Clinical Trials Register

Summary
EudraCT Number:	2021-003338-35
Sponsor's Protocol Code Number:	D7552C00001
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:	2022-09-13
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

2021-003338-35

A.3

Full title of the trial

A Phase 2, Randomised, Double-Blind, Placebo and Active Comparator-Controlled Study to Assess Efficacy and Safety of Multiple Dose Levels of AZD5718 Given Orally Once Daily for Twelve Weeks in Adults with Moderate-to-Severe Uncontrolled Asthma

Studio di fase 2, randomizzato, in doppio cieco, controllato con placebo e comparatore attivo, per valutare l’efficacia e la sicurezza di diversi livelli di dosaggio di AZD5718 somministrato per via orale una volta al giorno per dodici settimane in adulti con asma non controllato da moderato a grave

A.3.1

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

Study to Assess the Efficacy and Safety of AZD5718 in Moderate-to-Severe Uncontrolled Asthma

Studio per valutare l’efficacia e la sicurezza di AZD5718 nell’asma non controllato da moderato a grave

A.3.2

Name or abbreviated title of the trial where available

FLASH

A.4.1

Sponsor's protocol code number

D7552C00001

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	Clinical Study Information Center
B.5.3	Address:
B.5.3.1	Street Address	NA
B.5.3.2	Town/ city	NA
B.5.3.3	Post code	NA
B.5.3.4	Country	United States
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.2.5	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	AZD5718
D.3.2	Product code	[AZD5718]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Non ancora disponibile
D.3.9.1	CAS number	2041075-86-7
D.3.9.2	Current sponsor code	AZD5718
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	125
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	Comparator
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	SINGULAIR
D.2.1.1.2	Name of the Marketing Authorisation holder	Organon Healthcare GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	SINGULAIR
D.3.2	Product code	[SINGULAIR]
D.3.4	Pharmaceutical form	Capsule
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	Montelukast
D.3.9.1	CAS number	158966-92-8
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	SINGULAIR
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	10
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	AZD5718
D.3.2	Product code	[AZD5718]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Non ancora disponibile
D.3.9.1	CAS number	2041075-86-7
D.3.9.2	Current sponsor code	AZD5718
D.3.9.3	Other descriptive name	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	25
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	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.3.8	INN - Proposed INN	SALBUTAMOLO
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: 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	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	AZD5718
D.3.2	Product code	[AZD5718]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Non ancora disponibile
D.3.9.1	CAS number	2041075-86-7
D.3.9.2	Current sponsor code	AZD5718
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	10
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	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
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

Asma non controllata da moderata a grave

Moderate-to-Severe Uncontrolled Asthma

E.1.1.1

Medical condition in easily understood language

Asthma (an illness that causes breathing difficulty) that is not fully controlled, so that episodes of breathing difficulty are still occurring despite the use of other available treatments

Asma (patologia che causa difficoltà respiratoria) non pienamente controllata, di conseguenza gli episodi di difficoltà respiratoria continuano ad avvenire nonostante l'uso di altri trattamenti

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	PT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma
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 clinical efficacy of AZD5718 as compared to placebo in adult participants with moderate-to-severe uncontrolled asthma

Valutare l’efficacia clinica di AZD5718 rispetto al placebo in partecipanti adulti con asma non controllato da moderato a grave

E.2.2

Secondary objectives of the trial

- Valutare l'efficacia clinica di AZD5718 a differenti livelli di dose in partecipanti adulti con asma non controllato da moderato a grave
- Valutare l'efficacia clinica di AZD5718 rispetto al placebo in partecipanti adulti con asma non controllato da moderato a grave. Per ulteriori obiettivi secondari si prega di fare riferimento al protocollo.

- To evaluate the clinical efficacy of AZD5718 at different dose levels in adult participants with
moderate-to-severe uncontrolled asthma
- To evaluate the clinical efficacy of AZD5718 as compared to placebo in adult participants with moderate-to-severe uncontrolled asthma. For further secondary objectives please refer to the protocol.

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: A PK/PD sub-study will be conducted in a sub-set of participants randomised in Part 1 and Part 2. As part of this sub-study, additional PK and PD blood samples will be collected

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Verrà condotto un sottostudio PK/PD in un sottogruppo di partecipanti randomizzati nella Parte 1 e nella Parte 2. Nell'ambito di questo sottostudio, verranno raccolti ulteriori campioni di sangue PK e PD

E.3

Principal inclusion criteria

Part 1 and Part 2
Specific Inclusion Criteria for Pre-Screening
1. Capable of giving signed informed consent.
2. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
3. Participant is willing and able to follow study procedures and restrictions.
4. Participant must be 18 to 80 years of age inclusive, at the time of signing the ICF.
5. Treated with low dose ICS-LABA or medium-high dose ICS alone or in combination with LABA at a stable dose for at least 3 months prior to
Visit 1.
- Treatment with additional asthma controller therapies (eg, LAMA) at a stable dose = 3 months prior to Visit 1 is allowed.
6. Documented history of >= 1 severe asthma exacerbation within 12
months prior to Visit 0.
7. Morning pre-BD FEV1 between >= 40% and <= 80% predicted at Visit 0.
8. Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria.
PLEASE REFER TO THE PROTOCOL FOR FURTHER INCLUSION CRITERIA

Parte 1 e Parte 2
Criteri di inclusione specifici per il pre-screening
1. Capacità di fornire un consenso informato firmato.
2. Fornitura del consenso informato scritto “Foglio informativo per la ricerca genetica facoltativa” firmato e datato prima della raccolta dei campioni per la ricerca genetica facoltativa supportata dall’Iniziativa genomica.
3. Il partecipante è disposto e in grado di seguire le procedure e le restrizioni dello studio.
4. Il partecipante deve avere un’età compresa tra 18 e 80 anni al momento della firma del modulo di consenso informato (ICF).
5. Trattato con corticosteroidi inalatori-ß2 agonisti a lunga durata d’azione (ICS-LABA) a basso dosaggio o ICS a dosaggio medio-alto da soli o in combinazione con LABA a una dose stabile per almeno 3 mesi prima della Visita 1.
- È consentito il trattamento con terapie di controllo dell’asma aggiuntive (ad es., LAMA) a una dose stabile >=3 mesi prima della Visita 1.
6. Anamnesi documentata di >=1 riacutizzazione grave dell’asma nei 12 mesi precedenti la Visita 0.
7. Volume espiratorio forzato in 1 secondo (FEV1) pre-broncodilatatore (pre-BD) al mattino tra >=40% e <=80% previsto alla Visita 0.
8. In grado di eseguire un test di funzionalità polmonare accettabile per FEV1 secondo i criteri di accettabilità della Società Toracica Americana e della Società Europea di Malattie Respiratorie (ATS/ERS) del 2019.
SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI CRITERI DI INCLUSIONE

E.4

Principal exclusion criteria

1. A severe asthma exacerbation within 8 weeks of randomisation.
2. A positive nucleic acid test (eg RT-PCR) at Visit 1 or at Visit 3 for
SARS-CoV-2, the virus responsible for COVID-19.
3. Participants with a significant COVID-19 illness within 6 months of
enrolment:
- Participants with a diagnosis of COVID-19 pneumonia based on
radiological assessment.
- Participants with a diagnosis of COVID-19 requiring hospitalisation
and/or oxygen supplementation therapy.
4. Clinically important pulmonary disease other than asthma eg, active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome
associated with obesity, lung cancer, history or planned lung lobectomy, alpha-1 anti-trypsin deficiency, primary ciliary dyskinesia, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis and hyper-eosinophilic syndrome.
5. Galactose intolerance, Lapp lactase deficiency, or glucose-galactose metabolism.
6. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
- Affect the safety of the participant throughout the study.
- Influence the findings of the study or the interpretation.
- Impede the participant's ability to complete the entire duration of the study
PLEASE REFER TO THE PROTOCOL FOR FURTHER EXCLUSION CRITERIA

1. Una riacutizzazione grave dell’asma entro 8 settimane dalla randomizzazione.
2. Un test positivo dell’acido nucleico (ad es., la reazione a catena della polimerasi a trascrizione inversa [RT-PCR]) alla Visita 1 o alla Visita 3 per SARS-CoV-2, il virus responsabile della COVID-19.
3. Partecipanti con una malattia significativa da COVID-19 entro 6 mesi dall’arruolamento:
- Partecipanti con diagnosi di polmonite da COVID-19 sulla base della valutazione radiologica.
- Partecipanti con diagnosi di COVID-19 che richiede ricovero e/o terapia con ossigeno supplementare.
4. Malattia polmonare clinicamente importante diversa dall’asma, ad es., infezione polmonare attiva, BPCO, bronchiectasia, fibrosi polmonare, fibrosi cistica, sindrome da ipoventilazione associata a obesità, carcinoma polmonare, lobectomia polmonare pregressa o programmata, deficit di alfa-1-antitripsina, discinesia ciliare primaria, sindrome di Churg-Strauss, aspergillosi broncopolmonare allergica e sindrome ipereosinofila.
5. Intolleranza al galattosio, deficit di Lapp lattasi o metabolismo del glucosio-galattosio.
6. Qualsiasi disturbo, tra cui, a titolo esemplificativo ma non esaustivo, compromissione cardiovascolare, gastrointestinale, epatica, renale, neurologica, muscoloscheletrica, infettiva, endocrina, metabolica, ematologica, psichiatrica o fisica maggiore che, a giudizio dello sperimentatore, non sia stabile e potrebbe:
- Influire sulla sicurezza del partecipante per tutta la durata dello studio.
- Influenzare i risultati dello studio o l’interpretazione.
- Impedire al partecipante di completare l’intera durata dello studio.
SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI CRITERI DI ESCLUSIONE

E.5 End points

E.5.1

Primary end point(s)

Time to first CompEx Asthma event

Tempo al primo evento di asma CompEx

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

Settimana 12

E.5.2

Secondary end point(s)

Clinical efficacy endpoints: change from baseline in:
1 pre-BD FEV1: Baseline, Week 4, and Week 12
2 SGRQ: Baseline, Week 4, and Week 12
Clinical efficacy endpoints: change from baseline in:
1 ACQ-6: Baseline, Week 4, Week 8, Week 12, and average over the 12- week treatment period
2 average morning and average evening PEF: Baseline, Week 4, Week 8, Week 12, and average over the 12-week treatment period
3 daily asthma symptom score (total, daytime, and night-time):
Baseline, Week 4, Week 8, Week 12, and average over the 12-week treatment period
Clinical efficacy endpoints:
1 time to first severe asthma exacerbation
2 event status (CompEx Asthma event yes/no)
To evaluate the PK of AZD5718:
1 AZD5718 plasma concentrations and PK parameters
2 AZD5718 plasma concentrations: post-dose samples taken at Week 4
3 AZD5718 plasma concentrations: pre-dose samples at Baseline, Week 4, and Week 12
Safety Endpoints:
Safety and tolerability evaluations using AEs, vital sign measures, clinical laboratory assessments, ECG and C-SSRS
Exploratory Endpoints:
- Change from baseline in:
1 Post BD FEV1: Baseline, and Week 12
2 Percent reversibility: Baseline and Week 12
3 Forced expiratory flow 25-75%: Baseline, Week 4, and Week 12
- Change from baseline in FeNO: Baseline, Week 4, and Week 12
- Change from baseline in cough VAS: Baseline, Week 4, and Week 12 and over the treatment period
- Change from baseline in:
1 site spirometry assessment: Baseline, Week 4 and Week 12
2 home spirometry assessment: Baseline, Week 4 and Week 12
- Change from baseline in:
1 time to first CompEx Asthma event
PLEASE REFER TO THE PROTOCOL FOR FURTHER DETAILS

Endpoints di efficacia clinica: variazione rispetto al basale di:
1 FEV1 pre-BD: basale, alla Settimana 4 e alla Settimana 12
2 SGRQ: basale, alla Settimana 4 e alla Settimana 12
Endpoints di efficacia clinica: variazione rispetto al basale di:
1 ACQ-6: basale, alla Settimana 4, alla Settimana 8,
alla Settimana 12 e media nel periodo di trattamento di 12 settimane
2 PEF mattutino medio e serale medio: basale, alla Settimana 4, alla Settimana 8, alla Settimana 12 e media nel periodo di trattamento di 12 settimane
3 punteggio giornaliero dei sintomi dell’asma (totale, diurno e notturno): basale, alla Settimana 4, alla Settimana 8, alla Settimana 12 e media nel periodo di trattamento di 12 settimane
Endpoints di efficacia clinica:
1 tempo alla prima riacutizzazione grave dell’asma
2 stato dell’evento (evento asmatico CompEx sì/no)
Valutazione della PK di AZD5718:
1 concentrazioni plasmatiche di AZD5718 e parametri PK
2 concentrazioni plasmatiche di AZD5718: campioni post-dose prelevati alla Settimana 4
3 concentrazioni plasmatiche di AZD5718: campioni pre-dose al basale, alla Settimana 4 e alla Settimana 12
Endpoints di sicurezza
Valutazioni di sicurezza e tollerabilità mediante AE, misure dei segni vitali, valutazioni cliniche di laboratorio, ECG e C-SSRS
Endpoint esplorativi:
- Modifica dalla linea di base in:
1 Post BD FEV1: basale e settimana 12
Reversibilità del 2%: basale e settimana 12
3 Flusso espiratorio forzato 25-75%: basale, settimana 4 e settimana 12
- Modifica rispetto al basale in FeNO: basale, settimana 4 e settimana 12
- Variazione rispetto al basale della VAS per la tosse: basale, settimana 4 e settimana 12 e durante il periodo di trattamento
- Modifica del basale in:
Valutazione spirometrica a 1 sito: basale, settimana 4 e settimana 12
2 Valutazione della spirometria domiciliare: basale, settimana 4 e settimana 12
- Modifica dalla linea di base in:
1 volta al primo evento CompEx Asthma
SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI DETTAGLI

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline, Week 4, Week 8 and Week 12

Basale, Settimana 4, Settimana 8 e Settimana 12

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

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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)

Yes

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

137

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

Japan

Korea, Republic of

South Africa

United States

France

Poland

Bulgaria

Netherlands

Romania

Spain

Czechia

Germany

Italy

Croatia

Hungary

Russian Federation

Slovakia

Slovenia

Ukraine

United Kingdom

Serbia

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

LSLV

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:

964

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

964

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

192

F.4.2

For a multinational trial

F.4.2.1

In the EEA

902

F.4.2.2

In the whole clinical trial

1928

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

2022-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-05-05

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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