E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068462 |
E.1.2 | Term | Eosinophilic asthma |
E.1.2 | System Organ Class | 100000004855 |
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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 |
The primary objective is to assess the efficacy (as measured by the change from baseline in prebronchodilator percent-predicted forced expiratory volume in 1 second [FEV1]) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment. |
L'obiettivo principale è la valutazione dell'efficacia (misurata dalla variazione, rispetto al valore percentuale basale predetto, del VEMS [volume espiratorio forzato in un secondo] di JNJ-38518168 rispetto al placebo in soggetti con asma eosinofilo persistente non adeguatamente controllato nonostante il trattamento attuale. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the safety, efficacy (as measured by improvement in asthma control), tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment. |
Gli obiettivi secondari sono la valutazione di sicurezza, efficacia (misurata dal miglioramento del controllo dell'asma), tollerabilità, farmacocinetica (PK) e farmacodinamica (PD) di JNJ-38518168 rispetto al placebo in soggetti con asma eosinofilo persistente non adeguatamente controllato nonostante il trattamento attuale. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Principal Inclusion Criteria in Lay Language (for a complete list of
inclusion criteria refer to the protocol):
Have a diagnosis of asthma for at least 26 weeks, confirmed by the investigator at Screening Visit 1 -Have been receiving inhaled corticosteroid (ICS) (≤1000 μg/day fluticasone or its equivalent) for at least 12 weeks prior to Screening Visit 1 -At Screening Visit 1, be receiving the same dose of ICS ≤1000 μg/day fluticasone (or equivalent) alone or in conjunction with long-acting β2-agonist
(LABA) and/or montelukast for at least 4 weeks prior to screening with no changes in dose or dosing regimen of any of these therapies during that 4 week period prior to screening -Have an Asthma Control Questionnaire (ACQ) score ≥1.5 at Screening Visit 1 -Have a prebronchodilator forced expiratory volume in
1 second (FEV1) equal to 40% to 80%, inclusive, of predicted value at Screening Visit 1 -Have a ≥12% relative change and ≥200 mL change in FEV1 postbronchodilator at either Screening Visit 1 or 2 |
Criteri di inclusione principali in linguaggio semplice (per l’elenco complete fare riferimento al protocollo)
- Diagnosi di asma da almeno 26 settimane, confermata dallo sperimentatore alla visita di screening 1.
- Assunzione di corticosteroidi per via inalatoria (ICS) (≤ 1000 µg/giorno di fluticasone o equivalente) per almeno 12 settimane prima della visita di screening 1.
- Alla visita di screening 1, assunzione della stessa dose di ICS ≤ 1000 µg/giorno (fluticasone o equivalente) in monoterapia o in associazione a LABA e/o montelukast per almeno 4 settimane prima dello screening senza variazioni della dose o del regime posologico delle due terapie durante tale periodo di 4 settimane precedente allo screening.
- Punteggio del questionario ACQ ≥ 1,5 alla visita di screening 1.
- VEMS prima del broncodilatatore pari al 40-80%, inclusi, del valore predetto alla visita di screening 1.
- Variazione relativa ≥ 12% e variazione del VEMS dopo il broncodilatatore ≥ 200 ml dopo la somministrazione di un massimo di 8 inalazioni di un SABA alla visita di screening 1 o 2.
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E.4 | Principal exclusion criteria |
Principal Exclusion Criteria in Lay Language (for a complete list of
exclusion criteria refer to the protocol):
Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit (ICU) admission due to asthma -Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic
bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease -Has any use of the following asthma therapies: systemic corticosteroids within 6 weeks of Screening Visit 1; oral beta-agonists within 4 weeks of Screening Visit 1;
cromolyns within 4 weeks of Screening Visit 1; leukotriene inhibitors other than montelukast within 4 weeks
of Screening Visit 1; theophylline within 4 weeks of S reening Visit 1; inhaled anti-cholinergic agents within 4 weeks of Screening Visit 1; or omalizumab within 130 days of Screening Visit 1 -Has initiated or discontinued allergen immunotherapy within 12 weeks of Screening Visit 1 -Has smoked within 3 years of Screening Visit 1 or has a history of smoking ≥ 10 pack years -Body-Mass Index (BMI) >32 kg/m2 |
Criteri di esclusione principali in linguaggio semplice (per l’elenco complete fare riferimento al protocollo)
- Ha subito un attacco di asma potenzialmente fatale, con arresto respiratorio, intubazione o ricovero nell'unità di terapia intensiva per asma.
- Ha una storia pregressa di altre patologie respiratorie croniche, incluse, a titolo esemplificativo, pneumopatia cronica ostruttiva (COPD), bronchiolite, bronchiectasia, aspergillosi broncopolmonare allergica (micosi), asma occupazionale, apnea notturna, ipertensione polmonare o qualsiasi altra pneumopatia ostruttiva.
- Utilizza in qualche misura le seguenti terapie per l’asma non consentite:
• corticosteroidi sistemici entro le 6 settimane precedenti alla visita di screening 1;
• beta-agonisti orali entro le 4 settimane precedenti alla visita di screening 1;
• cromolin entro le 4 settimane precedenti alla visita di screening 1;
• inibitori dei leucotrieni diversi dal montelukast entro le 4 settimane precedenti alla visita di screening 1;
• teofillina entro le 4 settimane precedenti alla visita di screening 1;
• agenti anticolinergici per via inalatoria entro le 4 settimane precedenti alla visita di screening 1;
• omalizumab entro i 130 giorni (5 emivite) precedenti alla visita di screening 1;
- Ha iniziato o interrotto l'immunoterapia allergenica entro le 12 settimane precedenti alla visita di screening 1
- Ha fumato entro i 3 anni precedenti alla visita di screening 1 o ha fumato in precedenza ≥ 10 pacchetti all’anno
- Presenta un indice di massa corporea (IMC) > 32 kg/m2.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in prebronchodilator forced expiratory
volume in 1 second (preBD FEV1) |
Modifica dalla baseline del volume espiratorio forzato in un secondo (preBD FEV1) prima del broncodilatatore |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline to Week 16 |
Dalla baseline alla settimana 16 |
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E.5.2 | Secondary end point(s) |
1. Change from baseline in Asthma Control Questionnaire (ACQ)
2. Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)
3. Change from baseline in weekly average of daytime asthma diary
symptom scores
4. Change from baseline in weekly average of nighttime asthma diary symptom scores
5. Change from baseline in weekly average of number of puffs in a day that rescue medication is used |
•Variazione rispetto al basale del questionario ACQ
•Variazione rispetto al basale del VEMS (valore percentuale predetto) dopo il broncodilatatore
•Variazione rispetto al basale della media settimanale del punteggio dei sintomi annotati nel diario sull'asma diurno
•Variazione rispetto al basale della media settimanale del punteggio dei sintomi annotati nel diario sull'asma notturno
•Variazione rispetto al basale del numero medio settimanale di inalazioni giornaliere di farmaci di salvataggio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline to Week 16 |
Dalla baseline alla settimana 16 |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker Analysis |
Analisi dei biomarcatori |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 2 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 |
Canada |
France |
Germany |
Israel |
Italy |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
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last visit of the last subject |
ultima visita dell'ultimo paziente |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 3 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 3 |