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 |
Dermatitis atópica |
|
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 | 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 |
• To compare the efficacy of LY3375880 to placebo as measured by IGA at Week 16 in the treatment of subjects with moderate-to-severe AD |
Comparar la eficacia de LY3375880 con la del placebo en el tratamiento de pacientes con DA de moderada a grave, de acuerdo con la EGI en la semana 16. |
|
E.2.2 | Secondary objectives of the trial |
• To compare the efficacy of LY3375880 to placebo as measured by improvement in signs and symptoms at Week 16 and 52 in the treatment of subjects with moderate-to-severe AD
• To characterize the PK of LY3375880 in subjects with moderate-to-severe AD |
• Comparar la eficacia de LY3375880 con la del placebo en el tratamiento de pacientes con DA de moderada a grave, de acuerdo con la EGI en la semana 16.
• Caracterizar la FC de LY3375880 en pacientes con DA de moderada a grave. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
--At least 18 years of age at the time of informed consent --Diagnosis of AD >= 12 months according to AAD criteria (Eichenfeld, 2014) --Moderate to severe AD at screening and randomization --Inadequate response to topical medications within 6 months of screening (or history of intolerance) |
-- Al menos 18 años de edad en el momento de la firma del consentimiento informado. -- Diagnóstico de DA al menos desde hace 12 meses, de acuerdo con los criterios de la AAD (Eichenfeld, 2014). -- DA de moderada a grave durante la selección y la aleatorización. -- Respuesta insuficiente a medicamentos tópicos en el transcurso de los 6 meses anteriores a la selección (o antecedentes de intolerancia a estos medicamentos). |
|
E.4 | Principal exclusion criteria |
--Have received any prior treatment with dupilumab or any agent directly targeting Il-33 or IL-13 --Concurrent treatment with topical or systemic treatments for AD |
-- Haber recibido anteriormente cualquier tratamiento con dupilumab o con otro medicamento que actúe directamente sobre la IL-33 o la IL-13. -- Administración concomitante de tratamientos tópicos o sistémicos para la DA. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving IGA of 0 or 1 with a ≥2 point improvement |
Porcentaje de pacientes que alcancen una puntuación de 0 o 1 en la EGI, con una mejoría ≥2 puntos. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Proportion of subjects achieving at Week 16 o EASI-50 o EASI-75 o EASI-90 o SCORAD-75 o SCORAD-90 o IGA of 0
Mean change from baseline to Week 16 in o EASI o SCORAD
Proportion of subjects achieving IGA of 0 or 1 at Week 52
Serum PK Data |
Porcentaje de pacientes que en la semana 16 alcancen: o una respuesta EASI-50 o una respuesta EASI-75 o una respuesta EASI-90 o una respuesta SCORAD-75 o una respuesta SCORAD-90 o una puntuación de 0 en la EGI Media de la variación entre el período inicial y la semana 16 en: o el índice EASI o el índice SCORAD Porcentaje de pacientes que en la semana 52 alcancen una puntuación de 0 o 1 en la EGI. Datos relativos a la FC sérica. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 and Week 52 |
Semana 16 y semana 52 |
|
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 | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 |
Austria |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Italy |
Japan |
Spain |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
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
|
The date of the last visit or last scheduled procedure shown for the last active patient in the study |
Fecha de la última vista o del último procedimiento programado para el último paciente activo del estudio |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial days | 7 |