E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nasal polyposis in patients with concomitant asthma. |
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E.1.1.1 | Medical condition in easily understood language |
Nasal polyps in patients with asthma |
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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 | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
|
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
--Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score >= 4 with minimum score of 2 in each nostril.
- Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
- Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening. |
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E.4 | Principal exclusion criteria |
-Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit.
--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 for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening.
--Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period.
--Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening.
--History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible.
--Patients with baseline ACQ-5≥1.5
--Patients receiving any medications in the classes listed in Table 6-1 Prohibited Medication should be excluded unless they meet the criteria as specified in Table 6-1.
--Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin 7 days prior to run-in visit. Statin doses less than or equal to these doses as well as other statins will be permitted during the study
--Patients on any statin therapy with a CK level >2 X ULN at Screening Visit |
|
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 |
|
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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 |
Czech Republic |
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
|
|
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 | 15 |
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 |