| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Nasal polyposis in patients with concomitant asthma. |
polipi nasali in pazienti con poliposi nasale
e concomitante asma |
|
| E.1.1.1 | Medical condition in easily understood language |
| Nasal polyps in patients with asthma |
polipi nasali in pazienti con poliposi nasale
e asma |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10028756 |
| E.1.2 | Term | Nasal polyps |
| E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
In patients with nasal polyps with a polyp size score = 4 at baseline, to
demonstrate a difference in mean change from baseline in polyp size at Week 16, measured by the nasal polyp score (NPS, assessed by nasal endoscopy with central reading), between fevipiprant (150 mg or 450 mg once daily, separately) and placebo |
| Dimostrare una differenza nel cambiamento medio rispetto al basale della dimensione del polipo a 16 settimane, tramite il nasal polyp score (NPS misurato con endoscopio e lettura centralizzata), tra fevipiprant (150mg o 450mg una volta al giorno, separatamente) e placebo, in pazienti con poliposi nasale con uno score relativo alla dimensione del polipo =4 al basale. |
|
| E.2.2 | Secondary objectives of the trial |
-To evaluate the effect on symptoms as measured by the nasal congestion score (NCS) with fevipiprant (150 mg or 450 mg once daily), compared with placebo following 16 weeks of treatment.
-To evaluate the effect on quality of life as measured by the Sino-Nasal Outcome Test - 22 (SNOT-22) with fevipiprant (150 mg or 450 mg once daily), compared with placebo following 16 weeks of treatment.
-To evaluate the effect on Smell as measured by the university of Pennsylvania smell identification test (UPSIT) with fevipiprant (150 mg or 450 mg once daily), compared with placebo following 16 weeks of treatment.
-To evaluate the effect of fevipiprant 150 mg and 450 mg compared with placebo in terms of general safety/tolerability following 16 weeks of treatment. |
-Valutare l’efficacia di fevipiprant (150mg o 450mg una volta al giorno) rispetto a placebo sui sintomi valutati attraverso il nasal congestion score (NCS) dopo 16 settimane di trattamento.
- Valutare l’effetto di fevipiprant (150mg o 450mg una volta al giorno) rispetto a placebo sulla qualità di vita misurata con il Sino-Nasal Outcome Test-22 (SNOT-22) dopo 16 settimane di trattamento.
- Valutare l’effetto di fevipiprant (150mg o 450mg una volta al giorno) rispetto a placebo sull’olfatto mediante il University of Pennsylvania smell identification test (UPSIT) dopo 16 settimane di trattamento.
- Valutare l’effetto di fevipiprant (150mg o 450mg una volta al giorno) rispetto a placebo in termini di sicurezza e tollerabilità dopo 16 settimane di trattamento. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Written informed consent must be obtained before any assessment is performed.
- Patients aged = 18 years with a diagnosis of nasal polyposis with nasal polyp size score = 4 and a minimum score of 2 in each nostril, measured
by nasal endoscopy at screening and prior to randomization on Run in/ Treatment Day 1 (to ensure no reduction in NPS following the use of the mometasone furoate SoC therapy).
- Patients with a concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
- Have been on a stable asthma treatment regimen of at least inhaled corticosteroids (ICS, any dose), alone for at least 6 months prior to Screening or ICS for 6 months prior to Screening with any other required inhaled asthma medication (long-acting bronchodilator (LABA), long-acting muscarinic antagonist (LAMA) added at least 6 weeks prior to Screening. |
- Il consenso informato firmato deve essere ottenuto prima di attuare qualsiasi valutazione dello studio.
- Pazienti con età =18 anni con diagnosi di poliposi nasale con una dimensione del polipo nasale =4 ed un minimo score di 2 per ogni narice,
misurata mediante endoscopia alla visita di screening e prima della randomizzazione il Giorno 1 di Run-in/Trattamento (per essere certi che non vi sia una riduzione del NPS a seguito dell’utilizzo del mometasone furoato come SoC).
- Pazienti con diagnosi concomitante di asma da almeno 6 mesi prima dello screening
- In trattamento stabile per l’asma con almeno corticosteroidi inalatori (ICS, qualsiasi dose), in monoterapia da almeno 6 mesi prima dello screening o
ICS da almeno 6 mesi prima dello screening associati ad altri farmaci inalatori per l’asma (beta2-agonisti a lunga durata d’azione (LABA), anti muscarinici a lunga durata d’azione ( LAMA) da almeno 6 settimane prima dello screening. |
|
| E.4 | Principal exclusion criteria |
-Asthma exacerbation, within 6 weeks prior to Screening that required systemic corticosteroids, hospitalization, or emergency room visit. When
patients experience an exacerbation between screening and the end of the 4 week Run-in period, and prior to randomization, they will be considered screen failures and can be eligible for re-screening only once the required 6 weeks post-exacerbation window has passed.
-Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening
-Use of biologics (omalizumab, mepolizumab, reslisumab, dupilumab, benralizumab etc., for asthma or any other indications) that has potential to
interfere/affect asthma or NP disease progression, within 6 months of the start of the Run-in period.
-Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of Screening or during the Run-in period.
-Any contra-indications to inhaled or nasal steroids e.g. narrow angle glaucoma, or any other as decided by the Investigator.
-History of nasal surgery (including polypectomy) within 6 months prior to screening.
-Patients with control questionnaire - 5 questions (ACQ-5) =1.5 at Screening |
- Riacutizzazione asmatica, nelle 6 settimane precedenti lo screening che abbiano richiesto l’uso di corticosteroidi sistemici, l’ospedalizzazione o una visita in pronto soccorso. Se i pazienti riacutizzano nel periodo tra lo screening e la fine delle 4 settimane di run-in, e prima della randomizzazione, essi devono essere considerati screen failure e possono essere ri-arruolati per un re-screening solo dopo 6 settimane postriacutizzazione;
-Uso cronico/di mantenimento di corticosteroidi orali (OCS) definito come qualsiasi uso continuo di OCS per 1 mese o più nell’anno precedente lo
screening;
- Uso di biologici (omalizumab, mepolizumab, reslizumab, dupilumab,benralizumab etc., per asma o per ogni altra indicazione) che possano potenzialmente interferire/influenzare la progressione dell’asma o della NP, entro 6 mesi dall’inizio del periodo di RUN-in;
- Uso di farmaci per i sintomi sino-nasali (antibiotici con o senza OCS) nei 30 giorni che precedono lo screening o durante il periodo di Run-in;
- Qualsiasi controindicazione all’utilizzo di steroidi inalanti o nasali, per es. il glaucoma ad angolo stretto, o qualsiasi altro come deciso dal clinico;
- Storia di chirurgia nasale (compresa la polipectomia) nei 6 mesi precedenti lo screening;
- Pazienti con unACQ-5 =1.5 allo screening. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Change from baseline in Nasal Polyp Score (assessed by Nasal Endoscopy) following 16 weeks of treatment, compared to placebo |
| Variazione rispetto al basale nel punteggio del polipo nasale (valutato mediante endoscopia nasale) dopo 16 settimane di trattamento, rispetto al placebo |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
--Change from baseline in symptoms score (assessed by Nasal Congestion Score questionnaire) following 16 weeks of treatment, compared to placebo
--Change from baseline in Quality of Life score (assessed using the SNOT- 22 questionnaire) following 16 weeks of treatment, compared to placebo.
--Change from baseline in Smell score (assessed using the University of
Pennsylvania Smell Identification Test) following 16 weeks of treatment, compared to placebo. |
- Cambiamento dal punteggio di base al punteggio sintomatologico (valutato dal questionario Nasal Congestion Score) dopo 16 settimane di trattamento, rispetto al placebo
- Cambiamento dal punteggio di base della qualità della vita (valutato utilizzando il questionario SNOT-22) dopo 16 settimane di trattamento, rispetto al placebo.
- Cambiamento dal basale al punteggio dell'odore (valutato utilizzando l'Università di
Pennsylvania Smell Identification Test) dopo 16 settimane di trattamento, rispetto al placebo. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 16 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Argentina |
| Belgium |
| Canada |
| Czechia |
| Germany |
| Italy |
| Netherlands |
| Poland |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| LVLS: 06-Jul-2020 |
| LVLS: 06-Lug-2020 |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 5 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 15 |
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