E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Dermatitis |
Dermatitis Atópica |
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E.1.1.1 | Medical condition in easily understood language |
Atopic Dermatitis also known as Eczema |
Dermatitis Atópica también conocida como Eccema |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 test the hypothesis that baricitinib 4 mg QD + Topical Corticosteroids or baricitinib 2 mg QD + Topical Corticosteroids is superior to placebo + Topical Corticosteroids in the treatment of patients with moderate to severe AD. |
Evaluar la hipótesis de que baricitinib 4 mg 1 v/d + corticoesteroides tópicos o baricitinib 2 mg 1 v/d + corticoesteroides tópicos son superiores al placebo + corticoesteroides tópicos en el tratamiento de pacientes con DA de moderada a grave. |
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E.2.2 | Secondary objectives of the trial |
-To compare the efficacy of baricitinib 2 mg QD + Topical Corticosteroids or baricitinib 4 mg QD + Topical Corticosteroids to placebo + Topical Corticosteroids in AD during the 16 week double blind placebo controlled treatment period as measured by improvement in signs and symptoms of AD. -To compare the efficacy of baricitinib 2 mg QD + Topical Corticosteroids or baricitinib 4 mg QD + Topical Corticosteroids to placebo + Topical Corticosteroids in AD during the 16 week double blind placebo controlled treatment period as assessed by patient reported outcome measures. |
-Comparar la eficacia de baricitinib 2 mg 1 v/d + corticoesteroides tópicos o de baricitinib 4 mg 1 v/d + corticoesteroides tópicos con la del placebo + corticoesteroides tópicos en la DA durante el período de tratamiento con enmascaramiento doble y comparativo con placebo de 16 semanas de duración, de acuerdo con la mejoría de los signos y los síntomas de la DA. -Comparar la eficacia de baricitinib 2 mg 1 v/d + corticoesteroides tópicos o de baricitinib 4 mg 1 v/d + corticoesteroides tópicos con la del placebo + corticoesteroides tópicos en la DA durante el período de tratamiento con enmascaramiento doble y comparativo con placebo de 16 semanas de duración, de acuerdo con los resultados percibidos por el paciente. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-At least 18 years of age. -Have a diagnosis of AD at least 12 months prior to screening, as defined by the American Academy of Dermatology -Have moderate to severe AD, including all of the following: a. Eczema Area and Severity Index (EASI) score ≥16 b. IGA score of ≥3 c. ≥10% of BSA involvement -Have a documented history by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening, or history of intolerance to topical therapy. -Are male or nonpregnant, nonbreastfeeding female patients. Male patients, and female patients of childbearing potential, must agree to use a reliable method of birth control during the study and for at least 4 weeks following the last dose of investigational product. |
-Tener al menos 18 años. -Diagnóstico de DA al menos 12 meses antes de la selección, de acuerdo con los criterios de la American Academy of Dermatology -DA de moderada a grave, de acuerdo con todos los criterios siguientes: a. Puntuación ≥ 16 en el índice relativo a la intensidad y el área del eccema (del inglés, EASI) b. Puntuación ≥ 3 en la evaluación global por parte del investigador (EGI) c. ≥ 10 % de afectación de la superficie corporal -Antecedentes documentados (por parte de un médico o del investigador) de respuesta insuficiente a los medicamentos tópicos disponibles en el transcurso de los 6 meses anteriores a la selección, o antecedentes de intolerancia al tratamiento tópico. -Varones o mujeres que no estén embarazadas ni en período de lactancia. Los varones y las mujeres fértiles deben estar de acuerdo en utilizar un método anticonceptivo fiable durante el estudio y al menos durante las 4 semanas posteriores a la última dosis del producto en fase de investigación. |
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E.4 | Principal exclusion criteria |
-Have other concomitant skin conditions that would interfere with evaluations of the effect of study medication -Have had an important side effect to Topical Corticosteroids (e.g., intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects), as assessed by the investigator or treating physician that would prevent further use. -Are currently experiencing or have a history of erythrodermic,refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections that may interfere with participation in the study. -Skin infection that requires treatment with topical or systemic antibiotics. -Serious concomitant illness -Are immunocompromised and at an unacceptable risk for participating in the study. -Have a clinically serious viral, bacterial, fungal, or parasitic infection -Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study. -Have evidence of active TB or latent TB -Have evidence of HBV, HCV or HIV infection |
-Presentar simultáneamente otras enfermedades cutáneas que pudieran interferir en las evaluaciones del efecto del fármaco en estudio. -Haber sufrido, de acuerdo con el investigador o el médico responsable, un efecto secundario importante con los corticoesteroides tópicos (por ejemplo, intolerancia al tratamiento, reacciones de hipersensibilidad, atrofia cutánea importante y efectos generalizados) que impediría continuar administrándolos. -Sufrir en la actualidad o haber sufrido una enfermedad cutánea eritrodérmica, resistente al tratamiento o inestable que requiera hospitalizaciones frecuentes o tratamiento intravenoso para las infecciones cutáneas, lo que puede interferir en la participación en el estudio. -Infección cutánea que requiera tratamiento con antibióticos sistémicos o tópicos. -Enfermedad concomitante grave. -Que la participación en el estudio constituya un riesgo inaceptable para el paciente por presentar inmunodepresión. -Presentar una infección grave desde un punto de vista clínico (vírica, bacteriana, fúngica o parasitaria). -Haber recibido una vacuna elaborada con microbios vivos en el transcurso de las 12 semanas anteriores a la fecha prevista de aleatorización o que se prevea que se vaya a recibir/necesitar una vacuna elaborada con microbios vivos durante el transcurso del estudio. -Presentar signos de TB activa o latente. -Presentar signos de VHC, VHB o infección por el VIH. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving IGA of 0 or 1 with a ≥2 point improvement |
Porcentaje de pacientes que presenten una puntuación de 0 o 1 en la EGI, con una mejoría de ≥ 2 puntos. |
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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) |
1. Proportion of patients achieving EASI75 2. Proportion of patients achieving EASI90 3. Percent change from baseline in EASI score 4. Proportion of patients achieving SCORAD75 5.Mean change from baseline in the score of Item 2 of the ADSS 6.Mean change from baseline in Skin Pain NRS 7.Proportions of patients achieving a 4 point improvement in Itch NRS |
1. Porcentaje de pacientes que alcancen una respuesta EASI 75. 2. Porcentaje de pacientes que alcancen una respuesta EASI 90. 3. Variación porcentual respecto a la puntuación inicial en el EASI. 4. Porcentaje de pacientes que alcancen una puntuación SCORAD75. 5. Media de la variación respecto al período inicial en la puntuación del ítem 2 de la escala ADSS. 6. Media de la variación respecto al período inicial en la EVN del dolor cutáneo. 7. Porcentaje de pacientes que alcancen una mejoría de 4 puntos en la EVN 3 del picor. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoint 1 to 6 only at week 16 Endpoint 7 at week 1, week 2, week 4 and week 16 |
Criterios de valoración 1-6: solo en la semana 16. Criterio de valoración 7: semana 1, semana 2, semana 4 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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 |
Argentina |
Australia |
Austria |
Germany |
Italy |
Japan |
Korea, Republic of |
Poland |
Spain |
Taiwan |
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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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LVLS: End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient. |
UVUP: la finalización del estudio es la fecha de la última visita o el último procedimiento programado mostrado en el calendario de actividades del último paciente. |
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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 | 11 |
E.8.9.1 | In the Member State concerned days | 4 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 4 |