Clinical Trials Register

Summary
EudraCT Number:	2017-004574-34
Sponsor's Protocol Code Number:	I4V-MC-JAIN
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:	2018-04-27
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

2017-004574-34

A.3

Full title of the trial

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination with Topical Corticosteroids in Adult Patients with Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

Estudio de fase 3, multicéntrico, aleatorizado, doble ciego y comparado con placebo, para evaluar la seguridad y la eficacia de baricitinib en combinación con corticosteroides tópicos en pacientes adultos con dermatitis atópica de moderada a grave que no hayan respondido, presenten intolerancia o contraindicación al tratamiento con ciclosporina

A.3.1

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

A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine A or for Those Who Cannot Take Oral Cyclosporine A Because it is Not Medically Advisable

Estudio a largo plazo de baricitinib (LY3009104) con corticosteroides tópicos en adultos con dermatitis atópica moderada o grave no controlada con ciclosporina A o en aquellos que no pueden tomar este medicamento por vía oral por recomendación médica

A.3.2

Name or abbreviated title of the trial where available

BREEZE-AD4

A.4.1

Sponsor's protocol code number

I4V-MC-JAIN

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

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	Lilly S.A.
B.5.2	Functional name of contact point	Paula Anabella Fotti
B.5.3	Address:
B.5.3.1	Street Address	Av de la Industria 30
B.5.3.2	Town/ city	Alcobendas/ Madrid
B.5.3.3	Post code	28108
B.5.3.4	Country	Spain
B.5.4	Telephone number	34916635039
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	Film-coated 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.3.9.3	Other descriptive name	baricitinib
D.3.9.4	EV Substance Code	SUB180983
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	Film-coated 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.3.9.3	Other descriptive name	baricitinib
D.3.9.4	EV Substance Code	SUB180983
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	Film-coated 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.3.9.3	Other descriptive name	baricitinib
D.3.9.4	EV Substance Code	SUB180983
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.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	Film-coated 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	Film-coated 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	Film-coated tablet
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 also known as Eczema

Dermatitis atópica (también denominada "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	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

To test the hypothesis that baricitinib 4 mg + topical corticosteroids (TCS) or baricitinib 2 mg + TCS is superior to placebo + TCS in the treatment of moderate to severe atopic dermatitis

Evaluar la hipótesis de que baricitinib 4 mg + corticosteroides tópicos (CT) o baricitinib 2 mg + CT es superior al placebo + CT en el tratamiento de la dermatitis atópica moderada o grave.

E.2.2

Secondary objectives of the trial

• To test the hypothesis that baricitinib 1 mg + topical corticosteroids (TCS) is superior to placebo + TCS in the treatment of patients with moderate to severe atopic dermatitis.
• To compare the efficacy of baricitinib 4 mg + TCS, baricitinib 2 mg + TCS, or baricitinib 1 mg + TCS to placebo + TCS in atopic dermatitis during the double blind placebo controlled treatment period as measured by improvement of signs and symptoms of atopic dermatitis.
• To compare the efficacy of baricitinib 4 mg + TCS, baricitinib 2 mg + TCS, or baricitinib 1 mg + TCS to placebo + TCS in atopic dermatitis during the double blind placebo controlled treatment period as assessed by patient reported outcome measures.

• Evaluar la hipótesis de que baricitinib 1 mg + corticosteroides tópicos (CT) es superior al placebo + CT en el tratamiento de pacientes con dermatitis atópica moderada o grave.
• Comparar la eficacia de baricitinib 4 mg + CT, baricitinib 2 mg + CT o baricitinib 1 mg + CT con la del placebo + CT en la dermatitis atópica durante el período de tratamiento con enmascaramiento doble y comparativo con placebo de acuerdo con la mejoría de los signos y los síntomas de la dermatitis atópica.
• Comparar la eficacia de baricitinib 4 mg + CT, baricitinib 2 mg + CT o baricitinib 1 mg + CT con la del placebo + CT en la dermatitis atópica durante el período de tratamiento con enmascaramiento doble y comparativo con placebo de acuerdo con los resultados percibidos por el paciente

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

Randomized DownTitration Substudy at week 52
During the long term extension (Period 3), eligible patients will participate in a downtitration substudy. The objective of the substudy is to evaluate the possibility of maintaining efficacy with a lower dose of baricitinib in patients with response (IGA 0 or 1) or partial response (IGA 2) to baricitinib 2-mg QD or 4-mg QD in combination with topical corticosteroids.

Subestudio de disminución gradual y aleatorizada de la dosis en la semana 52. Durante la prolongación a largo plazo (período 3), los pacientes idóneos
participarán en un subestudio de disminución gradual de la dosis. El objetivo del subestudio es evaluar la posibilidad de mantener la eficacia con una dosis inferior de baricitinib en pacientes que presenten respuesta (puntuación de 0 o 1 de acuerdo con la EGI) o respuesta parcial (puntuación de 2 de acuerdo con la EGI) al tratamiento con baricitinib 2 mg o 4 mg una vez al día, en combinación con corticosteroides tópicos.

E.3

Principal inclusion criteria

• Have been diagnosed with moderate to severe Atopic Eczema (Atopic Dermatitis) for at least 12 months.
• Have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening.
• Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period and throughout the study).
• Agree to use emollients daily.
• Have a medical contraindication to cyclosporine A, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine A in the past.

• Diagnóstico de eccema atópico (dermatitis atópica) moderado o grave al menos desde hace 12 meses.
• Haber presentado respuesta insuficiente o intolerancia a los tratamientos tópicos existentes (de aplicación cutánea) en el transcurso de los 6 meses anteriores a la selección.
• Estar dispuesto a interrumpir ciertos tratamientos para el eccema (como los tratamientos tópicos y sistémicos, tanto durante el período de reposo farmacológico como durante el estudio).
• Estar dispuesto a usar emolientes todos los días.
• Presentar una contraindicación médica a la administración de ciclosporina A, o haber mostrado anteriormente intolerancia, toxicidad inaceptable o respuesta insuficiente a la ciclosporina A.

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 episodes of eczema herpeticum in the past.
• Participants who are currently experiencing a skin infection that requires treatment, or are 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 >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
• 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 recurrent (≥ 2) 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, 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 (por ejemplo, psoriasis o lupus eritematoso), o antecedentes de una enfermedad cutánea eritrodérmica, resistente al tratamiento o inestable que requiera la 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 anteriores de eccema herpético.
• 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 corticosteroides sistémicos, que afecte la participación en el estudio 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).
-Pacientes que hayan recibido corticosteroides, administrados por vía parenteral (mediante inyección intramuscular o intravenosa [IV]), en el transcurso de las 2 semanas previas a la inclusión en el estudio o de las 6 semanas previas a la fecha prevista de aleatorización, o que se prevea
que vayan a requerir inyecciones parenterales de corticosteroids durante el estudio.
-Haber ecibido corticosteroides por vía intrarticular en el transcurso de las 2 semanas previas a la inclusión en el estudio o de las 6 semanas
previas a la fecha prevista de aleatorización.
• Presentar hipertensión arterial (tensión arterial sistólica > 160 milímetros de mercurio [mm Hg] o tensión arterial diastólica > 100 mm Hg de forma repetida).
• 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 recurrentes (≥ 2) o riesgo alto de ETV según el criterio del investigador.
• Antecedentes o presencia de enfermedades cardiovasculares, respiratorias, hepáticas, gastrointestinales, endocrinas, hematológicas,
neurológicas, linfoproliferativas, neuropsiquiátricas, o hepatopatías crónicas o cualquier otra enfermedad grave o inestable.
• Presentar o haber presentado recientemente una infección grave desde un punto de vista clínico (vírica, bacteriana, fúngica o parasitaria),
incluidos el herpes zóster o la tuberculosis.
• Presentar determinadas alteraciones 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 Investigator’s Global Assessment (IGA) of 0 or 1 with a ≥ 2 point improvement

Porcentaje de pacientes que alcancen una puntuación de 0 o 1 en la evaluación global del investigador (EGI), con una mejoría de ≥ 2 puntos.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

Semana 16

E.5.2

Secondary end point(s)

1,
• Proportion of patients achieving Investigator’s Global Assessment (IGA) of 0 or 1 with a ≥ 2 point improvement
• Proportion of patients achieving EASI75
• Proportion of patients achieving EASI 90
• Mean change from baseline in EASI score
• Proportion of patients achieving SCORAD75
• Mean change from baseline in Skin Pain NRS

2;
• Proportion of patients achieving a 4-point improvement in Itch NRS
3;
• Mean change from baseline in the score of Item 2 of the ADSS
4;
• Proportion of patients achieving IGA of 0 or 1 with a ≥2-point improvement from baseline
• Proportion of patients achieving EASI75

1;
• Porcentaje de pacientes que alcancen una puntuación de 0 o 1 en la
evaluación global del investigador (EGI), con una mejoría de ≥ 2 puntos.
• Porcentaje de pacientes que alcancen una respuesta EASI 75.
• Porcentaje de pacientes que alcancen una respuesta EASI 90.
• Media de la variación en la puntuación EASI respecto al período basal.
• Porcentaje de pacientes que alcancen una respuesta SCORAD75.
• Media de la variación respecto al período basal en la EVN del dolor
cutáneo.
2;
• Porcentaje de pacientes que alcancen una mejoría de 4 puntos en la EVN del picor;
3
• Media de la variación respecto al período basal en la puntuación del ítem 2 de la escala ADSS
4;
• Porcentaje de pacientes que presenten una puntuación de 0 o 1 en la EGI, con una mejoría de ≥ 2 puntos respecto al período basal.
• Porcentaje de pacientes que alcancen una respuesta EASI 75.

E.5.2.1

Timepoint(s) of evaluation of this end point

1; assessed at week 16
2; assessed at 16, 4, 2, and 1 weeks
3; assessed at 16 weeks and 1 week.
4; assessed at 52 weeks

1; se evalúa en la semana 16.
2; se evalúa en las semanas 16, 4, 2 y 1.
3; se evalúa en las semanas 16 y 1.
4; se evalúa en la semana 52.

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarker research

Investigación de biomarcadores

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

Australia

Austria

Belgium

Brazil

Finland

France

Germany

Italy

Japan

Netherlands

Poland

Russian Federation

Spain

Switzerland

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

End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient.

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.

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

475

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

357

F.4.2.2

In the whole clinical trial

500

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)

NONE

Ninguno

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

2018-04-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-09

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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