Chronic Rhinosinusitis With Nasal PolypsPhase 4NCT07187583
Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
A Phase 4 study testing increased dosing interval of biological therapy in people with Chronic Rhinosinusitis With Nasal Polyps, run by Copenhagen University Hospital, Rigshospitalet at 9 sites in Denmark.
Trial summary
The purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal polyps (CRSwNP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- increased dosing interval of biological therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 9 sitesDenmark
- Study dates
- 5 Jun 2025to 1 Mar 2028
- 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
- ≥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):
- Nasal blockage: present on most days of the week
- Rhinorrhoea/postnasal drip: mucopurulent on most days of the week
Show all 12Show fewer
- Facial pain/pressure: present on most days of the week
- Sense of smell: impaired
- Sleep disturbance or fatigue: present
- Nasal endoscopy: diseased mucosa
- 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.
Who cannot join
- 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)
Show all 9Show 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 - active IVF treatment (please see below)
- Unwillingness to follow the study procedure
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Denmark9 sites, 9 recruiting
- Not yet recruiting
Dept of otorhinolaryngology, Aalborg University Hospital
Aalborg, 9000
Søren Pauli, MD, 004597660000, sbro@rn.dk
Søren Pauli, MD
- Not yet recruiting
Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital
Aarhus, 8200
Kristian B Petersen, MD, 004578450000, krispete@rm.dk
Kristian B Petersen, MD
- Recruiting
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet
Copenhagen, 2100
Christian M. von Buchwald, MD, DMSc, prof., +4535452370, christian.von.buchwald@regionh.dk
christian.von.buchwald@regionh.dk
- Not yet recruiting
Esbjerg Og Grindsted Sygehus
Esbjerg, 6700
Jonas H Andersen, MD, 004579182774, jonas.hjelm.andersen2@rsyd.dk
Jonas H Andersen, MD
- Not yet recruiting
Dept of otorhinolaryngology, Gødstrup Regional Hospital
Herning, 7400
Adnan Madzak, MD, 004578439744, adnan.madzak@auh.rm.dk
Adnan Madzak, MD
- Recruiting
Dept of otorhinolaryngology, Nordsjaellands Hospital
Hillerød, 3400
Grethe B Samuelsen, MD, PhD, 004548293825, grethe.badsberg.samuelsen@regionh.dk
Grethe B Samuelsen, MD, PhD
- Recruiting
Dept of otorhinolaryngology, Sjællands Universitetshospital
Køge, 4600
Bent Ivan Larsen, MD, 004547321401, bele@regionsjaelland.dk
Bent Ivan Larsen, MD
- Not yet recruiting
Dept of otorhinolaryngology, Odense University Hospital
Odense, 5000
Anette Kjeldsen, MD, prof., 004565414314, anette.kjeldsen@rsyd.dk
Anette Kjeldsen, MD, prof
- Not yet recruiting
Dept of otorhinolaryngology, Lillebaelt Hospital
Vejle, 7100
Lars Christian Meyer, MD, 004579405000, lars.christian.meyer@rsyd.dk
Lars Christian Meyer, MD
About this study
The purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal polyps (CRSwNP).
Read the detailed description
This is an investigator-initiated, independent, national multicenter study with a real-world design and Good Clinical Practice (GCP) monitoring. The study is a randomized controlled drug trial investigating the non-inferiority of extended dosing intervals compared with standard treatment for patients with CRSwNP receiving mepolizumab (100 mg) or dupilumab (300 mg) every 4 weeks. Approximately 135 patients will be enrolled from ear, nose and throat departments in all five regions of Denmark. The study duration is approximately 2.5 years, with each patient followed for 52 weeks.
Randomization At inclusion, patients are randomized 1:1 to the intervention or control group. Randomization is computer-based (REDCap).
Control group Continues dosing of mepolizumab or dupilumab every 4 weeks.
Intervention group Increases to a 6-week dosing interval at baseline, and if response to the biological therapy is maintained, increases to 8-week dosing intervals at the follow-up visit at week 26. Thereafter, dosing every 8 weeks is maintained until the patient completes the trial at week 52. In case of worsening of CRSwNP-related symptoms, the patient reverts to the last effective dosing interval.
Clinical visits Clinical follow-ups are conducted at weeks 0, 12, 26, 38, and 52. The visits at weeks 0, 26, and 52 are already planned as a standard part of biological treatment outside the protocol and include endoscopic rhinoscopy, smell testing, and questionnaires: Sinonasal Outcome Test 22 (SNOT-22), Work Productivity and Activity Impairment (WPAI), and Asthma Control Questionnaire (ACQ). The visits at weeks 12 and 38 are study-specific and include patient-reported symptom severity on a Visual Analogue Scale (VAS), endoscopic rhinoscopy, and completion of questionnaires (SNOT-22, WPAI).
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- increased dosing interval of biological therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increased dosing interval of biological therapyDrug
Increasing dosing interval of biological therapy for CRSwNP from every 4 weeks to every 6 weeks and if continued satisfactory response then to every 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard dosing of biological therapy | No intervention | Continues dosing of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) every 4 weeks. |
| Increased dosing interval of biological therapy | Active comparator | Increases to a 6-week dosing interval at baseline - of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) - and if response to therapy is maintained, increases to 8-week dosing intervals at the follow-up visit in week 26. Thereafter, dosing every 8 weeks is maintained until the patient completes the trial at week 52. Receives: Drug: increased dosing interval of biological therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients achieving sustained partly controlled disease after tapering of biologics for CRSwNP
"partly controlled" as defined by presence of 1-2 of the following 7 items:
- Nasal blockage: present on most days of the week
- Rhinorrhoea/postnasal drip: mucopurulent on most days of the week
- Facial pain/pressure: present on most days of the week
- Sense of smell: impaired
- Sleep disturbance or fatigue: present
- Nasal endoscopy: diseased mucosa
- Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment
Measured: from enrollment (week 0) to week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start5 Jun 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With 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
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth M. Stevens, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian von Buchwald, MD, DMSc, prof., Study director, Rigshospitalet, Dept. of Otorhinolaryngology, Head and Neck Surgery & Audiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187583
- Sponsor's protocol ID
- 2024-519758-35-01
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT07187583
- Acronym / sponsor ID
- 2024-519758-35-01
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 23 Sep 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.
The purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal polyps (CRSwNP).
Detailed description
This is an investigator-initiated, independent, national multicenter study with a real-world design and Good Clinical Practice (GCP) monitoring. The study is a randomized controlled drug trial investigating the non-inferiority of extended dosing intervals compared with standard treatment for patients with CRSwNP receiving mepolizumab (100 mg) or dupilumab (300 mg) every 4 weeks. Approximately 135 patients will be enrolled from ear, nose and throat departments in all five regions of Denmark. The study duration is approximately 2.5 years, with each patient followed for 52 weeks.
Randomization At inclusion, patients are randomized 1:1 to the intervention or control group. Randomization is computer-based (REDCap).
Control group Continues dosing of mepolizumab or dupilumab every 4 weeks.
Intervention group Increases to a 6-week dosing interval at baseline, and if response to the biological therapy is maintained, increases to 8-week dosing intervals at the follow-up visit at week 26. Thereafter, dosing every 8 weeks is maintained until the patient completes the trial at week 52. In case of worsening of CRSwNP-related symptoms, the patient reverts to the last effective dosing interval.
Clinical visits Clinical follow-ups are conducted at weeks 0, 12, 26, 38, and 52. The visits at weeks 0, 26, and 52 are already planned as a standard part of biological treatment outside the protocol and include endoscopic rhinoscopy, smell testing, and questionnaires: Sinonasal Outcome Test 22 (SNOT-22), Work Productivity and Activity Impairment (WPAI), and Asthma Control Questionnaire (ACQ). The visits at weeks 12 and 38 are study-specific and include patient-reported symptom severity on a Visual Analogue Scale (VAS), endoscopic rhinoscopy, and completion of questionnaires (SNOT-22, WPAI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dosing of biological therapy | No intervention | –Continues dosing of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) every 4 weeks. |
| Increased dosing interval of biological therapy | Active comparator | Drug: increased dosing interval of biological therapyIncreases to a 6-week dosing interval at baseline - of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) - and if response to therapy is maintained, increases to 8-week dosing intervals at the follow-up visit in week 26. Thereafter, dosing every 8 weeks is maintained until the patient completes the trial at week 52. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥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):
- of which 1-5 will be scored by the patient using VAS (0-10) and noted above 5.
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| increased dosing interval of biological therapyIncreasing dosing interval of biological therapy for CRSwNP from every 4 weeks to every 6 weeks and if continued satisfactory response then to every 8 weeks. | Drug | Increased dosing interval of biological therapy |
Primary outcome
The percentage of patients achieving sustained partly controlled disease after tapering of biologics for CRSwNP
Time frame: from enrollment (week 0) to week 52.
"partly controlled" as defined by presence of 1-2 of the following 7 items: 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
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 23 Sep 2025.
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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.
Christian von Buchwald, MD, DMSc, prof. study director
Rigshospitalet, Dept. of Otorhinolaryngology, Head and Neck Surgery & Audiology
9 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 increased dosing interval of biological therapy in people with Chronic Rhinosinusitis With Nasal Polyps, run by Copenhagen University Hospital, Rigshospitalet at 9 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 12 inclusion and 9 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Elizabeth M. Stevens Saporito, MD (+4535452370, este0027@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients achieving sustained partly controlled disease after tapering of biologics for CRSwNP (time frame: from enrollment (week 0) to week 52.). 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 23 Sep 2025.