Complete Remission After Treatment With Biologics for Nasal Polyps

NCT07268313 | Recruiting Phase 4 DMC

• 1 other identifier: Rigshospitalet-ENT-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 6

Brief Summary

In this RCT the investigators randomize patients who are treated with biologic treatment (Nucala or Dupixent) due to nasal polyps and have controlled disease within the last year to either stop treatment og continue as a control group.

Conditions

Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Number of patients who can continue being in complete remission being out of biologic treatment.

  It is known that some asthma patients after years of treatment can stop taking biologics without regaining symptoms. Further, studies have shown that a lot of patients can be without symptoms taking biologics every 12th week. The definition of being in control, also called complete remission, is: not scoring higher than 5 (range 0 -10) on a Visual Analogue Scale (VAS) on nasal blockage, rhinorrhea, facial pressure, decreased smell or sleep; 0 being no symptoms and 10 being worst imaginable further no antibiotics, systemic steroids or surgery should be needed and the nasal examination must also be unchanged. The primary outcome is to observe how many, if any, patients can stop their biologic treatment still being in complete remission. This is evaluated by VAS questionnaires and nasal endoscopy every third month or even more frequent if the patient has symptoms. This is compared with the control group that has the same follow-up regime.

  One year observaton

Secondary Outcomes (1)

• Is there any difference in what drug (Dupixent or Nucala) the patient was treated with before they stopped in the ability to obtain complete remission

  One year observation

Study Arms (4)

Arm 1: Continue Drug D

ACTIVE COMPARATOR

Participants continue their usual treatment with Drug Dupi throughout the study.

Drug: DUPIXENT®

Arm 2: Stop Drug D

EXPERIMENTAL

Participants discontinue Drug Dupi at baseline and receive no active treatment during the study.

Other: Dupi discontinuation

Arm 3: Continue Drug M

ACTIVE COMPARATOR

Participants continue their usual treatment with Drug Mepo throughout the study.

Drug: NUCALA®

Arm 4: Stop Drug M

EXPERIMENTAL

Participants discontinue Drug Mepo at baseline and receive no active treatment during the study.

Other: Mepo discontinuation

Interventions

Mepo discontinuation OTHER

Stop taking Nucala at baseline; no substitute is given

Arm 4: Stop Drug M

DUPIXENT® DRUG

Continue Dupixent

Arm 1: Continue Drug D

NUCALA® DRUG

"Continue Nucala

Arm 3: Continue Drug M

Dupi discontinuation OTHER

Stop taking Dupixent at baseline; no substitute is given

Arm 2: Stop Drug D

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (6)

Rigshospitalet

Copenhagen, Region H, 2100, Denmark

RECRUITING

Nordsjællands hospital

Hillerød, Region H, 3400, Denmark

RECRUITING

Køge øre næse hals afd

Køge, Region Sj, 4600, Denmark

RECRUITING

Dept. of otorhinolaryngology, Odense

Odense, Region Syd, 5000, Denmark

RECRUITING

Vejle sygehus

Vejle, Region S, 7100, Denmark

RECRUITING

Gødstrup Hospital

Gødstrup, Denmark

RECRUITING

MeSH Terms

Conditions

Nasal Polyps

Interventions

dupilumab; mepolizumab

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kasper Aanæs, md, phd

CONTACT

60708594; kasperaanaes@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, phd., Principal investigator, associated professor

Model Details: One intervention group stops treatment (but starts again if any symptom returns), one control group

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: December 5, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)