E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate and Severe Atopic Dermatitis |
Dermatite Atopica di grado da Moderata e Severa |
|
E.1.1.1 | Medical condition in easily understood language |
Atopic Dermatitis, also known as Atopic Eczema |
Dermatite Atopica conosciuta come Eczema Atopico |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
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 | 10012438 |
E.1.2 | Term | Dermatitis atopic |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue 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 |
To assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy. |
Valutare l’efficacia e la sicurezza di upadacitinib in combinazione con corticosteroidi topici (TCS) per il trattamento di soggetti adolescenti e adulti affetti da dermatite atopica di grado da moderato a grave che sono idonei a ricevere la terapia sistemica. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects 12-75 years of age
• Active moderate to severe atopic dermatitis defined by EASI, IGA, BSA, and pruritus
• Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis
• Able to tolerate topical corticosteroids for atopic dermatitis lesions
|
· Soggetti di ambo i sessi di età compresa fra 12 e 75 anni · Dermatite atopica in fase attiva di grado da moderato a grave in base a parametri EASI, IGA, BSA e prurito · Soggetto idoneo a ricevere la terapia sistemica o che ha di recente avuto necessità della terapia sistemica per la dermatite atopica · Soggetto in grado di tollerare corticosteroidi topici per le lesioni da dermatite atopica |
|
E.4 | Principal exclusion criteria |
• Prior exposure to any JAK inhibitor
• Unable or unwilling to discontinue current AD treatments prior to the study
• Requirement of prohibited medications during the study
• Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
• Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
|
• Pregressa esposizione a qualsiasi inibitore della proteina JAK • Soggetto non disponibile o non in grado di interrompere i trattamenti in corso per la dermatite atopica prima dello studio clinico • Requisiti relativi ai medicinali proibiti nel corso dello studio clinico • Altre patologie cutanee in fase attiva oppure infezioni cutanee che richiedono il trattamento sistemico o che potrebbero interferire con l’appropriata valutazione delle lesioni da dermatite atopica • Soggetto di sesso femminile che è in stato di gravidanza, sta allattando al seno oppure intende iniziare una gravidanza nel corso dello studio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Proportion of subjects achieving validated IGA scale for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from baseline at Week 16;
• Proportion of subjects achieving improvement from baseline of at least 75% on Eczema Area Severity Index (EASI 75) at Week 16. |
• Percentuale di soggetti che ottengono un punteggio alla scala di valutazione vIGA-AD (validated IGA scale for Atopic Dermatitis) pari a 0 oppure 1 con riduzione rispetto al baseline di almeno due punti rilevata alla Settimana 16; • Percentuale di soggetti che ottengono un miglioramento di almeno il 75% rispetto al baseline nel punteggio EASI (risposta EASI 75, Eczema Area and Severity Index) rilevato alla Settimana 16; |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 16
Week 16
|
Settimana 16 Settimana 16 |
|
E.5.2 | Secondary end point(s) |
The multiplicity-adjusted secondary endpoints for EU/EMA regulatory purposes are:
• Proportion of subjects achieving an improvement (reduction) in worst pruritus Numerical Rating Scale (NRS) = 4 from Baseline at Week 16;
• Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16;
• Percent change from Baseline of worst pruritus NRS at Week 16;
• Percent change in EASI score from Baseline at Week 16.
|
Gli Endpoint Secondari Corretti per Molteplicità per le finalità regolatorie EU/EMA sono • Percentuale di soggetti che ottengono un miglioramento (riduzione) rispetto al Baseline = 4 relativo al peggior prurito rilevato mediante scala numerica di valutazione (numerical rating scale, NRS) alla Settimana 16; • Percentuale di soggetti che ottengono una riduzione del 90% nel punteggio EASI (risposta EASI 90) alla Settimana 16; • Variazione percentuale rispetto al Baseline del peggior prurito rilevato mediante scala NRS alla Settimana 16; • Variazione percentuale rispetto al Baseline del punteggio EASI rilevato alla Settimana 16; |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16
Week 16
Week 16
Week 16
|
Settimana 16 Settimana 16 Settimana 16 Settimana 16 |
|
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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 73 |
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 |
Australia |
Canada |
Hong Kong |
Israel |
Japan |
New Zealand |
Puerto Rico |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |