E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severe Atopic Dermatitis |
Dermatite atopica da moderata a grave |
|
E.1.1.1 | Medical condition in easily understood language |
Atopic Dermatitis, also known as Atopic Eczema |
Dermatite Atopica, nota anche 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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
|
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 evaluate the efficacy and safety of upadacitinib versus dupilumab for the treatment of adult subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy. |
Valutare l’efficacia e la sicurezza di upadacitinib rispetto a dupilumab per il trattamento di soggetti 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 |
1. Percent change from Baseline to Week 16 in worst pruritus numerical rating scale (NRS) 2. Proportion of subjects achieving a 100% reduction in EASI (EASI 100) at Week 16 3. Proportion of subjects achieving a 90% reduction in EASI (EASI 90) at Week 16 |
1. Variazione percentuale rispetto al Baseline del peggior prurito in base alla scala numerica di valutazione (numerical rating scale, NRS) rilevato alla Settimana 16 2. Percentuale di soggetti che ottengono alla Settimana 16 una riduzione del 100% nel punteggio EASI (risposta EASI 100, Eczema Area and Severity Index) 3. Percentuale di soggetti che ottengono alla Settimana 16 una riduzione del 90% nel punteggio EASI (risposta EASI 90) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects 18 years old and 75 years old • 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 |
1. Variazione percentuale rispetto al Baseline del peggior prurito in base alla scala numerica di valutazione (numerical rating scale, NRS) rilevato alla Settimana 16 2. Percentuale di soggetti che ottengono alla Settimana 16 una riduzione del 100% nel punteggio EASI (risposta EASI 100, Eczema Area and Severity Index) 3. Percentuale di soggetti che ottengono alla Settimana 16 una riduzione del 90% nel punteggio EASI (risposta EASI 90) |
|
E.4 | Principal exclusion criteria |
• Prior exposure to any JAK inhibitor or Dupilumab • 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 |
• Esposizione pregressa a qualsiasi inibitore della proteina JAK o a Dupilumab • Soggetto non in grado o non disposto a interrompere prima dello studio i trattamenti in corso per la dermatite atopica • Necessità di ricevere medicinali proibiti nel corso dello studio clinico • Altre malattie cutanee o infezioni cutanee in fase attiva che richiedono trattamento sistemico oppure che potrebbero interferire con la appropriata valutazione delle lesioni da dermatite atopica • Soggetto di sesso femminile che è in stato di gravidanza, sta allattando oppure pianifica una gravidanza nel corso dello studio clinico |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving a 75% reduction in Eczema Area Severity Index (EASI 75) at Week 16 |
Percentuale di soggetti che ottengono alla Settimana 16 una riduzione del 75% nel punteggio EASI (risposta EASI 75, Eczema Area and Severity Index). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Percent change from baseline to Week 16 in worst pruritus NRS - Proportion of subjects achieving EASI 100 at Week 16 - Proportion of subjects achieving EASI 90 at Week 16 |
- Variazione percentuale rispetto al baseline del peggior prurito in base alla scala NRS, rilevato alla Settimana 16 - Percentuale di soggetti che ottengono la risposta EASI 100 alla Settimana 16 - Percentuale di soggetti che ottengono la risposta EASI 90 alla Settimana 16 |
|
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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 |
Israel |
Malaysia |
New Zealand |
Singapore |
Taiwan |
Ukraine |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 4 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 3 |