Clinical Trials Register

Summary
EudraCT Number:	2017-004574-34
Sponsor's Protocol Code Number:	I4V-MC-JAIN
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-15
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

Italy - Italian Medicines Agency

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

Studio multicentrico di fase 3, randomizzato, in doppio cieco controllato con placebo per la valutazione della sicurezza e dell¿efficacia di Baricitinib in combinazione con corticosteroidi topici in pazienti con dermatite atopica da moderata a grave che abbiano fallito, presentino intolleranza o controindicazioni al trattamento con la 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

Uno studio a lungo termine su Baricitinib (LY3009104) con corticosteroidi topici in adulti con dermatite atopica da moderata a severa non controllata con la ciclosporina A o per coloro che non possono assumere la ciclosporina A per via orale poich¿ non ¿ medicalmente raccomandabile

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	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
B.1.3.4	Country	United States
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
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center, DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	46285
B.5.3.4	Country	United States
B.5.4	Telephone number	00390554257386
B.5.5	Fax number	00390554257348
B.5.6	E-mail	EU_Lilly_Clinical_Trials@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.3.9.2	Current sponsor code	LY3009104
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.3.9.2	Current sponsor code	LY3009104
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	baricitinib
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.3.9.2	Current sponsor code	LY3009104
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Dermatite atopica

E.1.1.1

Medical condition in easily understood language

Atopic dermatitis also known as Eczema

Dermatite atopica nota anche come 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	21.1
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

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

Testare l¿ipotesi che baricitinib 4 mg + corticosteroidi topici (TCS) o baricitinib 2 mg + TCS sia superiore rispetto a placebo + TCS nel trattamento della dermatite atopica da moderata a severa

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.

¿ Testare l¿ipotesi che baricitinib 1 mg + corticosteroidi topici (TCS) sia superiore rispetto a placebo + TCS nel trattamento di pazienti con dermatite atopica da moderata a severa.
¿ Confrontare l¿efficacia di baricitinib 4 mg + TCS, baricitinib 2 mg + TCS, o baricitinib 1 mg + TCS rispetto a placebo + TCS nel trattamento della dermatite atopica nel periodo di trattamento in doppio cieco controllato con placebo in termini di miglioramento dei segni e dei sintomi della dermatite atopica.
¿ Confrontare l¿efficacia di baricitinib 4 mg + TCS, baricitinib 2 mg + TCS, o baricitinib 1 mg + TCS rispetto a placebo + TCS nel trattamento della dermatite atopica nel periodo di trattamento in doppio cieco controllato con placebo in termini di misure di outcome riferiti dai pazienti.

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

Other types of substudies
Specify title, date and version of each substudy with relative 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.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio randomizzato di riduzione della titolazione alla settimana 52.
Durante l¿estensione a lungo termine (periodo 3), i pazienti eleggibili parteciperanno a un sottostudio di riduzione della titolazione. L¿obiettivo del sottostudio ¿ di valutare la possibilit¿ di mantenere l¿efficacia con una dose inferiore di baricitinib nei pazienti con risposta (punteggio IGA pari a 0 o 1) o risposta parziale (IGA 2) a baricitinib 2 mg una volta/die o 4 mg una volta/die in associazione a corticosteroidi topici.

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.

• Diagnosi di eczema atopico da moderato a severo (dermatite atopica) da almeno 12 mesi.
• Risposta inadeguata o intolleranza a farmaci topici (per applicazione cutanea ) esistenti
nei 6 mesi precedenti lo screening.
• Pazienti che intendono interrompere determinati trattamenti per l’eczema (quali i trattamenti sistemici e topici durante un periodo di washout e nel corso dello studio).
• Pazienti che acconsentono a utilizzare emollienti quotidianamente.
• Controindicazione medica a ciclosporina A, o intolleranza e/o tossicità inaccettabile o risposta inadeguata a ciclosporina A in passato.

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.

• Presenza attuale o anamnesi di altre condizioni cutanee concomitanti (ad es. psoriasi o lupus eritematoso), o anamnesi di patologia cutanea eritrodermica, refrattaria o instabile che richiede frequenti ricoveri ospedalieri e/o trattamento endovenoso per infezioni cutanee.
• Anamnesi di eczema erpetico negli ultimi 12 mesi, e/o anamnesi di 2 o più episodi di eczema erpetico in passato.
• Partecipanti che sperimentano attualmente un’infezione cutanea che richiede trattamento, o che sono attualmente trattati con antibiotici topici o sistemici.
• Patologia seria che si prevede richiederà l’uso di corticosteroidi sistemici, o interferirà in qualche modo con la partecipazione allo studio, o richiederà un monitoraggio attivo frequente (ad es. asma cronica instabile).
• Trattamento precedente con le seguenti terapie:
- Anticorpo monoclonale per meno di 5 emivite precedenti la randomizzazione.
- Trattamento precedente con un inibitore orale delle Janus chinasi (JAK).
- Pazienti che hanno ricevuto corticosteroidi per via parenterale somministrati mediante iniezione intramuscolare o endovenosa (ev) nelle 2 settimane precedenti l’ingresso nello studio o nei 6 mesi precedenti la randomizzazione pianificata, o per i quali si prevede la necessità di iniezione parenterale di corticosteroidi durante lo studio.
- Iniezione intrarticolare di corticosteroide nelle 2 settimane precedenti l’ingresso nello studio o nei 6 mesi precedenti la randomizzazione pianificata.

• Pressione arteriosa elevata caratterizzata da ripetuta pressione arteriosa sistolica >160 millimetri di mercurio (mmHg) o pressione arteriosa diastolica >100 mmHg.
• Intervento chirurgico importante nelle ultime otto settimane o pianificato durante lo studio.
• Pazienti che hanno sperimentato una delle seguenti condizioni nelle 12 settimane precedenti lo screening: evento tromboembolico venoso (VTE), infarto miocardico (IM), cardiopatia ischemica instabile, ictus, o insufficienza cardiaca di classe III/IV secondo la New York Heart Association.
• Pazienti con anamnesi di recidive di TEV (= 2), o considerati ad alto rischio di TEV secondo il giudizio dello sperimentatore.
• Anamnesi o presenza di malattia cardiovascolare, respiratoria, epatica o epatica cronica, malattia gastrointestinale, endocrina, ematologica, neurologica, linfoproliferativa, disturbi neuropsichiatrici o altre patologie serie e/o instabili.
• Infezione clinicamente seria attuale o recente di natura virale, batterica, fungina o parassitaria, tra cui herpes zoster e tubercolosi.
• Anomalie di laboratorio specifiche.
• Determinati trattamenti che sono controindicati.
• Gravidanza o allattamento.

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

Percentuale di pazienti che hanno raggiunto un Investigator’s Global Assessment (IGA) pari a 0 o 1 con un miglioramento di almeno 2 punti

E.5.1.1

Timepoint(s) of evaluation of this end point

week 16

settimana 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)
¿ Percentuale di pazienti che hanno raggiunto un Investigator¿s Global Assessment (IGA) pari a 0 o 1 con un miglioramento di almeno 2 punti
¿ Percentuale di pazienti che hanno ottenuto una risposta EASI75
¿ Percentuale di pazienti che hanno ottenuto una risposta EASI 90
¿ Variazione media rispetto al basale nel punteggio EASI
¿ Percentuale di pazienti che hanno ottenuto una risposta SCORAD75
¿ Variazione media rispetto al basale nell¿NRS dolore cutaneo
; 2) Percentuale di pazienti che hanno raggiunto un miglioramento di 4 punti nell¿NRS prurito
; 3) Variazione media rispetto al basale nel punteggio dell¿item 2 della scala ADSS; 4)
¿ Percentuale di pazienti che hanno raggiunto un punteggio IGA pari a 0 o 1 con un miglioramento di almeno 2 punti rispetto al basale
¿ Percentuale di pazienti che hanno ottenuto una risposta EASI75

E.5.2.1

Timepoint(s) of evaluation of this end point

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

valutato alla settimana 16; valutato alle settimane 16, 4, 2 ed 1; valutato a 16 settimane e 1 settimana; valutazione a 52 settimane.

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

Ricerca sui biomarcatori

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

Information not present in EudraCT

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

Brazil

Japan

Russian Federation

Austria

Belgium

Finland

France

Germany

Italy

Netherlands

Poland

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.

La fine dello studio ¿ la data dell'ultima visita o l'ultima procedura programmata mostrata nella tabella delle attivit¿ per l'ultimo paziente.

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

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

nessuno

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

2018-04-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-18

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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