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 | 16.1 |
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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in previous dupilumab asthma study ie DRI12544
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Valutare la sicurezza e la tollerabilità a lungo termine di dupilumab in pazienti affetti da asma che abbiano partecipato al precedente studio clinico sull’asma (DRI12544). |
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E.2.2 | Secondary objectives of the trial |
- Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous dupilumab asthma clinical study.
- Evaluate dupilumab in patients with asthma who participated in previous dupilumab asthma clinical study, with regards to:
* Systemic exposure
* Anti-drug antibodies
* Biomarkers |
Valutare l’efficacia di dupilumab in pazienti affetti da asma che abbiano partecipato ad un precedente studio clinico con dupilumab sull’asma.
Valutare dupilumab in pazienti affetti da asma che abbiano partecipato nel precedente studio clinico sull’asma, con riferimento a:
- Esposizione sistemica
- Anticorpi anti-farmaco
- Biomarcatori
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Eligible patients who have completed a previous dupilumab asthma study (ie, DRI12544) |
Pazienti eleggibili che abbiano completato un precedente studio clinico con dupilumab sull’asma (DRI12544). |
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E.4 | Principal exclusion criteria |
- Patients who did not complete the previous dupilumab asthma study (entire study duration)
- Patients who have experienced hypersensitivity reactions to dupilumab
- Patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratoryassessments before randomization have ruled out an activeinfection
- Medical history of human immunodeficiency virus (HIV) infection
- Known or suspected medical history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent or prolonged infections, as per investigator judgment
- Evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics or antiprotozoals within 4 weeks before Visit 1; significant viral infections within 4 weeks before Visit 1 that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment)
- Patients with any event or laboratory abnormality that, as per investigator judgment, would adversely affect participation of the patient in this study.
- Patients who have traveled to parasitic endemic area within 6 months prior to screening. |
- Pazienti che non abbiano completato il precedente studio clinico con dupilumab sull’asma (per l’intera durata dello studio);
- Pazienti che abbiano sperimentato reazioni di ipersensibilità a dupilumab;
- Pazienti a cui sia stata diagnosticata un’infezione parassitaria attiva, sospetta o ad alto rischio, finchè gli accertamenti clinici o di laboratorio antecedenti alla randomizzazione abbiano escluso un’infezione attiva;
- Anamnesi di Virus da immunodeficienza umana (HIV)
- Nota o sospetta anamnesi di immunosoppressione, inclusa anamnesi di infezioni opportunistiche invasive (ad esempio, tubercolosi, istoplasmosi, listeriosi, coccidioidomicosi, pneumocistosi, aspergillosi) nonostante la risoluzione dell’infezione; o infezioni insolitamente frequenti, ricorrenti o prolungate, a giudizio dello sperimentatore;
- Prova di infezione cronica o acuta che richieda il trattamento con antibatterici, antivirali, antimicotici, antiparassitari o antiprotozoici nelle 4 settimane prima della Visita 1; infezioni virali significative nelle 4 settimane prima della Visita 1 che non abbiano potuto ricevere trattamenti antivirali ( ad esempio, influenza curata solo con trattamento sintomatico);
- Pazienti con qualunque evento o anomalia di laboratorio che, a giudizio del medico sperimentatore, potrebbe negativamente impattare sulla partecipazione del paziente a questo studio clinico;
- Pazienti che abbiano viaggiato in aree parassitarie endemiche nei 6 mesi precedenti allo screening.
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of participants with adverse events |
Numero di partecipanti con eventi avversi |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Vital signs, Clinical laboratory tests, Electrocardiogram, Physical examination - clinically significant changes from baseline
2) Forced expiratory volume in one second - clinically significant changes from baseline
3) Asthma control questionnaire - clinically significant changes from baseline
4) Asthma symptom scores - clinically significant changes from baseline
5) Systemic exposure - changes from baseline
6) Anti-drug antibodies - changes from baseline
7) Biomarkers - changes from baseline |
1) Segni vitali, esami clinici di laboratorio, Elettrocardiogramma, Esami fisico – Significativi cambiamenti clinici dal basale;
2) Volume espiratorio sotto sforzo in 1secondo . Significativi cambiamenti clinici dal basale;
3) Questionario di controllo dell’asma - significativi cambiamenti clinici dal basale;
4) Punteggi dei sintomi dell’asma- significativi cambiamenti clinici dal basale
5) Esposizione sistemica – cambiamenti rispetto al basale;
6)Anticorpi anti-farmaco – cambiamenti rispetto al basale;
7) Biomarcatori – cambiamenti rispetto al basale
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 to 6) Week 112
7) Week 96 |
Da 1 a 6: Settimana 112
7: Settimana 96
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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 | Yes |
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 | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | Yes |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 36 |
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 |
Japan |
New Zealand |
Argentina |
Australia |
Chile |
Korea, Republic of |
Mexico |
Russian Federation |
South Africa |
Turkey |
Ukraine |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 27 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 27 |