E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate and Severe Atopic Dermatitis |
Demartitis atópica moderada o grave |
|
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 | 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 for the treatment of adolescent and adult subjects with moderate to severe Atopic Dermatitis who are candidates for systemic therapy. |
Evaluar la eficacia y la seguridad de upadacitinib para el tratamiento de pacientes adolescentes y adultos con dermatitis atópica moderada o grave que sean candidatos a recibir tratamiento sistémico |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy and safety of 15 mg and 30mg upadacitinib for the treatment of adolescent and adult subjects with moderate to severe Atopic Dermatitis through up to 136 weeks in subjects who have completed week 16. |
Evaluar la eficacia y seguridad de upadacitinib de 15 mg y 30 mg para el tratamiento de adolescentes y adultos con dermatitis atópica moderada o grave durante hasta 136 semanas en pacientes que completaron la semana 16 |
|
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 |
Hombres o mujeres de 12-75 años de edad • Dermatitis atópica activa moderada o grave definida por EASI, IGA, BSA y prurito Candidato para terapia sistémica o recientemente requirió terapia sistémica para dermatitis atópica • Candidato para terapia sistémica o ha requerido de manera reciente terapia sistémica para dermatitis atópica |
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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 de JAK • Incapaz o no dispuesto a suspender los tratamientos actuales con Dermatitis atópica antes del estudio • Cumplimiento de los criterios de medicación prohibida durante el estudio • Otras enfermedades activas de la piel o infecciones de la piel que requieren tratamiento sistémico o que podrían interferir con la adecuada evaluación de las lesiones de dermatitis atópica • Paciente mujer que está embarazada, en lactancia o que está considerando quedarse embarazada durante el estudio |
|
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 sujetos que lograron una puntuación IGA validada de la Dermatitis atópica (vIGA-AD) de 0 o 1 con al menos dos grados de reducción desde el inicio en la semana 16; • Proporción de sujetos que lograron una mejora desde el inicio del estudio de al menos el 75% en el Índice de gravedad del área del eccema (EASI 75) en 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) |
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 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; • Proportion of subjects achieving an improvement (reduction) in worst pruritus NRS ≥ 4 from Baseline at Week 1; • Proportion of subjects achieving EASI 50 at Week 1. |
Los objetivos secundarios ajustados por multiplicidad para fines reglamentarios UE / EMA son • Proporción de sujetos que lograron en la semana 16 una mejoría (reducción) en la escala de valoración numérica (EVN) del peor prurito ≥ 4 desde el inicio; • Proporción de sujetos que alcanzaron EASI 90 en la semana 16; • Cambio porcentual en la semana 16 desde la visita de inicio de la EVN del peor prurito; • Cambio porcentual en la evaluación del EASI desde la visita de inicio en la semana 16; • Proporción de sujetos que lograron en la semana 1 una mejoría (reducción) en la EVN del peor prurito ≥ 4 desde el la visita de inicio; • Proporción de sujetos que alcanzaron EASI 50 en la semana 1. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 Week 16 Week 16 Week 16 Week 1 Week 1 |
Semana 16 Semana 16 Semana 16 Semana 16 Semana 1 Semana 1 |
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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 | 60 |
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 |
New Zealand |
Singapore |
Switzerland |
Taiwan |
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 |