was calculated as the 14-day average of the daily scores. Scores ranged from 0 to 3 with higher scores representing more severe congestion.
Measured: Baseline, Week 24
Change From Baseline in Opacification of Sinuses Measured by Lund Mackay Score (LMK) at Week 24
LMK score or sinus opacification score is a physician-reported quality staging system for evaluation of severity of NPs based on assessments of the sinuses by computer tomography (CT). The LMK staging system assigns a value of 0, 1, or 2 to each of the following 5 sinuses: maxillary, anterior ethmoid, posterior ethmoid, frontal, and sphenoid where in 0=sinus is totally patent, 1=sinus is partially opacified, 2=sinus completely opacified. The osteomeatal complex is also scored. Total score ranges from 0 to 24 with a higher score representing more severe disease.
Measured: Baseline, Week 24
Change From Baseline in Mean Difficulty With Sense of Smell (DSS) Score Evaluated by the NPSD at Week 24
DSS, recalled over the past 24 hours, was reported. For the assessment, participants assessed their DSS for the previous day on a 4-point verbal scale of 0=none to 3=severe and record it in the electronic Diary. Scores ranged from 0 to 3 with higher scores representing greater severity.
Measured: Baseline, Week 24
Number of Participants Requiring Systemic Corticosteroids or NP Surgery
Reported here is the number of participants requiring systemic corticosteroids or NP surgery.
Measured: Up to Week 24
Time to First NP Surgery and/or Use of Systemic Corticosteroids for NP up to Week 24
Reported here is the time to first NP surgery and/or use of systemic corticosteroids.
Measured: Up to Week 24
Change From Baseline in NPSD - Total Symptom Score (TSS) at Week 24
Participants completed a NPSD each morning, reporting common symptoms of nasal polyposis and symptom impacts. Participants reported severity of 8 symptoms and symptom impact at its worst using a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The TSS was calculated by taking the sum of the 8 equally weighted symptom items over a period of 2 weeks and ranged from 0-24 with a higher TSS score indicating a greater severity.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start18 Dec 2023
- Primary completion7 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Upstream Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164704
- Sponsor's protocol ID
- UPB-CP-03
- Other IDs
- 2023-508231-31-00, 2023
- Acronym
- VIBRANT
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2023
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.
PubMed 39393433