Clinical Trials Register

Summary
EudraCT Number:	2021-004315-76
Sponsor's Protocol Code Number:	EFC16973
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:	2021-11-17
Trial 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

2021-004315-76

A.3

Full title of the trial

Master protocol of two randomized, double blind, placebo-controlled, multicenter, parallel group studies to evaluate the efficacy and safety of dupilumab in adult patients with chronic pruritus of unknown origin (CPUO)

Protocollo principale di due studi randomizzati, in doppio cieco, controllati con placebo, multicentrici, a gruppi paralleli per valutare l’efficacia e la sicurezza di dupilumab in pazienti adulti con prurito cronico di origine sconosciuta (CPUO)

A.3.1

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

Efficacy and safety of subcutaneous dupilumab for the treatment of adult participants with chronic pruritus of unknown origin (CPUO)

Efficacia e sicurezza di dupilumab per via sottocutanea per il trattamento di partecipanti adulti con prurito cronico di origine sconosciuta (CPUO)

A.3.2

Name or abbreviated title of the trial where available

LIBERTY-CPUO-CHIC

A.4.1

Sponsor's protocol code number

EFC16973

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1253-9888

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	SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
B.1.3.4	Country	France
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	Sanofi-aventis Recherche & Développement
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SANOFI S.r.l
B.5.2	Functional name of contact point	CONTACT POINT
B.5.3	Address:
B.5.3.1	Street Address	VIALE LUIGI BODIO 37/B
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20158
B.5.3.4	Country	Italy
B.5.4	Telephone number	800536389
B.5.5	Fax number	000000000
B.5.6	E-mail	informazioni.medicoscientifiche@sanofi.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	FEXOFENADINA
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	FEXOFENADINA
D.3.2	Product code	[NA]
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	FEXOFENADINA CLORIDRATO
D.3.9.2	Current sponsor code	na
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	180
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	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	Dupilumab
D.3.2	Product code	[SAR231893]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	dupilumab
D.3.9.2	Current sponsor code	SAR231893
D.3.9.3	Other descriptive name	REGN668
D.3.9.4	EV Substance Code	SUB88511
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	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic pruritus of unknown origin (CPUO)

Prurito cronico di origine sconosciuta (CPUO)

E.1.1.1

Medical condition in easily understood language

Chronic pruritus of unknown origin (CPUO)

Prurito cronico di origine sconosciuta (CPUO)

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	24.1
E.1.2	Level	PT
E.1.2	Classification code	10037087
E.1.2	Term	Pruritus
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Study A and B:
• To demonstrate the efficacy of dupilumab on itch response in participants with CPUO

Studio A e B:
• Dimostrare l’efficacia di dupilumab sulla risposta al prurito nei/nelle partecipanti affetti/e da CPUO

E.2.2

Secondary objectives of the trial

Study A and B:
• To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with CPUO
• To demonstrate the improvement in sleep, anxiety and depression, and health-related quality of life (HRQoL)
• To evaluate safety outcome measures
• To evaluate immunogenicity of dupilumab

Studio A e B:
• Dimostrare l’efficacia di dupilumab su endpoint aggiuntivi di prurito nei/nelle partecipanti affetti/e da CPUO
• Dimostrare il miglioramento del sonno, dell’ansia e della depressione e della qualità della vita correlata alla salute (HRQoL)
• Valutare le misure di esito della sicurezza
• Valutare l’immunogenicità di dupilumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent.
- Participants with chronic pruritus for at least 6 months before the screening visit.
- Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs).
- Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.
- History of insufficient control of the chronic pruritus with prior treatment.
- Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency).
- Participants must have a history of severe itch and a worst itch score of >/=7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient global impression of severity (PGIS) of pruritus scored "severe" at screening.
- Participants must have an average worst itch score of >/=7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS.
- Participants scored "severe" in the PGIS of pruritus on Day 1.

- Il/La partecipante deve avere da 18 (o l’età legale del consenso nella giurisdizione in cui si svolge lo studio) a 90 anni di età compresi al momento della firma del consenso informato.
- Partecipanti con prurito cronico da almeno 6 mesi prima della visita di screening.
- Prurito cronico considerato di origine ignota secondo la valutazione dello sperimentatore al basale (escluso prurito cronico secondario a condizioni dermatologiche o sistemiche, di origine neuropatica o psicogena o secondario a farmaci).
- Il prurito cronico deve interessare almeno 2 delle seguenti aree del corpo: gambe, braccia o tronco.
- Anamnesi di controllo insufficiente del prurito cronico con il trattamento precedente.
- I/Le partecipanti devono ricevere un trattamento ottimale per condizioni concomitanti che potrebbero influire sul prurito (per es., diabete, carenza di ferro).
- I/Le partecipanti devono presentare un’anamnesi di prurito grave e un punteggio di prurito peggiore >/= 7 allo screening sulla scala WI-NRS (scala di punteggio da 0 a 10; un punteggio più alto indica un prurito peggiore) e nell’Impressione globale del paziente in merito alla gravità (PGIS) del prurito, un punteggio del prurito "grave" allo screening.
- I/Le partecipanti devono avere un punteggio medio del prurito peggiore >/= 7 nei 7 giorni precedenti la visita preliminare e nei 7 giorni precedenti il Giorno 1 sulla scala WI-NRS.
- I/Le partecipanti hanno ottenuto un punteggio “grave” nel PGIS del prurito il Giorno 1.

E.4

Principal exclusion criteria

- Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.
- Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent.
- Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit.
- HIV infection.
- Severe renal failure (dialysis).
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit.
- Known or suspected immunodeficiency.
- Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
- History of hypersensitivity or intolerance to non-sedative antihistamines.
- Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.

- Grave/i malattia/e concomitante/i che, a giudizio dello sperimentatore, possa/possano influire negativamente sulla partecipazione del/della paziente allo studio.
- I/Le pazienti con tubercolosi attiva o con infezione da micobatteri non tubercolari, o anamnesi di tubercolosi trattata in maniera incompleta, a meno che non sia ben documentato da uno specialista che il/la partecipante è stato/a adeguatamente trattato/a e può ora iniziare il trattamento con un agente biologico.
- Diagnosi, sospetta o ad alto rischio di infezione endoparassitaria e/o uso di farmaci antiparassitari nelle 2 settimane precedenti la visita di screening.
- Infezione da HIV.
- Grave insufficienza renale (dialisi).
- Infezione cronica in fase attiva o acuta che richieda un trattamento con antibiotici sistemici, antivirali o antimicotici nelle 2 settimane precedenti la visita preliminare.
- Nota o sospetta immunodeficienza.
- Malignità attiva o anamnesi di malignità nei 5 anni precedenti la visita basale a eccezione del carcinoma della cervice in situ completamente trattato e del carcinoma squamoso o basocellulare della pelle, non metastatico, completamente trattato e risolto.
- Anamnesi di ipersensibilità o intolleranza agli antistaminici non sedativi.
- Partecipazione a precedenti studi clinici con dupilumab o a trattamenti con dupilumab disponibile in commercio.

E.5 End points

E.5.1

Primary end point(s)

1 - Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by >/= 4 from baseline to Week 12; WI-NRS is a patient reported outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
2 - Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by >/= 4 from baseline to Week 12; WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

1 – Studio A: Percentuale di partecipanti con miglioramento (riduzione) nella media settimanale della scala di valutazione numerica giornaliera del peggior prurito (WI-NRS) >/= 4 dal basale alla Settimana 12; WI-NRS è un esito riferito dal paziente (PRO) composto da un singolo elemento valutato su una scala da 0 (“Nessun prurito”) a 10 (“Peggior prurito immaginabile”).
2 – Studio B: Percentuale di partecipanti con miglioramento (riduzione) nella media settimanale della scala giornaliera WI-NRS da >/= 4 dal basale alla Settimana 12; WI-NRS è un PRO composto da un singolo elemento valutato su una scala da 0 (“Nessun prurito”) a 10 (“Peggior prurito immaginabile”).

E.5.1.1

Timepoint(s) of evaluation of this end point

1,2: Baseline to Week 12

1,2: dalla Basale alla settimana 12

E.5.2

Secondary end point(s)

1 - Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at Week 12.
2 - Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12.
3 - Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12.
4 - Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by >/= 4 from baseline to Week 24.
5 - Study A: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 24.
6 - Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by >/=4 from baseline over time until Week 24.
7 - Study A: Time to first response of WI-NRS >/= 4 points reduction from baseline by Week 24.
8 - Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24.
9 - Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24.
10 - Study A: Absolute change from baseline in weekly average of daily sleep disturbances numerical rating scale (NRS) at Week 12.
11 - Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12.
12 - Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 12.
13 - Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 12.
14 - Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 12.
15 - Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 24.
16 - Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 24.
17 - Study A: Change from baseline in DLQI score at Week 24.
18 - Study A: Change from baseline in the ItchyQoL score at Week 24.
19 - Study A: Change from baseline in HADS total score at Week 24.
20 - Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS).
21 - Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab.
22 - Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12.
23 - Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12.
24 - Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12.
25 - Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by >/= 4 from baseline over time until Week 12.
26 - Study B: Time to first response of WI-NRS >/= 4 points reduction from baseline by Week 12.
27 - Study B: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 12.
28 - Study B: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12.
29 - Study B: Change from baseline in DLQI score at Week 12.
30 - Study B: Change from baseline in the ItchyQoL score at Week 12.
31 - Study B: Change from baseline in HADS total score at Week 12.
32 - Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS.
33 - Study B: Incidence of treatment-emergent ADA against dupilumab.

Studio A
1 - Percentuale di partecipanti che hanno ottenuto un punteggio “nessuno” o “lieve” nell’Impressione globale del/la paziente sulla gravità (PGIS) del prurito alla Settimana 12.
2 - Variazione assoluta rispetto al basale nella media settimanale della WI-NRS giornaliera alla Settimana 12.
3 - Variazione percentuale rispetto al basale nella media settimanale della WI-NRS giornaliera alla Settimana 12.
4 - Percentuale di partecipanti con miglioramento (riduzione) nella media settimanale della WI-NRS giornaliera da >/= 4 dal basale alla Settimana 24.
5 - Percentuale di partecipanti che hanno ottenuto un punteggio “nessuno” o “lieve” nella PGIS del prurito alla Settimana 24.
6 - Percentuale di partecipanti con miglioramento (riduzione) della media settimanale della WI-NRS giornaliera >/= 4 rispetto al basale per tutto il tempo fino alla Settimana 24.
7 - Tempo alla prima risposta di riduzione >/= 4 punti della WI-NRS rispetto al basale entro la Settimana 24.
8 - Variazione assoluta rispetto al basale nella media settimanale della WI-NRS giornaliera alla Settimana 24.
9 - Variazione percentuale rispetto al basale nella media settimanale della WI-NRS giornaliera alla Settimana 24.
10 - Variazione assoluta rispetto al basale nella media settimanale della scala di valutazione numerica (NRS) dei disturbi del sonno giornalieri alla Settimana 12.
11 - Variazione percentuale rispetto al basale nella media settimanale dei disturbi del sonno giornalieri NRS alla Settimana 12.
12 - Variazione rispetto al basale alla Settimana 12 nel punteggio dell’indice dermatologico della qualità di vita (DLQI).
13 - Variazione rispetto al basale nel punteggio della Qualità della vita pruriginosa (ItchyQoL) alla Settimana 12.
14 - Variazione rispetto al basale nel punteggio totale della Scala della depressione e dell’ansia da ospedale (HADS) alla Settimana 12.
15 - Variazione assoluta rispetto al basale nella media settimanale dei disturbi del sonno giornalieri NRS alla Settimana 24.
16 - Variazione percentuale rispetto al basale nella media settimanale dei disturbi del sonno giornalieri NRS alla Settimana 24.
17 - Variazione rispetto al basale del punteggio DLQI alla Settimana 24.
18 - Variazione rispetto al basale nel punteggio ItchyQoL alla Settimana 24.
19 - Variazione rispetto al basale del punteggio HADS totale alla Settimana 24.
20 - Percentuale di partecipanti che manifestano eventi avversi emergenti dal trattamento (TEAE) o eventi avversi seri (SAE) dal basale fino alla fine dello studio (EOS).
21 - Incidenza di anticorpi antifarmaco (ADA) emergenti dal trattamento contro dupilumab.
Studio B
22 - Percentuale di partecipanti che hanno ottenuto un punteggio “nessuno” o “lieve” nella PGIS del prurito alla Settimana 12.
23 - Variazione assoluta rispetto al basale nella media settimanale della WI-NRS giornaliera alla Settimana 12.
24 - Variazione percentuale rispetto al basale nella media settimanale della WI-NRS giornaliera alla Settimana 12.
25 - Percentuale di partecipanti con miglioramento (riduzione) della media settimanale della WI-NRS giornaliera da >/= 4 rispetto al basale per tutto il tempo fino alla Settimana 12.
26 - Tempo alla prima risposta di riduzione >/= 4 punti della WI-NRS rispetto al basale entro la Settimana 12.
27 - Variazione assoluta rispetto al basale nella media settimanale dei disturbi del sonno giornalieri NRS alla Settimana 12.
28 - Variazione percentuale rispetto al basale nella media settimanale dei disturbi del sonno giornalieri NRS alla Settimana 12.
29 - Variazione rispetto al basale nel punteggio DLQI alla Settimana 12.
30 - Variazione rispetto al basale nel punteggio ItchyQoL alla Settimana 12.
31 - Variazione rispetto al basale nel punteggio totale HADS alla Settimana 12.
32 - Percentuale di partecipanti che manifestano TEAE o SAE dal basale fino alla EOS.
33 - Incidenza di anticorpi antifarmaco (ADA) emergenti dal trattamento contro dupilumab.

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 22 : Week 12
2, 3, 10, 11, 12, 13, 14, 23, 24, 25, 26, 27, 28, 29, 30, 31 : Baseline to Week 12
4, 6, 7, 8, 9, 15, 16, 17, 18, 19, 32, 33 : Baseline to Week 24
5 : Week 24
20, 21 : Baseline to Week 36

1, 22 : Settimana 12
2, 3, 10, 11, 12, 13, 14, 23, 24, 25, 26, 27, 28, 29, 30, 31 : Dal basale alla settimana 12
4, 6, 7, 8, 9, 15, 16, 17, 18, 19, 32, 33 : Dal basale alla settimana 24
5 : Settimana 24
20, 21 : Dal basale alla settimana 36

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

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

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

Canada

China

Japan

Korea, Republic of

United States

France

Germany

Hungary

Italy

Poland

Spain

Argentina

E.8.7

Trial has a data monitoring committee

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

LVLS

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:

227

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

226

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

213

F.4.2.2

In the whole clinical trial

453

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

2022-01-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-02

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

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