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Which biologic is best for nasal polyps? new study aims to find out

NCT ID NCT06824649

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This study will compare three FDA-approved biologic drugs (dupilumab, omalizumab, and mepolizumab) in 504 adults with chronic sinusitis and nasal polyps. The goal is to see which drug works best for different patients and whether simple tests can predict who will improve the most. Participants will receive one of the biologics and be followed for changes in quality of life and symptoms.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 504 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

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