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 also known as Eczema |
Dermatitis Atópica tambien conocido como Eczema |
|
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 |
|
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 this long term extention trial is to estimate the effect of long term therapy with baricitinib on responders and partial responders at entry of JAHN. |
El objetivo primario es estimar el efecto del tratamiento con baricitinib a largo plazo desde el punto de vista de los pacientes que en el momento de la inclusión en el estudio JAHN hayan respondido total o parcialmente al tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of increasing or maintaining baricitinib dose on clinical measures and patient reported outcomes. To evaluate the effect of starting baricitinib on clinical measures and patient reported outcomes. To evaluate the effect of maintaining baricitinib dose on clinical measures. |
Evaluar el efecto de aumentar o mantener la dosis de baricitinib sobre los criterios de valoración clínicos y los resultados percibidos por el paciente. Evaluar el efecto de comenzar a administrar baricitinib sobre los criterios de valoración clínicos y los resultados percibidos por el paciente. Evaluar el efecto de mantener la dosis de baricitinib sobre los criterios de valoración clínicos |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Study JAHN will evaluate the effect of stopping or decreasing the dose of baricitinib in the context of a randomized treatment withdrawal and downtitration substudy starting at Week 52.
Objectives: To evaluate the change in clinical response after treatment withdrawal or down titration. To evaluate for patients retreated during substudy the ability to recapture efficacy based on clinical measures after experiencing a loss of treatment benefit. |
En el estudio JAHN se evaluará el efecto de la interrupción de la administración o de la reducción de la dosis de baricitinib en un subestudio de retirada y reducción de la dosis del tratamiento de forma aleatorizada que comenzará a partir de la semana 52. Objetivos: Evaluar la variación en la respuesta clínica tras la retirada o la reducción de la dosis del tratamiento. En los pacientes que vuelvan a recibir el tratamiento durante el subestudio, evaluar la capacidad de ser eficaz de nuevo tras una pérdida de beneficio terapéutico, de acuerdo con criterios de valoración clínicos. |
|
E.3 | Principal inclusion criteria |
- Have completed the final active treatment visit for an originator study (such as JAHL or JAHM) - 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. |
- Haber completado la visita final del tratamiento activo de un estudio anterior (como el JAHL o el JAHM). - 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. |
|
E.4 | Principal exclusion criteria |
- Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the patient if IP continues to be administered. - Had IP permanently discontinued at any time during a previous baricitinib study, except for patients who had IP discontinued during originating study due to rescue with an oral systemic AD therapy (e.g., corticosteroid, cyclosporine, methotrexate) - Had temporary IP interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the study. |
- Presentar enfermedades importantes sin controlar (cerebrocardiovasculares, respiratorias, hepáticas, renales, gastrointestinales, endocrinas, hematológicas o trastornos neuropsiquiátricos) o valores analíticos anómalos durante un estudio anterior de baricitinib que, en opinión del investigador, constituyan un riesgo inaceptable para el paciente en caso de que el producto en fase de investigación continúe administrándose. - Que la administración del producto en fase de investigación se haya interrumpido permanentemente durante un estudio anterior de baricitinib, salvo que se debiera a la administración de un tratamiento sistémico de rescate por vía oral para la dermatitis atópica (por ejemplo, corticoesteroides, ciclosporina, metotrexato). - Que la administración del producto en fase de investigación se haya interrumpido temporalmente en la visita final de un estudio anterior de baricitinib y que, en opinión del investigador, constituya un riesgo inaceptable para el paciente si participa en el estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with a response of IGA 0 or 1 |
Porcentaje de pacientes que presenten una respuesta de 0 o 1, de acuerdo con la EGI |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
16, 36 and 52 weeks after re-randomization of feeder trial |
16, 36 y 52 semanas después de la repetición de la aleatorización en el estudio anterior |
|
E.5.2 | Secondary end point(s) |
1. Proportion of patients with a response of IGA 0, 1, or 2 2. Proportion of patients achieving response of EASI75 from baseline of originating study 3. Proportion of patients with a 4-point improvement in Itch NRS from baseline of originating study 4. Proportion of patients with a response of IGA 0 or 1 |
1. Porcentaje de pacientes que presenten una respuesta de 0, 1 o 2, de acuerdo con la EGI. 2. Porcentaje de pacientes que alcancen una respuesta de 75 en el índice EASI respecto al período basal del estudio anterior. 3. Porcentaje de pacientes que presenten una mejoría de 4 puntos en la EVN del picor respecto al período basal del estudio anterior. 4. Porcentaje de pacientes que presenten una respuesta de 0 o 1, de acuerdo con la EGI. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 and 2: assessed at Weeks 16, 36, and 52 3: assessed at week 16 4: assessed at Weeks 16, 36, and 52 (nonresponders) |
1 y 2: evaluados en las semanas 16, 36 y 52. 3: evaluado en la semana 16. 4: evaluados en las semanas 16, 36 y 52 (pacientes que no respondan al tratamiento). |
|
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 | 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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 64 |
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 |
Canada |
Czech Republic |
France |
Germany |
Hungary |
India |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Poland |
Russian Federation |
Slovenia |
Spain |
Switzerland |
Taiwan |
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
|
The End of the trial is definde as the date of the last visit (LVLS) or last scheduled procedure shown in the Schedule of Activities for the last patient as outlined in the protocol. |
El final del ensayo es la fecha de la última visita o del último procedimiento programado para el último paciente del estudio, según se detalla en el calendario de actividades del protocolo |
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |