E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic dermatitis |
Dermatitis atópica |
|
E.1.1.1 | Medical condition in easily understood language |
Atopic dermatitis / Eczema |
Dermatitis atópica/ Eccema |
|
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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
|
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 |
The primary objective of the study is to assess the ability of different dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with dupilumab monotherapy compared to placebo. |
El objetivo principal del estudio es evaluar la capacidad de diferentes regímenes de dosis de dupilumab, administrado en monoterapia, para mantener la respuesta al tratamiento alcanzada tras 16 semanas de tratamiento inicial con dupilumab en monoterapia, en comparación con placebo. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to assess the safety of different dupilumab dose regimens administered as monotherapy over a period of 36 weeks. |
El objetivo secundario del estudio es evaluar la seguridad de diferentes regímenes de dupilumab, administrado en monoterapia, a lo largo de un periodo de 36 semanas. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A patient must meet the following criteria to be eligible for inclusion in the study: 1. Must have completed the treatment phase in 1 of the two 16-week initial treatment studies (R668-AD-1334 or R668-AD-1416). 2. Must have achieved at least 1 of the following 2 treatment success criteria: IGA = 0 or 1 (clear or almost clear) at week 16 OR EASI-75 (at least 75% reduction in EASI score from baseline to week 16) 3. Must be willing and able to comply with clinic visits and study-related procedures 4. Must provide signed informed consent 5. Must be able to understand and complete study-related questionnaires |
Para que un paciente sea elegible a la inclusión en el estudio deberá cumplir los siguientes criterios: 1. Haber completado la fase de tratamiento en uno de los dos estudios iniciales de tratamiento de 16 semanas (R668-AD-1334 o R668-AD-1416). 2. Haber alcanzado como mínimo uno de los dos criterios de éxito del tratamiento siguientes: IGA = 0 o 1 (ausente o casi ausente) en la semana 16 O BIEN EASI-75 (reducción de la puntuación del EASI de al menos el 75% entre el momento basal y la semana 16) 3. Estar dispuesto a cumplir todas las visitas al centro y procedimientos del estudio, y ser capaz de hacerlo 4. Dar su consentimiento informado firmado 5. Ser capaz de comprender y cumplimentar los cuestionarios del estudio. |
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E.4 | Principal exclusion criteria |
A patient who meets any of the following criteria will be excluded from the study: 1. Receipt of rescue medication for AD in the initial treatment study 2. Any conditions that require permanent discontinuation of study treatment in either initial treatment study 3. Planned or anticipated major surgical procedure during the patient?s participation in this study 4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during this study
Birth control exclusion criterion # 5is listed in protocol section 4.2.2 |
Se excluirá del estudio a todo paciente que cumpla cualquiera de los siguientes criterios: 1. Uso de medicación de rescate para la DA en el estudio inicial tratamiento 2. Cualquier proceso que requiera la suspensión permanente del tratamiento del estudio en el estudio inicial de tratamiento 3. Planificación o previsión de una intervención de cirugía mayor durante la participación del paciente en este estudio 4. Mujeres embarazadas o en periodo de lactancia natural, o mujeres que tengan previsto quedarse embarazadas o dar el pecho durante este estudio 5. Mujeres que no deseen utilizar un método anticonceptivo adecuado, si son potencialmente fértiles y sexualmente activas.
Véase sección 4.2.2 del protocolo para mayor información sobre metodos anticonceptivos. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with IGA scores of 0 or 1 (clear or almost clear) at week 36
For the European Union (EU), EU reference market countries, and Japan only, the co-primary efficacy endpoint is: * EASI-75: Proportion of patients with EASI-75 (?75% improvement) at week 36 compared to the baseline EASI in the initial treatment study (R668-AD-1334 or R668-AD-1416) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint will be determined at week 36. |
|
E.5.2 | Secondary end point(s) |
Key secondary endpoint:
* Percent of patients whose Pruritus NRS increased by 3 or more points from baseline to week 36 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary endpoints will be determined from baseline to week 36. |
|
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 | 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 | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 132 |
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 |
Canada |
European Union |
Hong Kong |
Japan |
Korea, Republic of |
Singapore |
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
|
Last patient last visit in follow up phase (week 48) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |