Nasal PolypsPhase 3NAPPREBNCT04185012
NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab
A Phase 3 study testing Benralizumab in people with Nasal Polyps, run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial summary
Background and rationale: Phase III-b study. Population and patient selection criteria: Adult patients with Chronic Rhinosinusitis with Nasal Polyps (allergic and non-allergic) requiring at least 1000 mg oral prednisone over the previous twelve months to control symptoms of rhinosinusitis, and with: Nasal polyps score… 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?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 24 Feb 2020to 28 Jun 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with Chronic Rhinosinusitis with Nasal Polyps (allergic and non-allergic) requiring at least 1000 mg oral prednisone over the previous twelve months to control symptoms of rhinosinusitis, and with:
- Nasal polyps score (Meltzer et al.) > 5
- Symptoms VAS scores (for nasal obstruction, hyposmia, post-nasal drip, sneezing, rhinorrea; 0-10 for each symptom) > 24
- Provision of informed consent prior to any study specific procedure
Who cannot join
- Patients < 18 years age
- Pregnant women
- Biologic therapy in the past 6 months (or at least a period corresponding to 5 half-life of used drugs) (eg: omalizumab, mepolizumab, reslizumab, dupilumab)
- Previous treatment with Benralizumab
- Known hypersensitivity to benralizumab or any of its excipients
- Immunosuppression other than oral steroids in the past 3 months
Show all 24Show fewer
- Allergen immunotherapy in the past 6 months
- Serious life threatening cardiopulmonary disorders
- Systemic immunologic disorder in the last 12 months
- Positive history for malignant tumors ever in patient's life
- Patients with conditions or concomitant diseases making them non evaluable at visit 1 or for the primary efficacy endpoint:
- Ongoing rhinitis medicamentosa
- Nasal septal deviation occluding at least one nostril
- Acute sinusitis, nasal infection, upper respiratory infections
- Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis
- Eosinophilic Granulomatosis with Polyangiitis (previously named Churg-Strauss Syndrome)
- Granulomatosis with Polyangiitis (previously named Wegener's granulomatosis)
- Young's Syndrome
- Kartagener's Syndrome
- all ciliary dyskinesia
- Cystic Fibrosis
- Systemic corticosteroid treatment for other chronic conditions (i.e.: autoimmune disorders, tumors,….)
- Evidence of active systemic immunedepression (i.e..: primary or secondary immunodeficiency)
- Patients with severe asthma, defined according to ERS/ATS definition
Trial locations and contacts
1 site in 1 country.
About this study
Background and rationale:
Phase III-b study.
Read more
Population and patient selection criteria: Adult patients with Chronic Rhinosinusitis with Nasal Polyps (allergic and non-allergic) requiring at least 1000 mg oral prednisone over the previous twelve months to control symptoms of rhinosinusitis, and with:
- Nasal polyps score (Meltzer et al.) ≥ 5
- Symptoms VAS scores (for nasal obstruction, hyposmia, post-nasal drip, sneezing, rhinorrea; 0-10 for each symptom) > 24 Sample size: 20 subjects.
Study design and study duration:
This is a pilot, prospective, double-blind placebo-controlled (DBPC) phase III-b trial with Benralizumab 30 mg administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks (followed up at 32 and 52 weeks) in patients with chronic rhinosinusinusitis with nasal polyps (CRSwNP).
Description of study treatment/product/intervention: Benralizumab, 30 mg subcutaneously every 4 week for the first 3 doses, and then every 8 weeks.
Objectives:
- Primary objective: To assess the clinical efficacy of Benralizumab on CRSwNP at week 24 (vs baseline) after the beginning of treatment, and to correlate the presence of baseline biomarkers with nasal polyp (NP) score improvement, in order to identify any possible predictive biomarker of response to Benralizumab.
- Secondary objective: In the follow up phase we will monitor all the biomarkers at 32 and 52 weeks , this monitoring will ascertain if any of those will predict relapse of nasal polyps and consequently when Benralizumab treatment has to be reinstalled.
- Safety objective: To evaluate the safety and tolerability of Benralizumab in patients with CRSwNP
Statistical methods, data analysis: Descriptive analysis of all collected variables at all time-points will be performed. Patients will be classified into "responders" and "non responders", for primary endopoint variable. Continuous variables will be evaluated with the normality test of Kolmogorov-Smirnov and compared with ANOVA or the Mann-Whitney test, depending on the normality of distribution. Categorical variables will be compared using Fisher's exact test.
Ethical considerations: The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable regulatory requirements and the Sponsor policy on Bioethics and Human Biological Samples.
- Conditions
- Nasal Polyps
- Being tested
- Benralizumab, Placebo
- Keywords
- Benralizumab, Biomarkers, Eosinophils
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabBiological
Benralizumab 30 mg administered subcutaneously Q4W for the first 3 doses and then Q8W, for a 16 weeks treatment-period
PlaceboBiological
Placebo administered subcutaneously Q4W for the first 3 doses and then Q8W, for a 16 weeks treatment-period
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Experimental | Benralizumab 30 mg administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks Receives: Biological: Benralizumab |
| Placebo | Placebo comparator | Placebo administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant reduction of the Nasal polyps Score (range: 0-8; higher values mean larger nasal polyps size)
score reduction of 1.5
Measured: at week 24 (vs baseline)
Secondary outcomes (3)
Reduction in Lund-MacKay Score (range: 0-24; higher values mean larger nasal polyps extension)
>50% of baseline
Measured: at week 24 (vs baseline)
Improvement of Sino-Nasal Outcome Test (SNOT-22; range: 0-110; higher values mean poorer disease-related quality of life)
>40% of baseline
Measured: at week 24 (vs baseline)
Improvement of smell Visual Analogue Scale (VAS; range: 0-10; higher values mean worse smell)
>50% of baseline
Measured: at week 24 (vs baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start24 Feb 2020
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled clinical trial. Patients will be divided in two arms with 1:1 randomization to Treatment or Placebo.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185012
- Sponsor's protocol ID
- NAPPREB
- Acronym
- NAPPREB
- Status last verified
- Oct 2024
- First submitted
- 29 Nov 2019
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.
PubMed 33710614
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab
- ClinicalTrials.gov ID
- NCT04185012
- Acronym / sponsor ID
- NAPPREB / NAPPREB
- Conditions
- Nasal Polyps
- Keywords
- Benralizumab, Biomarkers, Eosinophils
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 4 Dec 2019 (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.
Background and rationale:
Phase III-b study.
Population and patient selection criteria: Adult patients with Chronic Rhinosinusitis with Nasal Polyps (allergic and non-allergic) requiring at least 1000 mg oral prednisone over the previous twelve months to control symptoms of rhinosinusitis, and with:
- Nasal polyps score (Meltzer et al.) ≥ 5
- Symptoms VAS scores (for nasal obstruction, hyposmia, post-nasal drip, sneezing, rhinorrea; 0-10 for each symptom) > 24 Sample size: 20 subjects.
Study design and study duration:
This is a pilot, prospective, double-blind placebo-controlled (DBPC) phase III-b trial with Benralizumab 30 mg administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks (followed up at 32 and 52 weeks) in patients with chronic rhinosinusinusitis with nasal polyps (CRSwNP).
Description of study treatment/product/intervention: Benralizumab, 30 mg subcutaneously every 4 week for the first 3 doses, and then every 8 weeks.
Objectives:
- Primary objective: To assess the clinical efficacy of Benralizumab on CRSwNP at week 24 (vs baseline) after the beginning of treatment, and to correlate the presence of baseline biomarkers with nasal polyp (NP) score improvement, in order to identify any possible predictive biomarker of response to Benralizumab.
- Secondary objective: In the follow up phase we will monitor all the biomarkers at 32 and 52 weeks , this monitoring will ascertain if any of those will predict relapse of nasal polyps and consequently when Benralizumab treatment has to be reinstalled.
- Safety objective: To evaluate the safety and tolerability of Benralizumab in patients with CRSwNP
Statistical methods, data analysis: Descriptive analysis of all collected variables at all time-points will be performed. Patients will be classified into "responders" and "non responders", for primary endopoint variable. Continuous variables will be evaluated with the normality test of Kolmogorov-Smirnov and compared with ANOVA or the Mann-Whitney test, depending on the normality of distribution. Categorical variables will be compared using Fisher's exact test.
Ethical considerations: The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable regulatory requirements and the Sponsor policy on Bioethics and Human Biological Samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled clinical trial. Patients will be divided in two arms with 1:1 randomization to Treatment or Placebo.
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Experimental | Biological: BenralizumabBenralizumab 30 mg administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo administered subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks, for a treatment-period of 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with Chronic Rhinosinusitis with Nasal Polyps (allergic and non-allergic) requiring at least 1000 mg oral prednisone over the previous twelve months to control symptoms of rhinosinusitis, and with:
- Nasal polyps score (Meltzer et al.) > 5
- Symptoms VAS scores (for nasal obstruction, hyposmia, post-nasal drip, sneezing, rhinorrea; 0-10 for each symptom) > 24
- Provision of informed consent prior to any study specific procedure
Key exclusion criteria (24 listed)
- Patients < 18 years age
- Pregnant women
- Biologic therapy in the past 6 months (or at least a period corresponding to 5 half-life of used drugs) (eg: omalizumab, mepolizumab, reslizumab, dupilumab)
- Previous treatment with Benralizumab
- Known hypersensitivity to benralizumab or any of 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 |
|---|---|---|
| BenralizumabBenralizumab 30 mg administered subcutaneously Q4W for the first 3 doses and then Q8W, for a 16 weeks treatment-period | Biological | Benralizumab |
| PlaceboPlacebo administered subcutaneously Q4W for the first 3 doses and then Q8W, for a 16 weeks treatment-period | Biological | Placebo |
Primary outcome
Significant reduction of the Nasal polyps Score (range: 0-8; higher values mean larger nasal polyps size)
Time frame: at week 24 (vs baseline)
score reduction of 1.5
3 secondary outcomes
Reduction in Lund-MacKay Score (range: 0-24; higher values mean larger nasal polyps extension)
Time frame: at week 24 (vs baseline)
Improvement of Sino-Nasal Outcome Test (SNOT-22; range: 0-110; higher values mean poorer disease-related quality of life)
Time frame: at week 24 (vs baseline)
Improvement of smell Visual Analogue Scale (VAS; range: 0-10; higher values mean worse smell)
Time frame: at week 24 (vs baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Derived from this study: PubMed 33710614Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benralizumab in people with Nasal Polyps, run by Humanitas Clinical and Research Center at 1 site in Italy.
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 4 inclusion and 24 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant reduction of the Nasal polyps Score (range: 0-8; higher values mean larger nasal polyps size) (time frame: at week 24 (vs baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185012, which also lists 1 linked publication.
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 31 Oct 2024.