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Nasal polyp patients may finally ditch pricey biologics

NCT ID NCT07268313

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at whether people with severe nasal polyps who have been symptom-free for at least a year on biologic drugs like Dupixent or Nucala can safely stop taking them. 66 participants will either stop their medication or continue as usual, and researchers will track if they stay well. The goal is to see if long-term control is possible without ongoing treatment.

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 66 people

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

Started

Apr 2025

Expected to finish

Jun 2027

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: 5.1 Inclusion criteria (all must be fulfilled) Inclusion criteria: At the time when the patient started biological treatment, they must have fulfilled the EPOS criteria for initiation of biologic treatment (REF EPOS): * Fulfil the criteria for CRSwNP * Presence of bilateral polyps in a patient * Had ESS (sinus surgery) (exceptional circumstances excluded) * Fulfil at least three of the following five criteria Evidence of type 2 inflammation Need for (and treated with) systemic corticosteroids or contraindication to these SNOT-22 score of 40 or above Significant loss of smell Asthma needing regular inhaled corticosteroids To enter this study, the patient must be: * Above 18 years of age * Currently be in treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) with treatment every fourth week. This treatment should have been stable/unchanged for at least three months. * Within the latest year, the patient must at all times have scored all the below symptoms of CRS five or below on a VAS scale from 0 - 10 - Doing this, it is according to the EPOS defined as controlled disease. The items are: nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell, sleep disturbance or fatigue) Please view appendix 2. * Within the latest year the nasal endoscopy cannot have showed polyp score of more than 1+1 out of 4+4, further, no thick secretions or general oedema must have been present. * Within the latest year the patient is not allowed to have had ESS or rescue treatment for their CRSwNP (antibiotics or systemic steroids) * The patient must be able to understand Danish and able to sign an informed content. Exclusion Criteria: * In the twelve months of remission the patient is not allowed to have had AECRS (acute exacerbation of chronic rhinosinusitis). A common cold is allowed. * Polyp removal in the out-patient clinic may not have been performed within the last 3 months. * In the twelve months of remission the patient cannot at any time have scored higher than 1.2 on the ACQ questionnaire, meaning that the patient does not have uncontrolled asthma (Appendix 3). * Patients who, because of language barriers, are not able to understand written information and, thus, are not able to answer questionnaires. * Patients who currently receive biologics for any other disease (asthma not included) * Patients who are not able to give informed consent (i.e., patients who are permanently incapable) * Patients who are not eligible because of the investigator's judgement * Patients who experience pregnancy during the study will be excluded after an unscheduled visit (LOCF) - active IVF treatment. (Please look belove) * Patients who have or recently have had illness, such as cancer that or its treatment is expected to significantly affect morbidity and/or quality of life in the next two years * Unwillingness to follow the study procedure * Hypersensitivity to any of either Dupilumab or Mepolizumab.

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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

    6 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

  • Dept. of otorhinolaryngology, Odense

    RECRUITING

    Odense, Region Syd, 5000, Denmark

  • Gødstrup Hospital

    RECRUITING

    Gødstrup, Denmark

  • Køge øre næse hals afd

    RECRUITING

    Køge, Region Sj, 4600, Denmark

  • Nordsjællands hospital

    RECRUITING

    Hillerød, Region H, 3400, Denmark

  • Rigshospitalet

    RECRUITING

    Copenhagen, Region H, 2100, Denmark

  • Vejle sygehus

    RECRUITING

    Vejle, Region S, 7100, Denmark

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