Clinical Trials Register

Summary
EudraCT Number:	2020-004068-24
Sponsor's Protocol Code Number:	D325BC00001
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:	2021-08-02
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

2020-004068-24

A.3

Full title of the trial

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE)

Studio di fase III multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, di 52 settimane, con estensione in aperto per valutare l’efficacia e la sicurezza di benralizumab in pazienti con bronchiectasia non correlata alla fibrosi cistica (MAHALE)

A.3.1

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

Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis

Efficacia e sicurezza di benralizumab in pazienti con bronchiectasia non correlata alla fibrosi cistica

A.3.2

Name or abbreviated title of the trial where available

MAHALE

A.4.1

Sponsor's protocol code number

D325BC00001

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	ASTRAZENECA AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Infromation Center
B.5.3	Address:
B.5.3.1	Street Address	N/A
B.5.3.2	Town/ city	Södertälje
B.5.3.3	Post code	SE-151 85
B.5.3.4	Country	Sweden
B.5.4	Telephone number	0000000
B.5.5	Fax number	0000000
B.5.6	E-mail	information.center@astrazeneca.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	No
D.2.1.1.1	Trade name	NA
D.2.1.1.2	Name of the Marketing Authorisation holder	NA
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	benralizumab
D.3.2	Product code	[MEDI-563]
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	benralizumab
D.3.9.1	CAS number	1044511-01-4
D.3.9.2	Current sponsor code	MEDI-563
D.3.9.3	Other descriptive name	benralizumab
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
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	Yes
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.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.2.5	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	Atropina
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
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	up to
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	Yes
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	Antistaminici H1 - H2
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.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	300
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: 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	Yes
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	C01CA04 - Dopamina
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Concentrate and solvent for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1350
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: 5
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.2.5	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	Adrenalina
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	na
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	5
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: 6
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.2.5	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	Salbutamolo
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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: 7
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.2.5	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	H02 - Corticosteroidi Sistemici
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
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	up to
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: 8
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.2.5	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	Ossigeno - ATC V03AN01
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Medicinal gas, compressed
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	200
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: 9
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.2.5	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	SODIO CLORURO 0,9%
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	3000
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: 10
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.2.5	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	Glucagone
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Powder and solvent for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
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	up to
D.3.10.3	Concentration number	2
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

Non-cystic fibrosis bronchiectasis (NCFB)

bronchiectasia non correlata alla fibrosi cistica

E.1.1.1

Medical condition in easily understood language

Non-cystic Fibrosis Bronchiectasis (NCFB)

bronchiectasia non correlata alla fibrosi cistica

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10038738
E.1.2	Term	Respiratory, thoracic and mediastinal disorders
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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

To evaluate the effect of benralizumab on bronchiectasis exacerbations - annualised exacerbation rate at Week 52

valutare l’efficacia e la sicurezza di benralizumab in pazienti con bronchiectasia non correlata alla fibrosi cistica

E.2.2

Secondary objectives of the trial

To evaluate the effect of benralizumab on:

- time to onset of bronchiectasis exacerbations
- respiratory symptoms
- pulmonary function
- cough-related quality of life
- severe bronchiectasis exacerbations
- rate of hospitalizations due to bronchiectasis exacerbations
- the frequency of antibiotic use for bronchiectasis exacerbations
- bronchiectasis health-related quality of life
- respiratory health status/health-related quality of life
- NCFB related healthcare resource utilisation

To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of benralizumab

Valutare gli effetti di benralizumab su:
- tempo di insorgenza delle esacerbazioni della bronchiectasia
- sui sintomi respiratori
- sulla funzionalità polmonare
- qualità della vita correlata alla tosse
- esacerbazione severa della bronchiectasia
- tasso di ospedalizzazione dovuto ad esacerbazione della bronchiectasia
-frequenza nell'uso di antibiotici per esacerbazione della bronchiectasia
-qualità della vita correlata alla presenza di bronchiectasie
- stato di salute respiratoria / qualità della vita correlata alla salute
- Utilizzo delle risorse sanitarie correlate all'NCFB

Per valutare la sicurezza, la tollerabilità, la farmacocinetica e l'immunogenicità di benralizumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female, at least 18 years of age inclusive at the time of signing the ICF

- Must have NCFB diagnosed by a physician and confirmed by CT (measured at screening; if a new CT is not possible, a CT performed within 12 months of the screening visit is acceptable).

- Documented history of 2 or more bronchiectasis exacerbations within a year of the screening visit.

- If receiving prophylactic systemic or inhaled antibiotics to prevent bronchiectasis exacerbations, the dose/regimen must be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study. If prophylactic macrolides have been recently discontinued, patients must have been off treatment for at least 3 months prior to randomisation. In all other cases of prophylactic antibiotic use, = 4 weeks wash out period should be in place after the last dose of antibiotic and prior to randomisation

- Must be on airway clearance therapy, physiotherapy, or mucus clearance therapy.The dose and regimen of these therapies and any drugs used to aid expectoration should be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study.

- If receiving inhaled corticosteroid or bronchodilator therapy, the dose and regimen should be stable with no alteration to dose or formulation for at least 3 months prior to the screening visit and this should remain stable throughout the DB period of the study.

- Women of childbearing potential (WOCBP) must have a negative serum and urine pregnancy test prior to randomization and agree to use a highly effective method of birth control from enrollment, throughout the study duration, and for 12 weeks after the last dose of IP.

- Maschio o femmina, almeno 18 anni di età compiuti al momento della sottoscrizione dell'ICF
- NCFB diagnosticata da un medico e confermata dalla TC (valutata allo screening; se una nuova TC non è possibile, è accettabile una TC eseguita entro 12 mesi dalla visita di screening).
- Storia documentata di 2 o più esacerbazioni di bronchiectasie entro un anno dalla visita di screening.
- In caso di somministrazione profilattica di antibiotici sistemici o inalatori per prevenire le esacerbazioni delle bronchiectasie, la dose / regime deve essere stabile per almeno 3 mesi prima della visita di screening e rimanere stabile per tutto il periodo DB dello studio. Se la profilassi dei macrolidi è stata interrotta di recente, i pazienti devono essere interrotti dal trattamento per almeno 3 mesi prima della randomizzazione. In tutti gli altri casi di uso profilattico di antibiotici, deve essere previsto un periodo wash out maggiore o uguale di 4 settimane dopo l'ultima dose di antibiotico e prima della randomizzazione
- Deve essere sottoposto a terapia per la clearance delle vie aeree, fisioterapia o terapia per la clearance del muco. La dose e il regime di queste terapie e di tutti i farmaci usati per aiutare l'espettorazione devono essere stabili almeno 3 mesi prima della visita di screening e rimanere stabili per tutto il periodo lo studio.
- Se si riceve una terapia con corticosteroidi inalatori o broncodilatatori, la dose e il regime devono essere stabili senza variazioni della dose o della formulazione per almeno 3 mesi prima della visita di screening e questo deve rimanere stabile per tutto il periodo DB dello studio.
- Le donne in età fertile devono aver effettuato un test di gravidanza su siero e urine con risultato negativo prima della randomizzazione e accettare di utilizzare un metodo contraccettivo altamente efficace sin dall'arruolamento, per tutta la durata dello studio e per 12 settimane dopo l'ultima dose di IP.

E.4

Principal exclusion criteria

- Pulmonary disease other than bronchiectasis. Patients with a history of NTM disease may be enrolled if they have completed treatment prior to the Screening visit, if at least 3 months have elapsed since the last day of antibiotic treatment for NTM at the Screening visit, and if they have had a negative sputum culture prior to the screening visit.

- Another diagnosed or suspected pulmonary or systemic disease associated with elevated peripheral eosinophil counts

- Respiratory infection or bronchiectasis exacerbation during the screening period.

- Any other clinical condition that is not stable in the opinion of the Investigator and could:
a. Affect the safety of the patient during the study.
b. Influence the findings of the study or their interpretation.
c. Impede the patient’s ability to complete the entire duration of the study.

- Radiological findings suggestive of a respiratory disease other than bronchiectasis, suggestive of acute infection, or of solitary pulmonary nodules without appropriate follow up and demonstration of stability as per standard of care. Pulmonary nodules > 6 mm in size should have at least 2 years of follow up with no change on CT imaging.

- Current active liver disease

- Current malignancy, or history of malignancy, except for:
a. Patients who have had basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided the patient is in remission and curative therapy was completed at least 12 months prior to Visit 1
b. Patients who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to Visit 1.

- History of known immunodeficiency disorder including a positive test for human immunodeficiency virus, HIV-1 or HIV-2.

- History of alcohol or drug abuse within the past year

- Patients receiving long-term oxygen treatment

- Patients participating in, or scheduled for, an intensive (active) pulmonary rehabilitation programme. Patients who are in the maintenance phase of a rehabilitation programme are eligible.

- Use of non-invasive positive-pressure ventilation for conditions other than obstructive sleep apnoea

- Use of immunosuppressive medication within 3 months of the screening visit or expected need for chronic use (= 4 weeks) during study

- Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within one year of the screening visit

- Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to randomisation

- Receipt of immunoglobulin and blood products within 30 days of the date of the screening visit

- Receipt of live attenuated vaccines within 30 days of the date of randomisation

- Concurrent enrolment in another clinical drug interventional trial

- History of anaphylaxis to any biologic therapy or vaccine

- Known history of allergy or reaction to any component of the IP formulation.

- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)

- Judgement by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements

- Previous randomisation in the present study

- Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.

- Malattia polmonare diversa dalle bronchiectasie. I pazienti con una storia di malattia da NTM possono essere arruolati se hanno completato il trattamento prima della visita di screening, se sono trascorsi almeno 3 mesi dall'ultimo giorno di trattamento antibiotico per NTM alla visita di screening e se hanno avuto un risultato negativo nell'analisi dell' espettorato prima della visita di screening.

- Un'altra malattia polmonare o sistemica diagnosticata o sospetta associata a conta degli eosinofili periferici elevata

- Infezione respiratoria o esacerbazione delle bronchiectasie durante il periodo di screening.

- Qualsiasi altra condizione clinica che non è stabile secondo il parere dello sperimentatore e potrebbe:
a. Influire sulla sicurezza del paziente durante lo studio.
b. Influenzare i risultati dello studio o la loro interpretazione.
c. Impedire al paziente di completare la sperimentazione.

- Reperti radiologici indicativi di una malattia respiratoria diversa dalle bronchiectasie, indicativi di infezione acuta o di noduli polmonari solitari senza un appropriato follow-up e dimostrazione di stabilità come da standard di cura. I noduli polmonari di dimensioni> 6 mm devono avere almeno 2 anni di follow-up senza modifiche all'imaging TC.

- malattia epatica attiva

- Malignità , o storia di malignità, ad eccezione di:
a. I pazienti che hanno avuto carcinoma a cellule basali, carcinoma della pelle a cellule squamose localizzato o carcinoma in situ della cervice sono eleggibili a condizione che il paziente sia in remissione e la terapia curativa sia stata completata almeno 12 mesi prima della Visita 1
b. I pazienti che hanno avuto altri tumori maligni sono eleggibili a condizione che il partecipante sia in remissione e la terapia curativa sia stata completata almeno 5 anni prima della Visita 1.

- Anamnesi di disturbo da immunodeficienza noto, compreso un test positivo per il virus dell'immunodeficienza umana, HIV-1 o HIV-2.

- Storia di abuso di alcol o droghe nell'ultimo anno

- Pazienti che ricevono un trattamento con ossigeno a lungo termine

- Pazienti che partecipano o programmano un programma di riabilitazione polmonare intensivo (attivo). Sono ammissibili i pazienti che si trovano nella fase di mantenimento di un programma di riabilitazione.

- Uso della ventilazione a pressione positiva non invasiva per condizioni diverse dall'apnea ostruttiva del sonno

- Uso di farmaci immunosoppressori entro 3 mesi dalla visita di screening o necessità prevista di uso cronico (= 4 settimane) durante lo studio

- Ricezione di qualsiasi prodotto biologico commercializzato o sperimentale (anticorpo monoclonale o policlonale) entro un anno dalla visita di screening

- Ricezione di qualsiasi prodotto non biologico sperimentale entro 30 giorni o 5 emivite prima della randomizzazione

- Ricezione di immunoglobuline e prodotti sanguigni entro 30 giorni dalla data della visita di screening

- Ricezione di vaccini vivi attenuati entro 30 giorni dalla data di randomizzazione

- Iscrizione simultanea in un altro studio clinico interventistico sui farmaci

- Storia di anafilassi a qualsiasi terapia biologica o vaccino

- Storia nota di allergia o reazione a qualsiasi componente della formulazione IP.

- Coinvolgimento nella pianificazione e / o conduzione dello studio (vale sia per il personale di AstraZeneca che per il personale presso il sito dello studio)

- Giudizio dello sperimentatore che il paziente non dovrebbe partecipare allo studio se è improbabile che il paziente rispetti le procedure, le restrizioni e i requisiti dello studio

- Precedente randomizzazione nel presente studio

- donne in stato di gravidanza (confermata con test di gravidanza positivo) o in allattamento.

E.5 End points

E.5.1

Primary end point(s)

Annualised bronchiectasis exacerbation rate at Week 52

Tasso annualizzato di esacerbazione delle bronchiectasie alla settimana 52

E.5.1.1

Timepoint(s) of evaluation of this end point

over the 52-week treatment period

durante il periodo di trattamento di 52 settimane

E.5.2

Secondary end point(s)

Key secondary endpoints:

- Time to first bronchiectasis exacerbation

- Change from baseline in Quality of Life-Bronchiectasis-Respiratory Symptoms (QoL-B-RSS)

- Change from baseline in pre-dose forced expiratory volume in 1 second (FEV1)

Other endpoints:

- Change from baseline in Leicester Cough Questionnaire (LCQ)

- Annualised rate of severe bronchiectasis exacerbations and annualised rate of hospitalisations due to bronchiectasis exacerbations

- Frequency of antibiotic use for bronchiectasis exacerbations

- Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS key secondary endpoint)

- Change from baseline in St. George's Respiratory Questionnaire (SGRQ)

- Frequency and annual rate of NCFB related healthcare encounters (hospitalisation, ICU stay, emergency room visits, urgent care, specialist/GP visits, home healthcare), tests/procedures
Total hospital length of stay

- Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical laboratory assessments, physical examinations, and ECGs

Endpoint secondari chiave:

- Tempo alla prima esacerbazione delle bronchiectasie

- Variazione rispetto al basale della qualità della vita-bronchiectasie-sintomi respiratori (QoL-B-RSS)

- Variazione dal basale del volume espiratorio forzato pre-dose in 1 secondo (FEV1)

Altri endpoint:

- Variazione rispetto al basale nel Leicester Cough Questionnaire (LCQ)

- Tasso annualizzato di riacutizzazioni gravi di bronchiectasie e tasso annualizzato di ricoveri dovuti a riacutizzazioni di bronchiectasie

- Frequenza dell'uso di antibiotici per le riacutizzazioni di bronchiectasie

- Variazione rispetto al basale nelle scale Qualità della vita-Bronchiectasie (QoL-B) (escluso endpoint secondario chiave QoL-B-RSS)

- Variazione rispetto al basale nel questionario respiratorio di San Giorgio (SGRQ)

- Frequenza e tasso annuo di incontri sanitari correlati alla BCNF (ricovero in ospedale, ricovero in terapia intensiva, visite al pronto soccorso, cure urgenti, visite specialistiche / GP, assistenza domiciliare), test / procedure
Durata totale della degenza ospedaliera

- La sicurezza e la tollerabilità saranno valutate in termini di eventi avversi, segni vitali, valutazioni cliniche di laboratorio, esami fisici ed ECG

E.5.2.1

Timepoint(s) of evaluation of this end point

Varies depending on the endpoint/objective

Varia a seconda dell'endpoint / obiettivo

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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

Australia

Canada

China

India

Korea, Republic of

Philippines

Russian Federation

United States

Vietnam

Denmark

Germany

Italy

Poland

Spain

United Kingdom

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

The end of study is defined as the last expected visit/contact of the last patient undergoing the study.

La fine dello studio è definita come l'ultima visita / contatto previsto dell'ultimo paziente sottoposto allo studio.

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:

101

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

319

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

119

F.4.2.2

In the whole clinical trial

420

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.

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

2021-05-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-18

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

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Orphan Designation Number:
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