Chronic SinusitisPhase 4CRSwNPNCT06824649
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
A Phase 4 study testing Biologic Agents in people with Chronic Sinusitis and Nasal Polyps, run by Medical University of South Carolina at 3 sites in United States.
Trial summary
The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis, Nasal Polyps
- What is being tested?
- Biologic Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jun 2026to Feb 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria
- Bilateral nasal polyposis visible on sinonasal endoscopy
- Nasal polyp score > 5
- Baseline SNOT-22 total score > 30
- Patient elects biologic therapy for the management of CRSwNP
- Capable of receiving all 3 biologic therapy medications.
- Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit.
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Endoscopic sinus surgery within 6-months preceding enrollment / randomization.
- Oral corticosteroid use within 30-days preceding enrollment / randomization.
- Serum IgE level outside the dosing range for omalizumab (i.e., <30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)
- Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.
- Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization.
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- Any previous treatment with any of the 3 biologic medications.
- Comorbid cystic fibrosis, CVID, or ciliary dyskinesia.
- Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Study Coordinator, 843-792-9496, sinus-research@musc.edu
- Recruiting
UF Health ENT and Allergy - The Oaks
Gainesville, Florida, 32065
Study Coordinator, 352-265-9465, fzhu9482@ufl.edu
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Research Associate, 503-494-5886, ENTResearch@ohsu.edu
About this study
Official title: SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis
The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.
- Conditions
- Chronic Sinusitis, Nasal Polyps
- Being tested
- Biologic Agents
- Keywords
- Sinusitis, Biologics
- Medical subject headings
- Nasal Polyps, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic AgentsBiological
Evidence by way of phase III clinical trials has shown efficacy of dupilumab, omalizumab, and mepolizumab to placebo, leading to regulatory approval and widespread clinical use. However, data from these clinical trials does not show universal improvement and ideal control of disease across all patients with Chronic Sinusitis with Nasal Polyps (CRSwNP). Successful completion of this trial will help answer some of the most pressing clinical questions related to biologics and CRSwNP. Specifically, findings will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Active comparator | Not described Receives: Biological: Biologic Agents |
| Omalizumab | Active comparator | Not described Receives: Biological: Biologic Agents |
| Mepolizumab | Active comparator | Not described Receives: Biological: Biologic Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Specific Quality of Life
The 22-item SinoNasal Outcome Test (SNOT-22; ©2006, Washington University, St. Louis, MO) will serve as the primary outcome of interest for all study aims/objectives. The SNOT-22 survey is a CRS-specific QOL instrument containing 22 questions (total summarized score range: 0-110) with high internal consistency and high test-retest reliability. The SNOT-22 utilizes Likert scales numbering from 0 ("No problem") to 5 "Problem as bad as it can be"). The SNOT-22 has been shown to discriminate between subjects with CRS and healthy controls, as well as identify significant differences after both medical and surgical treatments.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start3 Jun 2026
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Zachary Soler, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824649
- Sponsor's protocol ID
- Pro00141846
- Acronym
- CRSwNP
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT06824649
- Acronym / sponsor ID
- CRSwNP / Pro00141846
- Conditions
- Chronic Sinusitis, Nasal Polyps
- Keywords
- Sinusitis, Biologics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Active comparator | Biological: Biologic Agents |
| Omalizumab | Active comparator | Biological: Biologic Agents |
| Mepolizumab | Active comparator | Biological: Biologic Agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria
- Bilateral nasal polyposis visible on sinonasal endoscopy
- Nasal polyp score > 5
- Baseline SNOT-22 total score > 30
Key exclusion criteria (10 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Endoscopic sinus surgery within 6-months preceding enrollment / randomization.
- Oral corticosteroid use within 30-days preceding enrollment / randomization.
- Serum IgE level outside the dosing range for omalizumab (i.e., <30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)
- Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologic AgentsEvidence by way of phase III clinical trials has shown efficacy of dupilumab, omalizumab, and mepolizumab to placebo, leading to regulatory approval and widespread clinical use. However, data from these clinical trials does not show universal improvement and ideal control of disease across all patients with Chronic Sinusitis with Nasal Polyps (CRSwNP). Successful completion of this trial will help answer some of the most pressing clinical questions related to biologics and CRSwNP. Specifically, findings will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy. | Biological | Dupilumab, Mepolizumab, Omalizumab |
Primary outcome
Disease-Specific Quality of Life
Time frame: 24 weeks
The 22-item SinoNasal Outcome Test (SNOT-22; ©2006, Washington University, St. Louis, MO) will serve as the primary outcome of interest for all study aims/objectives. The SNOT-22 survey is a CRS-specific QOL instrument containing 22 questions (total summarized score range: 0-110) with high internal consistency and high test-retest reliability. The SNOT-22 utilizes Likert scales numbering from 0 ("No problem") to 5 "Problem as bad as it can be"). The SNOT-22 has been shown to discriminate between subjects with CRS and healthy controls, as well as identify significant differences after both medical and surgical treatments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zachary Soler, MD principal investigator
Medical University of South Carolina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biologic Agents in people with Chronic Sinusitis and Nasal Polyps, run by Medical University of South Carolina at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Associate ((503) 494-5886, ENTResearch@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Specific Quality of Life (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.