Rhinosinusitis ChronicPhase 4MELYSANCT05923047
Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
A Phase 4 study testing Mepolizumab and Polypeptomy in people with Rhinosinusitis Chronic and Polyp, Nasal, 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 7 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 100 years
- Conditions the study is for
- Rhinosinusitis Chronic, Polyp, Nasal
- What is being tested?
- Mepolizumab and Polypeptomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesSpain
- Study dates
- 1 Sep 2023to 1 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 100 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 (except in cases where the patient is not fit for surgery, see bellow) 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).
- Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months)
Show all 12Show fewer
- Significantly impaired quality of life (SNOT ≥ 40)
- Significant loss of smell (≥7 VAS)
- Diagnosis of comorbid asthma
- Basal eosinophil count (BEC) ≥300 cells/μL for surgical naïve patients- only those not fit for surgery (major criteria) or for those who have had surgery and have recurrence (minor criteria).
- Patients have been informed and signed consent to participate in the study.
- For those patients not suitable for surgery, the criteria of the EUFOREA guidelines for indication of biological treatment will be used (4 criteria, one of them being ≥300 cells/μL BEC).
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 it's 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.
7 sites in 1 country
Spain7 sites
Hospital de Curces
Bilbao
Francisco Valcarcel
Hospital de Jerez
Jerez de la Frontera
Alfonso cuvillo
Hospital Puerta del Hierro
Madrid
Antonio Martinez
HUCA
Oviedo
Jose Luis Llorente
Hospital Universitario Marques de Valdecilla
Santander, 39011
david Lobo, david.lobo@scsalud.es
Hospital Virgen Macarena
Seville
serafin sanchez
Hospital Valladolid
Valladolid
Jaime santos
About this study
This randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 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 different 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.
- Conditions
- Rhinosinusitis Chronic, Polyp, Nasal
- Being tested
- Mepolizumab, Polypeptomy
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
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
PolypeptomyProcedure or surgery
This group will undergone in-office nasal polypectomy.
| Study group | Role | What they receive |
|---|---|---|
| Combined group | Experimental | In-office nasal polypectomy group with mepolizumab Receives: Drug: Mepolizumab |
| Medical group | Experimental | (mepolizumab) Receives: Drug: Mepolizumab |
| Surgical group | Active comparator | In-office nasal polypectomy Receives: Procedure: Polypeptomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score
Measured: up to 52 weeks
Secondary outcomes (6)
Change in nasal polyposis severity VAS score at 4 weeks, 6 months, 12 months
Measured: up to 52 weeks
Change in endoscopic nasal polyp score at 4 weeks, 6 months, 12 months
Measured: up to 52 weeks
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at 4 weeks, 6 months, 12 months
Measured: up to 52 weeks
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Measured: up to 52 weeks
Number of participants with mepolizumab and in-office nasal polypectomy related adverse events
Measured: up to 52 weeks
Change from baseline in sinonasal outcome test
The minimum value is 0 and maximum value is 110
Measured: up to 4 and 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (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.
- 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
- This trial includes three treatment arms. 1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab. 2. Medical group (mepolizumab): This group will receive Mepolizumab. 3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy.
- 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
- NCT05923047
- Sponsor's protocol ID
- IDIVAL
- Acronym
- MELYSA
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
- ClinicalTrials.gov ID
- NCT05923047
- Acronym / sponsor ID
- MELYSA / IDIVAL
- Conditions
- Rhinosinusitis Chronic, Polyp, Nasal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 28 Jun 2023 (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 7 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 different 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This trial includes three treatment arms. 1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab. 2. Medical group (mepolizumab): This group will receive Mepolizumab. 3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy.
| Arm | Type | Receives |
|---|---|---|
| Combined group | Experimental | Drug: MepolizumabIn-office nasal polypectomy group with mepolizumab |
| Medical group | Experimental | Drug: Mepolizumab(mepolizumab) |
| Surgical group | Active comparator | Procedure: PolypeptomyIn-office nasal polypectomy |
Who may qualify
- Ages
- 18 to 100 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 (except in cases where the patient is not fit for surgery, see bellow) 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).
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 it's 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 |
|---|---|---|
| MepolizumabPatients 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 | Drug | Combined group, Medical group |
| PolypeptomyThis group will undergone in-office nasal polypectomy. | Procedure or surgery | Surgical group |
Primary outcome
Mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score
Time frame: up to 52 weeks
6 secondary outcomes
Change in nasal polyposis severity VAS score at 4 weeks, 6 months, 12 months
Time frame: up to 52 weeks
Change in endoscopic nasal polyp score at 4 weeks, 6 months, 12 months
Time frame: up to 52 weeks
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at 4 weeks, 6 months, 12 months
Time frame: up to 52 weeks
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Time frame: up to 52 weeks
Number of participants with mepolizumab and in-office nasal polypectomy related adverse events
Time frame: up to 52 weeks
Change from baseline in sinonasal outcome test
Time frame: up to 4 and 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Mepolizumab and Polypeptomy in people with Rhinosinusitis Chronic and Polyp, Nasal, 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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?
Results are not available in the source record.
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?
Mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score (time frame: up to 52 weeks). 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 28 Jun 2023.