E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate and Severe Atopic Dermatitis |
Dermatitis atópica moderada y grave |
|
E.1.1.1 | Medical condition in easily understood language |
Atopic Dermatitis, also known as Atopic Eczema |
Dermatitis atópica, también conocida como eccema atópico |
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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 |
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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 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. |
Evaluar la eficacia y la seguridad de upadacitinib combinado con corticosteroides tópicos (CTs) para el tratamiento de adolescentes y adultos con DA de moderada a grave que son candidatos a tratamiento sistémico. |
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E.2.2 | Secondary objectives of the trial |
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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 |
• 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. • Capaz de tolerar corticosteroides tópicos en las lesiones de dermatitis atópica. |
|
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 |
• Exposición previa a cualquier inhibidor JAK. • 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. |
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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. |
•Proporción de pacientes que logran una evaluación global por el investigador validada de la dermatitis atópica (vIGA-AD) de 0 o 1 con una reducción de al menos dos grados entre el momento basal a la semana 16. •Proporción de pacientes que logran una reducción de al menos el 75 % del Índice de extensión y gravedad del eccema (EASI 75) entre el momento basal a la semana 16. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 16 Week 16 |
Semana 16 Semana 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. |
Los objetivos secundarios ajustados por multiplicidad con propósitos regulatorios de UE/AEM son: • Proporción de pacientes que logran una mejoría (reducción) en la escala de valoración numérica (EVN) del peor prurito ≥ 4 entre el momento basal a semana 16; • Proporción de pacientes que logran una reducción del 90% en EASI (EASI 90) a la semana 16; • Cambio porcentual en EVN del peor prurito entre el momento basal a la semana 16; • Cambio porcentual en resultado EASI entre el momento basal a la semana 16. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 Week 16 Week 16 Week 16 |
Semana 16 Semana 16 Semana 16 Semana 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 | 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 | 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 |
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
|
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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 | 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 |