E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Dermatitis in adults |
Dermatitis Atópica en Adultos |
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E.1.1.1 | Medical condition in easily understood language |
Atopic Eczema in adults |
Eccema atópico en adultos |
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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 | 19.1 |
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 evaluate the safety and efficacy of multiple doses of ABT-494 monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis |
Evaluar la seguridad y la eficacia de dosis repetidas de ABT-494 en monoterapia, en comparación con placebo, en el tratamiento de adultos con dermatitis atópica moderada a grave. |
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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 |
• Adult male or female, ≥ 18 and ≤ 75 years old at Screening. • Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to baseline. • Moderate to severe atopic dermatitis defined by an EASI ≥ 16, BSA ≥ 10% and an IGA score ≥ 3 at the Baseline visit. • Documented history (within 1 year prior to the screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks). • Twice daily use of an additive-free, bland emollient for at least 7 days prior to Baseline. |
- Hombres o mujeres adultos, ≥ 18 y ≤ 75 años de edad en la selección. - Dermatitis atópica, con diagnóstico confirmado por un dermatólogo (según los criterios de Hanifin y Rajka) e inicio de los síntomas al menos 1 año antes del momento basal. - Dermatitis atópica moderada a grave, definida por un EASI ≥ 16, SCA ≥ 10% y puntuación IGA ≥ 3 en la visita basal. - Antecedentes documentados (durante el año previo a la visita de selección) de respuesta insuficiente al tratamiento con corticosteroides tópicos (CST) o inhibidores de la calcineurina tópicos, o sujetos en los que los tratamientos tópicos están médicamente desaconsejados por cualquier otro motivo (p. ej., debido a efectos secundarios importantes o riesgos para la seguridad. - Uso de un emoliente suave sin aditivos, dos veces al día, durante al menos los 7 días previos a la visita basal. |
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E.4 | Principal exclusion criteria |
• Prior exposure to any systemic or topical JAK inhibitor (including but not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib). • Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit. • Prior exposure to dupilumab. • Prior exposure to any investigational systemic treatment within 30 days or 5 half-lives (whichever is longer) of the Baseline visit or is currently enrolled in another clinical study. |
- Exposición previa a cualquier inhibidor de JAK (por ejemplo, tofacitinib, baricitinib o filgotinib). - Tratamiento con corticosteroides tópicos (CST), inhibidores de la calcineurina tópicos (ICT), hidratantes de venta con receta o hidratantes que contengan aditivos como ceramida, ácido hialurónico, urea o filagrina, en los 10 días previos a la visita basal. - Exposición previa a dupilumab. - Exposición previa a cualquier tratamiento sistémico experimental en los 30 días previos o las 5 semividas previas (lo que suponga más tiempo) a la visita basal o participación actual en otro estudio clínico. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean percent (%) change from Baseline (Day 1) in EASI score at Week 16. |
Variación porcentual (%) media de la puntuación EASI entre la visita basal (día 1) y la semana 16. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Proportion of subjects achieving an EASI 75 response, defined as at least a 75% reduction in EASI score, at Week 16 relative to the Baseline (Day 1) • Proportion of subjects achieving an Investigator Global Assessment (IGA) of 0 or 1 at Week 16 • Percent change from Baseline to Weeks 2, 8 and 16 in pruritus numerical rating scale (NRS) • Percent change in EASI score from Baseline at Week 8 • Proportion of subjects achieving EASI 50/75/90 response at Weeks 8 and 16 • Proportion of subjects achieving SCORAD 50/75/90 response at Weeks 8 and 16 • Proportion of subjects with Dermatology Life Quality Index (DLQI) = "0" or "1" at Weeks 8 and 16 • Change from Baseline in DLQI at Weeks 8 and 16 |
- Proporción se sujetos que logran una respuesta EASI 75, definida como una reducción de al menos el 75% en la puntuación EASI entre la visita basal (día 1) y la semana 16. - Proporción de sujetos con una puntuación de 0 o 1 en la evaluación global por el investigador (IGA) en la semana 16. - Variación porcentual de la puntuación en la escala numérica (NRS) del prurito entre la visita basal y las semanas 2, 8 y 16. - Variación porcentual de la puntuación EASI entre la visita basal y la semana 8. - Proporción de sujetos que logran una respuesta EASI 50/75/90 en las semanas 8 y 16. - Proporción se sujetos que logran una respuesta SCORAD 50/75/90 en las semanas 8 y 16. - Proporción de sujetos con un índice de calidad de vida dermatológica (DLQI) de 0 o 1 en las semanas 8 y 16. - Variación del DLQI entre el momento basal y las semanas 8 y 16. - |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 8 and Week 16 |
Semana 8 y 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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 4 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
European Union |
Japan |
Puerto Rico |
United States |
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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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |