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Nasal polyps trial tests stretching biologic doses

NCT ID NCT07187583

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether people with chronic nasal polyps who are stable on biologic drugs like dupilumab or mepolizumab can safely extend the time between doses from every 4 weeks to every 6 or 8 weeks. The goal is to see if symptom control can be maintained with fewer injections. 135 adults who have been on a steady dose for at least three months will participate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
biologic drugs (dupilumab or mepolizumab)
What this could lead to
If successful, this could allow patients with chronic nasal polyps to take their medication less often while still controlling symptoms, reducing treatment burden and side effects.
What could go wrong
This is a Phase 4 trial with only 135 participants, so results may not apply to everyone. Some patients might lose disease control with longer dosing intervals, requiring a return to the original schedule.

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 135 people

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

Started

Jun 2025

Expected to finish

Mar 2028

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: * ≥18 years of age. * Currently receiving treatment with either dupilumab (300 mg) or mepolizumab (100 mg) every four weeks. * Having received the biologic at unchanged dosing interval for at least three months. * For at least one year during treatment with biologics, the patients' CRSwNP must be categorized as "partly controlled" as defined by presence of 1-2 of the following seven items (also available in EPOS 2020 table in protocol): 1. Nasal blockage: present on most days of the week 2. Rhinorrhoea/postnasal drip: mucopurulent on most days of the week 3. Facial pain/pressure: present on most days of the week 4. Sense of smell: impaired 5. Sleep disturbance or fatigue: present 6. Nasal endoscopy: diseased mucosa 7. Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment of which 1-5 will be scored by the patient using VAS (0-10) and noted above 5. Exclusion Criteria: * Patients with excellent response to biologics (0 of the above-mentioned 7 items for partly controlled disease) * Patients with no or limited response to biologics (\>2 of the above-mentioned 7 items for partly controlled disease) * Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial * Patients who, because of language barriers, are not able to understand Danish 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 - active IVF treatment (please see below) * Unwillingness to follow the study procedure

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As listed by the trial registrant

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

Chronic rhinosinusitis with nasal polyps

How to take part

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

  1. The places running it

    9 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

  • Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Dept of otorhinolaryngology, Aalborg University Hospital

    NOT_YET_RECRUITING

    Aalborg, 9000, Denmark

  • Dept of otorhinolaryngology, Gødstrup Regional Hospital

    NOT_YET_RECRUITING

    Herning, 7400, Denmark

  • Dept of otorhinolaryngology, Lillebaelt Hospital

    NOT_YET_RECRUITING

    Vejle, 7100, Denmark

  • Dept of otorhinolaryngology, Nordsjaellands Hospital

    RECRUITING

    Hillerød, 3400, Denmark

  • Dept of otorhinolaryngology, Odense University Hospital

    NOT_YET_RECRUITING

    Odense, 5000, Denmark

  • Dept of otorhinolaryngology, Sjællands Universitetshospital

    RECRUITING

    Køge, 4600, Denmark

  • Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital

    NOT_YET_RECRUITING

    Aarhus, 8200, Denmark

  • Esbjerg Og Grindsted Sygehus

    NOT_YET_RECRUITING

    Esbjerg, 6700, Denmark

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