Clinical Trials Register

Summary
EudraCT Number:	2018-000349-38
Sponsor's Protocol Code Number:	I4V-MC-JAIP
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-01-18
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-000349-38

A.3

Full title of the trial

I4V-MC-JAIP
A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate to Severe Atopic Dermatitis

I4V-MC-JAIP
Estudio de fase 3, multicéntrico, aleatorizado, comparativo con placebo, con enmascaramiento doble y grupos paralelos, en el que se evalúa la farmacocinética, la eficacia y la seguridad de baricitinib en niños enfermos ambulatorios con dermatitis atópica moderada o grave

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study of Efficacy and Safety in Pediatric Patients with Atopic Dermatitis

Estudio de la eficacia y la seguridad en niños enfermos con dermatitis atópica

A.3.2

Name or abbreviated title of the trial where available

BREEZE-AD-PEDS

A.4.1

Sponsor's protocol code number

I4V-MC-JAIP

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/291/2018

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Lilly S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly Cork Ltd
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Island House, Eastgate Road, Eastgate Business Park
B.5.3.2	Town/ city	Little Island
B.5.3.3	Post code	.
B.5.3.4	Country	Ireland
B.5.6	E-mail	ensayosclinicos@lilly.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Olumiant
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ. Utrecht, the Netherlands
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Olumiant
D.3.2	Product code	LY3009104
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	baricitinib
D.3.9.2	Current sponsor code	LY3009104
D.3.9.3	Other descriptive name	BARICITINIB
D.3.9.4	EV Substance Code	SUB31583
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Olumiant
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ. Utrecht, the Netherlands
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Olumiant
D.3.2	Product code	LY3009104
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	baricitinib
D.3.9.2	Current sponsor code	LY3009104
D.3.9.3	Other descriptive name	BARICITINIB
D.3.9.4	EV Substance Code	SUB31583
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Olumiant
D.3.2	Product code	LY3009104
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	baricitinib
D.3.9.2	Current sponsor code	LY3009104
D.3.9.3	Other descriptive name	BARICITINIB
D.3.9.4	EV Substance Code	SUB31583
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Olumiant
D.3.2	Product code	LY3009104
D.3.4	Pharmaceutical form	Suspension for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	baricitinib
D.3.9.2	Current sponsor code	LY3009104
D.3.9.3	Other descriptive name	BARICITINIB
D.3.9.4	EV Substance Code	SUB31583
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Suspension for oral suspension
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

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] - 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

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is to demonstrate the superiority of each dose of
baricitinib to placebo in the treatment of patients with moderate to severe AD.
Primary Objective for PK lead-in Period is to assess whether baricitinib exposure in pediatric patients receiving baricitinib high dose once daily is comparable to the exposure in adults receiving baricitinib 4-mg once daily.

El objetivo principal del estudio es demostrar la superioridad de cada una de las dosis de baricitinib en comparación con el placebo en el tratamiento de pacientes con DA moderada o grave.
El objetivo principal para el período de preinclusión farmacocinética es evaluar si la exposición a baricitinib en niños enfermos que reciben la dosis alta de baricitinib una vez al día es comparable con la exposición en adultos que reciben la dosis de 4 mg de baricitinib una vez al día

E.2.2

Secondary objectives of the trial

•Compare the efficacy of baricitinib high, medium, or low dose to placebo as measured by improvement in AD symptoms
•Compare the efficacy of baricitinib high, medium, or low dose to placebo as measured by patient-reported outcomes and quality of life assessments
•Assess acceptability and palatability of baricitinib tablets and oral suspension
•Characterize the PK profile of baricitinib in pediatric patients
•Evaluate effect of baricitinib on cellular and humoral immune system
•Assess safety of baricitinib during longer-term treatment
•Assess growth and bone safety during longer-term treatment

• Comparar la eficacia de las dosis alta, media y baja de baricitinib con la del placebo en función de la mejoría de los síntomas de la DA.
• Comparar la eficacia de las dosis alta, media y baja de baricitinib con la del placebo en función de los resultados percibidos por el paciente y las evaluaciones de la calidad de vida.
• Evaluar la aceptabilidad y la palatabilidad de la suspensión y los comprimidos orales de baricitinib.
• Caracterizar el perfil farmacocinético de baricitinib en niños enfermos.
• Evaluar el efecto de baricitinib sobre el sistema inmunitario celular y humoral.
• Evaluar la seguridad de baricitinib durante el tratamiento a largo plazo.
• Evaluar el crecimiento y la seguridad ósea durante el tratamiento a largo plazo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old).
- Have a documented history by a physician and/or investigator of inadequate response to OR history of intolerance to topical corticosteroids (TCS) AND topical calcineurin inhibitors (TCNI).
- Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
- Agree to use emollients daily

- Diagnóstico de dermatitis atópica moderada o grave al menos desde hace 12 meses (para los pacientes de 6 años o más) o al menos desde hace 6 meses (para los pacientes de 2 a 6 años).
- Antecedentes documentados (por parte de un médico o del investigador) de respuesta insuficiente a corticoesteroides tópicos (CT) Y a inhibidores de la calcineurina de administración tópica (ICT), O antecedentes de intolerancia a estos tratamientos.
- Estar dispuesto a interrumpir ciertos tratamientos para el eccema (como los tratamientos tópicos y sistémicos durante el período de reposo farmacológico).
- Estar dispuesto a aplicarse emolientes todos los días.

E.4

Principal exclusion criteria

- Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
- A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
- Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
- Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
- Have been treated with the following therapies:
Monoclonal antibody for less than 5 half-lives prior to randomization.
Received prior treatment with any oral Janus kinase (JAK) inhibitor.
Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
- Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
- Have high blood pressure characterized by a repeated systolic blood pressure >95th percentile based on age, sex and height.
- Have had major surgery within the past eight weeks or are planning major surgery during the study.
- Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- Have a history of VTE or are considered at high risk of VTE as deemed by the investigator.
- Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster (shingles or chicken pox), tuberculosis.
- Have specific laboratory abnormalities.
- Have received certain treatments that are contraindicated.
- Pregnant or breastfeeding.

- Sufrir en la actualidad o haber sufrido otras enfermedades cutáneas concomitantes (por ejemplo, psoriasis o lupus eritematoso), o antecedentes de una enfermedad cutánea eritrodérmica, resistente al tratamiento o inestable, que requiera hospitalización o tratamiento intravenoso para las infecciones cutáneas con frecuencia.
- Antecedentes de eccema herpético en el transcurso de los 12 últimos meses o de 2 o más episodios de eccema herpético en el pasado.
- Presentar en la actualidad una infección cutánea que requiera tratamiento o recibir en la actualidad antibióticos sistémicos o tópicos.
- Presentar cualquier enfermedad grave para la que se prevea el uso de corticoesteroides sistémicos, que afecte la participación en el estudio de algún otro modo o requiera seguimiento activo y frecuente (por ejemplo, asma crónica inestable).
- Haber recibido los tratamientos siguientes:
anticuerpos monoclonales antes de la aleatorización (período inferior a 5 semividas del fármaco).
Haber recibido tratamiento previo con cualquier inhibidor oral de las janocinasas (JAK).
Haber recibido corticoesteroides por vía parenteral (mediante inyección intramuscular o intravenosa [i.v.]) en el transcurso de las 2 semanas anteriores a la inclusión en el estudio o de las 6 semanas anteriores a la fecha prevista de aleatorización, o que se prevea que vayan a requerir inyecciones parenterales de corticoesteroides durante el estudio
- Haber recibido corticoesteroides por vía intraarticular en el transcurso de las 2 semanas anteriores a la inclusión en el estudio o de las 6 semanas anteriores a la fecha prevista de aleatorización.
- Presentar hipertensión arterial (esto es, mediciones repetidas de tensión arterial sistólica >95 % en función de la edad, el sexo y la estatura).
- Haberse sometido a una intervención de cirugía mayor en el transcurso de las últimas 8 semanas o tener prevista una intervención de cirugía mayor durante el estudio.
- Haber experimentado alguna de las siguientes enfermedades en el transcurso de las 12 semanas anteriores a la selección:
episodio tromboembólico venoso (ETV), infarto de miocardio (IM), cardiopatía isquémica inestable, accidente cerebrovascular o insuficiencia cardiaca de clase III/IV de acuerdo con los criterios de la New York Heart Association.
- Antecedentes de ETV o que el investigador considere que el paciente presenta riesgo alto de ETV.
- Tener antecedentes o presentar enfermedades cardiovasculares, respiratorias, hepáticas (incluidas las crónicas), gastrointestinales, endocrinas, hematológicas, neurológicas, linfoproliferativas o neuropsiquiátricas, o cualquier otra enfermedad grave o inestable.
- Presentar o haber presentado recientemente una infección grave desde el punto de vista clínico (vírica, bacteriana, fúngica o parasitaria), incluidos el herpes zóster o la tuberculosis.
- Presentar determinadas alteraciones en las pruebas analíticas.
- Haber recibido ciertos tratamientos contraindicados.
- Pacientes embarazadas o en período de lactancia.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients achieving IGA of 0 or 1 at week 16
Comparability of baricitinib exposure as assessed by PK parameters such as AUC, Cmax (Period 2 patients only)

Porcentaje de pacientes que en la semana 16 alcancen una puntuación de 0 o 1 en la EGI.
Comparabilidad de la exposición a baricitinib de acuerdo con parámetros farmacocinéticos como el ABC o la Cmáx (solo pacientes en el período 2).

E.5.1.1

Timepoint(s) of evaluation of this end point

at week 16

En la semana 16

E.5.2

Secondary end point(s)

EASI 75 / 90 / CFB at week 16
SCORAD 75 at week 16
TCS use: mean amount used and number of days without TCS use (over first 16 weeks)
Itch NRS improvement of 4+ points at weeks 1,2, 4 and 16
Mean changes in AD symptoms based on clinician and patient assessment.
Mean changes in health outcomes and QoL Assessments (parent and family).
Pop PK assessment based on sparse sampling of patients in the double-blind portion of the trial (Period 3 only)
Acceptability/Palatability of oral tablet and suspension formulations of baricitinib (Period 2 only)
Changes in pre- and postvaccination IgG titers in patients eligible for TDaP and pneumococcal vaccines.
Mean changes in height, weight, growth velocity over the course of the study.
IGA of 0 or 1 at 1 and 2 years and EASI75 and SCORAD75 at 1 year

EASI 75 / 90 / variación respecto al período inicial en la semana 16.
SCORAD 75 en la semana 16.
Uso de CT: media de la cantidad aplicada y número de días en los que no se hayan utilizado CT (durante las primeras 16 semanas).
Mejoría de al menos 4 puntos en la EVN del picor en las semanas 1, 2, 4 y 16.
Media de las variaciones en los síntomas de la DA de acuerdo con la evaluación del médico y del paciente.
Media de las variaciones en los resultados de salud y las evaluaciones de la calidad de vida (padres y familia).
Evaluación de la farmacocinética poblacional con un muestreo limitado en pacientes que participen en la parte del estudio con enmascaramiento doble (solo el período 3).
Aceptabilidad/palatabilidad de la suspensión y los comprimidos orales de baricitinib (solo el período 2).
Variaciones en los títulos de IgG antes y después de la vacunación en los pacientes tributarios de la vacuna para el tétanos, la difteria y la tos ferina (TDT) y vacunas antineumocócicas.
Media de las variaciones en la estatura, el peso y la velocidad de crecimiento a lo largo del estudio.
Proporción de pacientes que al cabo de 1 y de 2 años alcancen una puntuación de 0 o 1 en la EGI y al cabo de 1 año, puntuaciones EASI75 y SCORAD75.

E.5.2.1

Timepoint(s) of evaluation of this end point

at week 16 and 1-2 years

En la semana 16 y al cabo de 1-2 años.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Brazil

Czech Republic

France

Germany

Greece

Hungary

Israel

Mexico

Poland

Russian Federation

Spain

Switzerland

Taiwan

Ukraine

United Kingdom

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 date of the last visit or last scheduled procedure shown for the last active patient in the study

Fecha de la última visita 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

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

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

465

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

130

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

335

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

238

F.4.2.2

In the whole clinical trial

465

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After the conclusion of the study, continued access to baricitinib will not be provided. Patients will be referred to their local treatment centers for AD therapy as clinically indicated.

Tras la finalización del estudio no se proporcionará acceso continuado a baricitinib. Se derivará a los pacientes a sus respectivos ambulatorios para que se les administre el tratamiento para la DA indicado clínicamente.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-02-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-24

P. End of Trial
P.	End of Trial Status	Ongoing

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