Stopping mepolizumab or dupilumab to see if nasal polyps stay in complete remission.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 study enrolls adults with chronic rhinosinusitis with nasal polyps who have been symptom-controlled on mepolizumab (Nucala) or dupilumab (Dupixent). Participants are randomized to either discontinue their biologic or continue as a control and are followed for one year with assessments at baseline and weeks 12, 26, 38, and 52, with the option to contact investigators if symptoms recur. The primary outcome is the proportion of patients who remain in complete remission after stopping treatment, and a secondary objective compares results between the two biologic drugs. The trial is conducted at three Danish centers following national guidance to attempt discontinuation in well-controlled patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rigshospitalet
  Copenhagen, Region H, Denmark Recruiting
• Nordsjællands hospital
  Hillerød, Region H, Denmark Recruiting
• Køge øre næse hals afd
  Køge, Region Sj, Denmark Recruiting
• Dept. of otorhinolaryngology, Odense
  Odense, Region Syd, Denmark Recruiting
• Vejle sygehus
  Vejle, Region S, Denmark Recruiting
• Gødstrup Hospital
  Gødstrup, Denmark Recruiting

Study contacts

• Study coordinator: Kasper Aanæs, md, phd
• Email: kasperaanaes@hotmail.com
• Phone: 60708594

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mepolizumab with or without in-office nasal polypectomy for chronic rhinosinusitis with nasal polyps

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.