A Phase 2 interventional study of Verekitug (UPB-101) and Placebo in Chronic Rhinosinusitis With Nasal Polyps, sponsored by Upstream Bio Inc.. Completed at 41 sites in 5 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Upstream Bio Inc. · Phase 2, Interventional, and Treatment
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.
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.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's enrollment of 81 is above the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Upstream Bio Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant has physician diagnosed CRSwNP for at least 6 months prior to Visit 1 that fulfills all of the following:
Participant has at least one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Verekitug (UPB-101)
Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks.
Drug: Placebo
Verekitug (UPB-101) 0.5 mL of formulated solution (100 mg verekitug \[UPB-101\])
Verekitug (UPB-101) matching placebo
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.
Time frame: Baseline, Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 24
| Milestone | Verekitug (UPB-101) | Placebo |
|---|---|---|
| Started | 41 | 40 |
| Received at least 1 dose of study treatment | 40 | 40 |
| Completed | 40 | 35 |
| Not completed | 1 | 5 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Investigator decision | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Other than specified | 1 | 1 |
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.
| score on a scale | Verekitug | Placebo |
|---|---|---|
| Change From Baseline in Nasal Polyp Score (NPS) at Week 24 | -2.05 ± 0.26 | -0.28 ± 0.27 |
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.
| score on a scale | Verekitug | Placebo |
|---|---|---|
| Change From Baseline in the Nasal Congestion Score (NCS) Evaluated by the Nasal Polyposis Symptom Diary (NPSD) at Week 24 | -1.53 ± 0.142 | -0.76 ± 0.144 |
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.
| score on a scale | Verekitug | Placebo |
|---|---|---|
| Change From Baseline in Opacification of Sinuses Measured by Lund Mackay Score (LMK) at Week 24 | -9.45 ± 0.753 | -1.38 ± 0.784 |
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.
| score on a scale | Verekitug | Placebo |
|---|---|---|
| Change From Baseline in Mean Difficulty With Sense of Smell (DSS) Score Evaluated by the NPSD at Week 24 | -1.47 ± 0.154 | -0.62 ± 0.157 |
Reported here is the number of participants requiring systemic corticosteroids or NP surgery.
| Participants | Verekitug | Placebo |
|---|---|---|
| Participants Requiring Systemic Corticosteroids | 3 | 9 |
| Participants Requiring NP Surgery | 0 | 1 |
Reported here is the time to first NP surgery and/or use of systemic corticosteroids.
| weeks | Verekitug | Placebo |
|---|---|---|
| Time to First NP Surgery and/or Use of Systemic Corticosteroids for NP up to Week 24 | 10.00 (3.7143 to 23.1429) | 10.14 (4.8571 to 13.2857) |
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.
| score on a scale | Verekitug | Placebo |
|---|---|---|
| Change From Baseline in NPSD - Total Symptom Score (TSS) at Week 24 | -10.18 ± 0.968 | -5.49 ± 0.978 |
Collected over Up to Week 28. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Verekitug (UPB-101) | 0/40 (0%) | 0/40 (0%) | 6/40 (15%) |
| Placebo | 0/40 (0%) | 0/40 (0%) | 17/40 (42.5%) |
| Event | Verekitug (UPB-101) | Placebo |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 3/40 | 6/40 |
| Nasal polypsRespiratory, thoracic and mediastinal disorders | 0/40 | 5/40 |
| NasopharyngitisInfections and infestations | 2/40 | 3/40 |
| SinusitisInfections and infestations | 2/40 | 3/40 |
| Chronic sinusitisInfections and infestations | 0/40 | 3/40 |
The intent-to-treat (ITT) analysis set included all randomized participants.
| Age, Continuous(years) | Verekitug | Placebo | Total |
|---|---|---|---|
| Mean | 49.8 ± 13.26 | 49.6 ± 13.42 | 49.7 ± 13.25 |
| Sex: Female, Male(Participants) | Verekitug | Placebo | Total |
|---|---|---|---|
| Female | 15 | 14 | 29 |
| Male | 26 | 26 | 52 |
| Ethnicity (NIH/OMB)(Participants) | Verekitug | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 5 | 16 |
| Not Hispanic or Latino | 30 | 34 | 64 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Verekitug | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 38 | 37 | 75 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Nasal Polyp Score (NPS)(score on a scale) | Verekitug | Placebo | Total |
|---|---|---|---|
| Mean | 5.9 ± 1.62 | 6.1 ± 1.30 | 6.0 ± 1.47 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2023 to primary completion in Jul 2025, 18 months.
Results were first posted in Sep 2026, 1 year 2 months after primary completion.
Of 24 phase 2 interventional studies under Nasal Polyps, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 32. This study's 18 months is below that.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Verekitug
Upstream Bio Inc.