Chronic Rhinosinusitis With Nasal PolypsPhase 4MELYSANCT07814924
Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS).
A Phase 4 study testing surgical arm, Mepolizumab 100 MG and combined arm in people with Chronic Rhinosinusitis With Nasal Polyps, run by Instituto de Investigación Marqués de Valdecilla at 7 sites in Spain.
Trial summary
This randomized, controlled multicenter trial will recruit patients aged 18 to 70 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- surgical arm, Mepolizumab 100 MG and combined arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesSpain
- Study dates
- 31 Dec 2024to 31 Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant 18 years of age or older
- Patients with a diagnosis of CRS with polyposis according to the criteria of the EPOS2020 guideline:
- Chronic rhinosinusitis with nasal polyps in adults is defined as presence of two or more symptoms, one of which should be either nasal blockage / obstruction / congestion or nasal discharge (anterior / posterior nasal drip); ± facial pain/pressure; ± reduction or loss of smell; for ≥12 weeks; and either endoscopic signs of nasal polyps, and/or CT changes: mucosal changes within the ostiomeatal complex and/or sinuses.
- Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had ESS and three of the following criteria are required:
- 3.1. Evidence of type 2 inflammation (tissue eos> 10/hpf or blood eos>250, OR total IgE> 100).
- Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant.
Show all 12Show fewer
- 3.2. Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months)
- 3.3. Significantly impaired quality of life (SNOT ≥ 40)
- 3.4. Significant loss of smell (≥7 VAS)
- 3.5. Diagnosis of comorbid asthma
- Basal eosinophil count (BEC) ≥300 cells/µL for surgical naïve patients- or for those who have had surgery and have recurrence . The result of a previous analysis would be valid if it was obtained in a period of time not exceeding one year
- Patients have been informed and signed consent to participate in the study.
Who cannot join
- Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study.
- Unilateral localized secondary CRS (odontogenic, fungal ball, tumor).
- Bilateral diffuse secondary CRS (cystic fibrosis; eosinophilic granulomatosis with polyangiitis-S. de Churg-Strauss-; granulomatosis with polyangiitis-S de Wegener-; primary ciliary dyskinesia; selective immunodeficiencies.
- Pregnancy/ breast feeding.
- Hypersensitivity to mepolizumab or its excipients.
- Patients unable to complete the questionnaire or follow prescribed treatment.
- Patients who are participating in another clinical trial related to polyposis or asthma.
- Previously documented failure with IL-5/IL-5 receptor biologics
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Hospital de Cruces
Barakaldo
Francisco Valcarcel, +34946006000, patxivalcarcel@gmail.com
- Recruiting
Hospital de Jerez
Jerez de la Frontera
Alfonso del cuvillo Bernal, +34956032000, dr.cuvillo@comcadiz.es
- Recruiting
Hospital Puerta del Hierro
Madrid
Antonio Martinez, +34911916000, amruizcoello@gmail.com
- Recruiting
Hospital de Salamanca
Salamanca
Maria gil, +34923291100, mgilmel@saludcastillayleon.es
- Recruiting
Hospital universitario Marques de Valdecilla
Santander, 39006
david lobo duro, +34942315515, david.lobo@scsalud.es
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Serafín Sánchez Gómez, +34955008000, serafin.sanchez.sspa@juntadeandalucia.es
- Recruiting
Hospital de Valladolid
Valladolid
Jaime Santos, +34983420000, jsp002@gmail.com
About this study
Official title: Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
This randomized, controlled multicenter trial will recruit patients aged 18 to 70 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment.
All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include ifferent questionnaires and nasal endoscopy. This trial includes three treatment arms.
Read more
- Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab.
- Medical group (mepolizumab): This group will receive Mepolizumab.
- Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach.
The presence of adverse effects will be assessed in each treatment arm.
Read the detailed description
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and indication for biologic treatment according to the criteria of the EPOS2020 guideline.
Presence of bilateral polyps in a patient who had endoscopic sinus surgery (ESS) (except in cases where the patient is not fit for surgery) and three of the following criteria are required:
- Evidence of type 2 inflammation (tissue eos> 10/hpf* or blood eos>250, OR total IgE> 100).
- Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant.
- Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months)
- Significantly impaired quality of life (SNOT ≥ 40)
- Significant loss of smell (VAS).
- Diagnosis of comorbid asthma
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- surgical arm, Mepolizumab 100 MG, combined arm
- Keywords
- mepolizumab, polypeptomy, in office nasal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical armProcedure or surgery
polypectomy in the office and will not receive mepolizumab treatment.
Mepolizumab 100 MGDrug
will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
combined armOther
Also called polypeptomy + mepolizumab
in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy.
| Study group | Role | What they receive |
|---|---|---|
| surgical arm | Active comparator | This group of patients will undergo nasal polypectomy in the office and will not receive mepolizumab treatment. Receives: Procedure: surgical arm |
| medical arm | Experimental | This group of patients will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization. Receives: Drug: Mepolizumab 100 MG |
| combined arm | Experimental | This group of patients will undergo in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy. Receives: Other: combined arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score at week 52.
SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life/more severe symptoms.
Measured: 12 moths
Secondary outcomes (6)
Change in nasal polyposis severity VAS score at V1, V6, V12.
VAS score ranges from 0 to 100, with higher scores indicating greater symptom severity.
Measured: 1 month, 6 months and 12 months
Change in endoscopic nasal polyp score at V1, V6, V12
Measured: 1 month, 6 months and 12 months
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at V1, V6, V12
Measured: 1 month, 6 months and 12 months
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Measured: 12 months
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Mepolizumab and/or In-office Nasal Polypectomy
Adverse events collected at each study visit and classified as serious or non-serious per protocol definitions, and by causal relationship to treatment (unrelated, possible, probable) as assessed by the investigator.
Measured: 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months
Change from baseline in sinonasal outcome test (SNOT-22) total score at weeks 4 and 24
Measured: 1 month and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start31 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814924
- Sponsor's protocol ID
- MELYSA
- Acronym
- MELYSA
- Status last verified
- May 2026
- First submitted
- 19 Sep 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
- ClinicalTrials.gov ID
- NCT07814924
- Acronym / sponsor ID
- MELYSA / MELYSA
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- mepolizumab, polypeptomy, in office nasal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Sep 2026 (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.
This randomized, controlled multicenter trial will recruit patients aged 18 to 70 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment.
All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include ifferent questionnaires and nasal endoscopy. This trial includes three treatment arms.
- Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab.
- Medical group (mepolizumab): This group will receive Mepolizumab.
- Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach.
The presence of adverse effects will be assessed in each treatment arm.
Detailed description
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and indication for biologic treatment according to the criteria of the EPOS2020 guideline.
Presence of bilateral polyps in a patient who had endoscopic sinus surgery (ESS) (except in cases where the patient is not fit for surgery) and three of the following criteria are required:
- Evidence of type 2 inflammation (tissue eos> 10/hpf* or blood eos>250, OR total IgE> 100).
- Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant.
- Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months)
- Significantly impaired quality of life (SNOT ≥ 40)
- Significant loss of smell (VAS).
- Diagnosis of comorbid asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| surgical arm | Active comparator | Procedure: surgical armThis group of patients will undergo nasal polypectomy in the office and will not receive mepolizumab treatment. |
| medical arm | Experimental | Drug: Mepolizumab 100 MGThis group of patients will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization. |
| combined arm | Experimental | Other: combined armThis group of patients will undergo in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant 18 years of age or older
- Patients with a diagnosis of CRS with polyposis according to the criteria of the EPOS2020 guideline:
- Chronic rhinosinusitis with nasal polyps in adults is defined as presence of two or more symptoms, one of which should be either nasal blockage / obstruction / congestion or nasal discharge (anterior / posterior nasal drip); ± facial pain/pressure; ± reduction or loss of smell; for ≥12 weeks; and either endoscopic signs of nasal polyps, and/or CT changes: mucosal changes within the ostiomeatal complex and/or sinuses.
- Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had ESS and three of the following criteria are required:
- 3.1. Evidence of type 2 inflammation (tissue eos> 10/hpf or blood eos>250, OR total IgE> 100).
Key exclusion criteria (8 listed)
- Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study.
- Unilateral localized secondary CRS (odontogenic, fungal ball, tumor).
- Bilateral diffuse secondary CRS (cystic fibrosis; eosinophilic granulomatosis with polyangiitis-S. de Churg-Strauss-; granulomatosis with polyangiitis-S de Wegener-; primary ciliary dyskinesia; selective immunodeficiencies.
- Pregnancy/ breast feeding.
- Hypersensitivity to mepolizumab or its excipients.
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 |
|---|---|---|
| surgical armpolypectomy in the office and will not receive mepolizumab treatment. | Procedure or surgery | surgical arm |
| Mepolizumab 100 MGwill not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization. | Drug | medical arm |
| combined armAlso: polypeptomy + mepolizumabin-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy. | Other | combined arm |
Primary outcome
the efficacy of mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score at week 52.
Time frame: 12 moths
SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life/more severe symptoms.
6 secondary outcomes
Change in nasal polyposis severity VAS score at V1, V6, V12.
Time frame: 1 month, 6 months and 12 months
Change in endoscopic nasal polyp score at V1, V6, V12
Time frame: 1 month, 6 months and 12 months
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at V1, V6, V12
Time frame: 1 month, 6 months and 12 months
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Time frame: 12 months
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Mepolizumab and/or In-office Nasal Polypectomy
Time frame: 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months
Change from baseline in sinonasal outcome test (SNOT-22) total score at weeks 4 and 24
Time frame: 1 month and 12 months
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
7 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 surgical arm, Mepolizumab 100 MG and combined arm in people with Chronic Rhinosinusitis With Nasal Polyps, run by Instituto de Investigación Marqués de Valdecilla at 7 sites in Spain.
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 8 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy of mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score at week 52. (time frame: 12 moths). 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 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.