Rhinosinusitis ChronicBIOPOSE2NCT06501807
BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry
A study testing Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval). in people with Rhinosinusitis Chronic and Nasal Polyps, run by University Hospital, Lille at 2 sites in France.
Trial summary
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis Chronic, Nasal Polyps
- What is being tested?
- Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jul 2024to 2 Jan 2035
- Phase
- Interventional
- 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
- Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval.
- The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected
Who cannot join
- Oral corticotherapy in the previous month;
- Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP;
- Hypersensitivity to humanized antibodies ;
- Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;
- Pregnant or breast-feeding women;
- Patient without social coverage.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 1 recruiting
- Active, not recruiting
CHU de Lille
Lille
- Recruiting
chu de Lille
Lille
Geoffrey MORTUAIRE, Pr, 03 20 44 59 62, geoffrey.mortuaire@chu-lille.fr
About this study
Official title: Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
Read more
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).
- Conditions
- Rhinosinusitis Chronic, Nasal Polyps
- Being tested
- Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).
- Keywords
- nasal polyp, chronic rhinosinusitis, eosinophil, endotype
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).Drug
Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks).
| Study group | Role | What they receive |
|---|---|---|
| Biologic treatments available | Other | Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval). Receives: Drug: Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of quality of life over 5 years according to the asthmatic status of the patients
Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome
Measured: 5-year follow-up
Secondary outcomes (4)
Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps
Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome
Measured: Evaluation after 6 months of treatment with biologics
Patient reported symptoms measurement
Number of oral corticosteroid treatment courses between each visit (in grammes)
Measured: Month 0, Month 3, Month 6, and every 6 months until 5 years
Time to first surgical procedure since the beginning of biologic treatment
Date and type of sinus surgery between each visit
Measured: MMonth 0, Month 3, Month 6, and every 6 months until 5 years
Blood eosinophil count and total IgE blood concentrations evolution during the course of the 5-year follow-up
Number off cells per mm3
Measured: Month 0, Month 3, Month 6, and every 6 months until 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start11 Jul 2024
- Primary completion2 Sep 2034 (estimated)
- Study completion2 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinosinusitis ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501807
- Sponsor's protocol ID
- 2023_0682
- Acronym
- BIOPOSE2
- Status last verified
- May 2026
- First submitted
- 21 May 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT06501807
- Acronym / sponsor ID
- BIOPOSE2 / 2023_0682
- Conditions
- Rhinosinusitis Chronic, Nasal Polyps
- Keywords
- nasal polyp, chronic rhinosinusitis, eosinophil, endotype
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 2 Sep 2034 (estimated)
- Study completion
- 2 Jan 2035 (estimated)
- First posted
- 15 Jul 2024 (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.
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biologic treatments available | Other | Drug: Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval.
- The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected
Key exclusion criteria (6 listed)
- Oral corticotherapy in the previous month;
- Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP;
- Hypersensitivity to humanized antibodies ;
- Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;
- Pregnant or breast-feeding women;
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 |
|---|---|---|
| Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks). | Drug | Biologic treatments available |
Primary outcome
Comparison of quality of life over 5 years according to the asthmatic status of the patients
Time frame: 5-year follow-up
Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome
4 secondary outcomes
Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps
Time frame: Evaluation after 6 months of treatment with biologics
Patient reported symptoms measurement
Time frame: Month 0, Month 3, Month 6, and every 6 months until 5 years
Time to first surgical procedure since the beginning of biologic treatment
Time frame: MMonth 0, Month 3, Month 6, and every 6 months until 5 years
Blood eosinophil count and total IgE blood concentrations evolution during the course of the 5-year follow-up
Time frame: Month 0, Month 3, Month 6, and every 6 months until 5 years
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 18 May 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval). in people with Rhinosinusitis Chronic and Nasal Polyps, run by University Hospital, Lille at 2 sites in France.
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 2 inclusion and 6 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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 Geoffrey Mortuaire, MD, pHD (0320445675, geoffrey.mortuaire@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of quality of life over 5 years according to the asthmatic status of the patients (time frame: 5-year follow-up). 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 18 May 2026.