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 |
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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 evaluate the efficacy of tralokinumab compared with placebo in treating moderate-to-severe Atopic dermatitis. |
Evaluar la eficacia de tralokinumab en el tratamiento de la Dermatitis atópica moderada a grave |
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E.2.2 | Secondary objectives of the trial |
During the initial treatment period: - To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo.
During the maintenance treatment period: - To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at 16 weeks. |
Durante el periodo de tratamiento inicial: - Evaluar la eficacia de tralokinumab en la reducción de la gravedad y extensión de la DA, el prurito y la mejora de la calidad de vida relacionada con la salud, en comparación con placebo.
Durante el periodo de tratamiento de mantenimiento: - Evaluar el efecto del mantenimiento con la administración continuada de tralokinumab hasta un máximo de 52 semanas, en comparación con placebo, para los pacientes que obtengan respuesta clínica en la semana 16. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age 18 and above • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. • Diagnosis of AD for ≥1 year. • Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable. • AD involvement of ≥10% body surface area at screening and baseline. • An EASI score of ≥12 at screening and 16 at baseline. • An IGA score of ≥3 at screening and at baseline. • A Worst Daily Pruritus numeric rating scale (NRS) average score of ≥4 during the week prior to baseline. • Stable dose of emollient twice daily for at least 14 days before randomisation. |
• Mayores de 18 años. • Diagnóstico de DA definido por los criterios de Hanifin y Rajka (1980) para la DA. • Diagnóstico de DA ≥1 año. • Pacientes con antecedentes recientes de respuesta inadecuada al tratamiento con medicamentos tópicos o para quienes los tratamientos tópicos resulten desaconsejables por otras razones médicas. • DA que afecte al ≥10 % de la superficie corporal en la selección y en el inicio. • Puntuación EASI de ≥12 en la selección y 16 en el inicio. • Puntuación EGI(IGA) de ≥3 en la selección y en el inicio. • Puntuación media de la escala numérica de calificación (ENC) del peor prurito diario ≥4 durante la semana previa al inicio. • Dosis estable de emoliente dos veces al día durante al menos 14 días antes de la aleatorización. |
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E.4 | Principal exclusion criteria |
• Active dermatologic conditions that may confound the diagnosis of AD. • Use of tanning beds or phototherapy within 6 weeks prior to randomisation. • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation. • Treatment with TCS and/or TCI within 2 weeks prior to randomisation. • Active skin infection within 1 week prior to randomisation. • Clinically significant infection within 4 weeks prior to randomisation. • A helminth parasitic infection within 6 months prior to the date informed consent is obtained. • Tuberculosis requiring treatment within the 12 months prior to screening. • Known primary immunodeficiency disorder. |
• Trastornos dermatológicos activos que puedan confundir el diagnóstico de la DA. • Uso de cabinas bronceadoras o fototerapia en las 6 semanas previas a la aleatorización. • Tratamiento con fármacos inmunosupresores/inmunomoduladores sistémicos o corticoides sistémicos en las 4 semanas previas a la aleatorización. • Tratamiento con corticoides tópicos o inhibidores de la calcineurina tópicos en las 2 semanas previas a la aleatorización. • Infección cutánea activa en la semana previa a la aleatorización. • Infección clínicamente significativa en las 4 semanas previas a la aleatorización. • Infección parasitaria por helmintos en los 6 meses previos a la fecha de obtención del consentimiento informado. • Tuberculosis que requiera tratamiento en los 12 meses previos a la selección. • Inmunodeficiencia primaria conocida. |
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E.5 End points |
E.5.1 | Primary end point(s) |
For the initial treatment period: - IGA score of 0 (clear) or 1 (almost clear) at Week 16 - EASI75 at Week 16 |
Para el periodo de tratamiento inicial: - Puntuación EGI(IGA) de 0 (ausente) o 1 (casi ausente) en la semana 16. - EASI75 en la semana 16. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Bi-weekly throughout study. |
Cada 2 semanas durante todo el estudio |
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E.5.2 | Secondary end point(s) |
For the initial treatment period: Severity and extent of AD: Change in SCORAD from baseline to Week 16 Itch: Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 from baseline to Week 16. Quality of life: Change in DLQI score from baseline to Week 16
For the maintenance treatment period: IGA of 0/1 at Week 52 among subjects with IGA of 0/1 at Week 16 after initial randomisation to tralokinumab EASI75 at Week 52 among subjects with EASI75 at Week 16 after initial randomisation to tralokinumab |
Para el período de tratamiento inicial: - Gravedad y extensión de la DA: cambio en SCORAD desde el inicio hasta la semana 16. - Prurito: disminución de la ENC del peor prurito diario (promedio semanal) de al menos 4 desde el inicio hasta la semana 16. - Calidad de vida: cambio en la puntuación DLQI desde el inicio hasta la semana 16.
Para el período de tratamiento de mantenimiento: - EGI(IGA) de 0/1 en la semana 52 entre los pacientes con EGI(IGA) de 0/1 en la semana 16 tras la aleatorización inicial a tralokinumab. - EASI75 en la semana 52 entre los pacientes con EASI75 en la semana 16 tras la aleatorización inicial a tralokinumab. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Bi-weekly throughout study for assessment conducted by the HCP. For Puritus the assessment is done on a daily basis using an eDiary. For DLQI completed by the subject every 2, 4 or 8 weeks. |
Cada 2 semanas durante el estudio para la evaluación realizada por el investigador. Para el prurito la evaluación se realiza diariamente utilizando un diario/agenda electrónico/a. Para el DLQI completado por el paciente, cada 2, 4 u 8 semanas. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 5 |
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 | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
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 |
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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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last visit of the last subject undergoing the trial |
Última visita 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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |