Nasal PolypsPhase 4NCT07268313
Complete Remission After Treatment With Biologics for Nasal Polyps
A Phase 4 study testing DUPIXENT®, NUCALA® and Dupi discontinuation in people with Nasal Polyps, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- DUPIXENT®, NUCALA® and Dupi discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 6 sitesDenmark
- Study dates
- 3 Apr 2025to 1 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5.1 Inclusion criteria (all must be fulfilled)
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Region H, 2100
Kasper aanæs, md, phd, 60708594
- Recruiting
Gødstrup Hospital
Gødstrup
Adnan Madzak
- Recruiting
Nordsjællands hospital
Hillerød, Region H, 3400
Grethe Samuelsen, 48293825, noh.nordsjaellands-hospital@regionh.dk
- Recruiting
Køge øre næse hals afd
Køge, Region Sj, 4600
Bent Ivan Larsen
- Recruiting
Dept. of otorhinolaryngology, Odense
Odense, Region Syd, 5000
Anette Drøhse Kjeldsen, 65414314, anette.kjeldsen@rsyd.dk
- Recruiting
Vejle sygehus
Vejle, Region S, 7100
Lars Christian Meyer, 79405000, lars.christian.meyer@rsyd.dk
About this study
Official title: English Title: Complete Remission Study Subtitle: Discontinuation of Mepolizumab or Dupilumab After at Least 12 Months Without Symptoms in Patients With Severe Chronic Rhinosinusitis With Polyps - a National Danish RCT Study
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.
Read the detailed description
11 Protocol Synopsis 11.1. EU trial number and full trial title: 2024- 5196285-25-00 English title: Complete remission study Subtitle: Discontinuation of Mepolizumab or Dupilumab after at least 12 months without symptoms in patients with severe Chronic rhinosinusitis with polyps - a National Danish RCT study.
11.2. Rationale Specify background and hypothesis of the trial. The Danish Medicines Council has decided that well-controlled patients with nasal polyps should try to cease the medication after two years of treatment with biologics (Mepolizumab or Dupilumab). The investigators find this better to do in a RCT. Based on the experience from asthma patients this could be done in some patients without the symptoms reoccur.
11.3. Objective Specify the main and secondary objectives of the trial. The main objective is to find the percentage of patients in complete remission (no or few symptoms) who can cease the biologic treatment and keep being in remission. The secondary objective is to observe if one or the other drug is more likely to give this result.
11.4. \& 11.5 Main and secondary trial endpoints: The main endpoint is to monitor the percentage of patients who do not have recurrence of their sino-nasal symptoms when they cease medicine. This is evaluated at baseline and after 12,26,38,52 weeks, however, the patients can contact the investigators at any time if symptoms reoccur. A control group is included and it is assumed that patients kept on treatment will keep being in complete remission. No adverse effects are expected, thus no new medication is started.
11.6. Trial design: Non-blinded, prospective RCT. Half the included patients will keep their treatment unchanged (control-group) the other half will stop the biological treatment (everything else unchanged). Every individual participant will have a 52-week follow-up period. If a participant in the trial group gets symptoms and feel partly uncontrolled they will start treatment again with same drug, dose and interval as before the cease.
11.7. Trial population: Patients over 18 years of age, who have been on hospital administrated biologic treatment for at least 1½ year and have been in remission for at least a year.
11.8. Interventions: The participants are randomized into two groups: one group (33 patients) will be the control group with no change in their treatment, the other group (33 patients) will cease treatment.
11.9. Ethical considerations. The investigators have very few ethical concerns by conducting this study. It is highly unlikely that any side effects will occur, thus there is no suspicion that reducing dose of biologics gives risks of side effects.
Further, none of the examinations or questionnaires are add-on to the examinations that the patients must go through when being in biologic treatment.
The investigators only concern is that some patients will experience recurrence of sino-nasal and/or asthma symptoms when stopping the biologic medicine. However, there is a plan for handling this safely. Lastly, it should also be kept in mind that the Danish medicines council recommends trying to stop the treatment, thus the investigators find it better to do this under RCT conditions.
- Conditions
- Nasal Polyps
- Being tested
- DUPIXENT®, NUCALA®, Dupi discontinuation, Mepo discontinuation
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUPIXENT®Drug
Continue Dupixent
NUCALA®Drug
"Continue Nucala
Dupi discontinuationOther
Stop taking Dupixent at baseline; no substitute is given
Mepo discontinuationOther
Stop taking Nucala at baseline; no substitute is given
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Continue Drug D | Active comparator | Participants continue their usual treatment with Drug Dupi throughout the study. Receives: Drug: DUPIXENT® |
| Arm 2: Stop Drug D | Experimental | Participants discontinue Drug Dupi at baseline and receive no active treatment during the study. Receives: Other: Dupi discontinuation |
| Arm 3: Continue Drug M | Active comparator | Participants continue their usual treatment with Drug Mepo throughout the study. Receives: Drug: NUCALA® |
| Arm 4: Stop Drug M | Experimental | Participants discontinue Drug Mepo at baseline and receive no active treatment during the study. Receives: Other: Mepo discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
When randomizing the patients they are stratified for what drug, they are treated with - Dupixent or Nucala. If some of the patients can be out of treatment for a year, thereby obtain-ing complete remission. Thus, the secondary outcome is to describe the percentage of pa-tients with complete remission who started on Dupixent and Nucala, respectively.
Measured: One year observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start3 Apr 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One intervention group stops treatment (but starts again if any symptom returns), one control group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasper Aanaes, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268313
- Sponsor's protocol ID
- Rigshospitalet-ENT-1
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- English Title: Complete Remission Study Subtitle: Discontinuation of Mepolizumab or Dupilumab After at Least 12 Months Without Symptoms in Patients With Severe Chronic Rhinosinusitis With Polyps - a National Danish RCT Study
- ClinicalTrials.gov ID
- NCT07268313
- Acronym / sponsor ID
- Rigshospitalet-ENT-1
- Conditions
- Nasal Polyps
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
11 Protocol Synopsis 11.1. EU trial number and full trial title: 2024- 5196285-25-00 English title: Complete remission study Subtitle: Discontinuation of Mepolizumab or Dupilumab after at least 12 months without symptoms in patients with severe Chronic rhinosinusitis with polyps - a National Danish RCT study.
11.2. Rationale Specify background and hypothesis of the trial. The Danish Medicines Council has decided that well-controlled patients with nasal polyps should try to cease the medication after two years of treatment with biologics (Mepolizumab or Dupilumab). The investigators find this better to do in a RCT. Based on the experience from asthma patients this could be done in some patients without the symptoms reoccur.
11.3. Objective Specify the main and secondary objectives of the trial. The main objective is to find the percentage of patients in complete remission (no or few symptoms) who can cease the biologic treatment and keep being in remission. The secondary objective is to observe if one or the other drug is more likely to give this result.
11.4. \& 11.5 Main and secondary trial endpoints: The main endpoint is to monitor the percentage of patients who do not have recurrence of their sino-nasal symptoms when they cease medicine. This is evaluated at baseline and after 12,26,38,52 weeks, however, the patients can contact the investigators at any time if symptoms reoccur. A control group is included and it is assumed that patients kept on treatment will keep being in complete remission. No adverse effects are expected, thus no new medication is started.
11.6. Trial design: Non-blinded, prospective RCT. Half the included patients will keep their treatment unchanged (control-group) the other half will stop the biological treatment (everything else unchanged). Every individual participant will have a 52-week follow-up period. If a participant in the trial group gets symptoms and feel partly uncontrolled they will start treatment again with same drug, dose and interval as before the cease.
11.7. Trial population: Patients over 18 years of age, who have been on hospital administrated biologic treatment for at least 1½ year and have been in remission for at least a year.
11.8. Interventions: The participants are randomized into two groups: one group (33 patients) will be the control group with no change in their treatment, the other group (33 patients) will cease treatment.
11.9. Ethical considerations. The investigators have very few ethical concerns by conducting this study. It is highly unlikely that any side effects will occur, thus there is no suspicion that reducing dose of biologics gives risks of side effects.
Further, none of the examinations or questionnaires are add-on to the examinations that the patients must go through when being in biologic treatment.
The investigators only concern is that some patients will experience recurrence of sino-nasal and/or asthma symptoms when stopping the biologic medicine. However, there is a plan for handling this safely. Lastly, it should also be kept in mind that the Danish medicines council recommends trying to stop the treatment, thus the investigators find it better to do this under RCT conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- One intervention group stops treatment (but starts again if any symptom returns), one control group
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Continue Drug D | Active comparator | Drug: DUPIXENT®Participants continue their usual treatment with Drug Dupi throughout the study. |
| Arm 2: Stop Drug D | Experimental | Other: Dupi discontinuationParticipants discontinue Drug Dupi at baseline and receive no active treatment during the study. |
| Arm 3: Continue Drug M | Active comparator | Drug: NUCALA®Participants continue their usual treatment with Drug Mepo throughout the study. |
| Arm 4: Stop Drug M | Experimental | Other: Mepo discontinuationParticipants discontinue Drug Mepo at baseline and receive no active treatment during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 5.1 Inclusion criteria (all must be fulfilled)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DUPIXENT®Continue Dupixent | Drug | Arm 1: Continue Drug D |
| NUCALA®"Continue Nucala | Drug | Arm 3: Continue Drug M |
| Dupi discontinuationStop taking Dupixent at baseline; no substitute is given | Other | Arm 2: Stop Drug D |
| Mepo discontinuationStop taking Nucala at baseline; no substitute is given | Other | Arm 4: Stop Drug M |
Primary outcome
Number of patients who can continue being in complete remission being out of biologic treatment.
Time frame: One year observaton
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.
1 secondary outcome
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
Time frame: One year observation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Nasal Polyps
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DUPIXENT®, NUCALA® and Dupi discontinuation in people with Nasal Polyps, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kasper Aanæs, md, phd (60708594, kasperaanaes@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who can continue being in complete remission being out of biologic treatment. (time frame: One year observaton). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.