E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severe Atopic Dermatitis |
Dermatitis Atópica de moderada a grave |
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E.1.1.1 | Medical condition in easily understood language |
Atopic Dermatitis, also known as Atopic Eczema |
Dermatitis Atópica, también conocida como eczema atópico. |
|
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 | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
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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 |
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. |
Evaluar la eficacia y la seguridad de upadacitinib en comparación con dupilumab para el tratamiento de pacientes adultos con Dermatitis Atópica de moderada a grave que son candidatos a recibir tratamiento sistémico. |
|
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. Porcentaje de cambio en la escala de valoración numérica (EVN) del peor prurito desde Basal hasta semana 2. Proporción de pacientes que logran una reducción del 100% en EASI (EASI 100) en la semana 16. 3. Proporción de pacientes que logran una reducción del 90% en EASI (EASI 90) en la semana 16. |
|
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 |
• Hombre o mujer entre 12-75 años • Dermatitis atópica activa de moderada a grave definida por EASI, IGA, BSA y prurito. • Candidatos a terapia sistémica o que hayan recibido recientemente terapia sistémica para la dermatitis atópica. |
|
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 |
• Exposición previa a cualquier inhibidor JAK o Dupilumab. • No querer o ser incapaz de discontinuar antes del estudio los tratamientos actuales para DA • Requerir medicación prohibida durante el estudio • Otra enfermedad activa de la piel o infecciones de piel que requieran tratamiento sistémico o que pueden interferir con la evaluación de las lesiones de la dermatitis atópica. • Mujeres embarazadas, dando el pecho o considerando quedarse embarazadas durante el estudio. |
|
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 |
Proporción de pacientes que logran una reducción del 75% del Índice de extensión y gravedad del eczema (EASI 75) en semana 16 |
|
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 |
- Cambio porcentual en EVN del peor prurito entre basal y la semana 16 - Proporción de pacientes que logran una EASI 100 en semana 16 - Proporción de pacientes que logran una EASI 90 en semana 16 |
|
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) | 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 | 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 |
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 | 4 |