Clinical Trials Register

Summary
EudraCT Number:	2016-004941-94
Sponsor's Protocol Code Number:	ARC004
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-05
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-004941-94

A.3

Full title of the trial

PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (PALISADE) FOLLOW-ON STUDY

Studio di Follow-on sull¿Immunoterapia orale per l¿allergia alle arachidi, Studio su AR101 per la desensibilizzazione in bambini e adulti (PALISADE)

A.3.1

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

PEANUT ALLERGY STUDY

Studio sull'allergia alle arachidi

A.3.2

Name or abbreviated title of the trial where available

PALISADE

A.4.1

Sponsor's protocol code number

ARC004

A.5.4

Other Identifiers

Name:

Number:

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/275/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AIMMUNE THERAPEUTICS
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Aimmune Therapeutics, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Aimmune Therapeutics UK Ltd
B.5.2	Functional name of contact point	Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	10 Eastbourne Terrace
B.5.3.2	Town/ city	Londra
B.5.3.3	Post code	W2 6LG
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00442039232530
B.5.5	Fax number	00442072625642
B.5.6	E-mail	dvandenberghe@aimmune.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	AR101
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Granules
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	AR101
D.3.9.2	Current sponsor code	AR101
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	300
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)	Yes
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	AR101
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Modified-release granules
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	AR101
D.3.9.2	Current sponsor code	AR101
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	0
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)	Yes
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	AR101
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Modified-release granules
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	AR101
D.3.9.2	Current sponsor code	AR101
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	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)	Yes
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	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	AR101
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Modified-release granules
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	AR101
D.3.9.2	Current sponsor code	AR101
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	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)	Yes
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	AR101
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Modified-release granules
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	AR101
D.3.9.2	Current sponsor code	AR101
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	20
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)	Yes
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	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	AR101
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Modified-release granules
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	AR101
D.3.9.2	Current sponsor code	AR101
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	100
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)	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Peanut Allergy

Allergia alle arachidi

E.1.1.1

Medical condition in easily understood language

Allergy to peanuts or peanut-containing foods

Allergia alle arachidi o a cibi contenenti arachidi

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10013289
E.1.2	Term	Disorders involving the immune mechanism
E.1.2	System Organ Class	100000004870

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to determine the safety, tolerability and efficacy of AR101 characterized oral desensitization immunotherapy using alternative maintenance dosing intervals.

L¿obiettivo primario di questo studio ¿ determinare la sicurezza, la tollerabilit¿ e l¿efficacia di AR101 immunoterapia orale caratterizzata per la desensibilizzazione utilizzando intervalli di dosaggio di mantenimento alternativi.

E.2.2

Secondary objectives of the trial

The secondary objectives are:
¿ To confirm the safety profile of AR101 as measured by the incidence of adverse events (AEs), including serious adverse events (SAEs)
¿ To confirm the efficacy of AR101 through reduction in clinical reactivity, measured in a double-blind, placebo-controlled food challenge
(DBPCFC) to a cumulative dose of 4043 mg
¿ To evaluate subjects' quality of life (QoL) and treatment satisfaction during AR101 treatment on daily and non-daily treatment regimens
¿ To evaluate the long-term immunologic effects of AR101 treatment

Gli obiettivi secondari sono:
¿ Confermare il profilo di sicurezza di AR101 come misurato tramite l¿incidenza degli eventi avversi (AE), compresi gli eventi avversi gravi (SAE)
¿ Confermare l¿efficacia di AR101 attraverso la riduzione della reattivit¿ clinica, misurata in un test di provocazione alimentare in doppio cieco controllato verso placebo (double blind placebo controlled food challenge, DBPCFC) per una dose cumulativa di 4.043 mg
¿ Valutare la qualit¿ della vita (QoL) dei soggetti e la soddisfazione del trattamento durante il trattamento con AR101 nei regimi di trattamento giornaliero e non giornaliero
¿ Valutare gli effetti immunologici a lungo termine del trattamento con AR101

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: Exploratory Biochemical and Molecular Substudy of Peanut-Allergic Children and Adults with Oral Immunotherapy-Related Gastrointestinal Symptoms in Study ARC004.
Primary Objective:
The primary objective is to analyze biomolecular expression patterns in saliva samples obtained longitudinally from peanut-allergic participants undergoing OIT in ARC004. These studies will target the salivary RNA transcriptome, and if necessary further validate, with molecular-, cellular-, and/or protein-based approaches, the expression profile of gene pathways that are likely relevant to intolerable GI side effects in ARC004 subjects.
Secondary Objectives:
The key secondary objective is to examine the relationship of the RNA expression profile to selected clinical variables from ARC004, including:
¿ The frequency and severity of AEs related to the gastrointestinal tract
¿ The frequency of dosing interruptions (reductions and/or discontinuations) directly related to GI AEs
¿ Peripheral blood eosinophil counts
¿ PEESS v2.0 scores
¿ Immunoglobulin levels (IgE, IgG4, and their subclasses).
Further secondary objectives include the correlation of salivary RNA transcriptome data to histopathologic and molecular analyses of the esophagus, when available.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio biochimico e molecolare esplorativo su bambini ed adulti con allergia alle arachidi e con sintomi gastrointestinali correlati all'Immunoterapia nello studio ARC004.
Obiettivo Primario:
Analizzare I pattern di espressione biomolecolare nei campioni di saliva ottenuti longitudinalmente dai partecipanti allergici alle arachidi in trattamento di immunoterapia orale in ARC004. Questi studi si incentreranno sugli RNA salivari trascritti, e se necessario valideranno, con approcci molecolari, cellulari e proteici, il profilo di espressione dei pathway genetici relativi ad effetti collaterali gastrointestinali intollerabili nei soggetti ARC004.
Obiettivi secondari:
L'obiettivo secondario chiave ¿ esaminare la relazione tra il profilo di espressione dell'RNA e le variabili cliniche selezionate da ARC004, comprese:
¿ La frequenza e la gravit¿ degli eventi avversi relative al tratto gastrointesinale
¿ La frequenza di interruzione di dose (riduzione e/o interruzione) direttamente correlata agli eventi avversi gastrointestinali
¿ Conta degli eosinofili nel sangue periferico
¿ livelli di Immunoglobuline (IgE, IgG4 e sottoclassi).
Ulteriori obiettivi secondary includono la correlazione dei dati sui trascritti salivari di RNA con analisi istopatologiche e molecolari dell'esofago, se disponibili.

E.3

Principal inclusion criteria

1. Completion of ARC003
2. Written informed consent and/or assent from subjects/guardians as appropriate
3. Use of effective birth control by female subjects of child-bearing potential

1. Completamento di ARC003
2. Consenso informato scritto e/o assenso da soggetti/tutori secondo necessità
3. Uso di metodi di contraccezione efficaci da parte dei soggetti di sesso femminile in età fertile

E.4

Principal exclusion criteria

1. Early discontinuation from ARC003
2. Meets any longitudinally applicable ARC003 exclusion criteria
3. Failure to tolerate =443 mg cumulative of peanut protein with no or
mild symptoms in the ARC003 Exit DBPCFC (Group 2 only)
4. Any other condition that, in the opinion of the Investigator, precludes
participation for reasons of safety

1. Interruzione anticipata di ARC003
2. Risponde a tutti i criteri di esclusione da ARC003 longitudinalmente applicabili (Appendice 7)
3. (Solo per il Gruppo 2) Incapacità di tollerare ¿443 mg cumulativi di proteina di arachide con sintomi lievi o assenti al DBPCFC di uscita di ARC003
4. Qualsiasi altra condizione che, a giudizio dello sperimentatore, preclude la partecipazione per motivi di sicurezza

E.5 End points

E.5.1

Primary end point(s)

The primary end-point is the frequency of treatment-related adverse events, including serious adverse events, during the overall study period (from enrollment to the end of Extended Maintenance).

L'end-point primario è la frequenza degli eventi avversi relativi al trattamento, compresi gli eventi
avversi seri, durante tutto il periodo dello studio (dall'arruolamento alla fine del mantenimento prolungato).

E.5.1.1

Timepoint(s) of evaluation of this end point

The overall study period (from enrolment to the end of the Extended Maintenance Period)

Il periodo totale dello studio (dall'arruolamento alla fine del periodo di Mantenimento Prolungato)

E.5.2

Secondary end point(s)

Secondary endpoints include:
¿ Frequency of anaphylaxis
¿ Frequency of use of epinephrine as a rescue medication
¿ Frequency of AEs leading to withdrawal of AR101
¿ Frequency of AEs in each treatment regimen leading to discontinuation
of extended interval dosing
¿ Frequency of gastrointestinal adverse events of interest (GI AEIs)
¿ Frequency of accidental food allergen exposure
¿ In subjects with asthma, change in asthma control using the Asthma
Control Test questionnaire
¿ Frequency of all above safety endpoints by treatment period
¿ The proportion of subjects in each regimen tolerating = 1043 mg
cumulative of peanut protein during their EM Exit DBPCFC
¿ The proportion of subjects in each regimen who tolerate = 443 mg
cumulative of peanut protein during their EM Exit DBPCFC
¿ The proportion of subjects in each regimen who tolerate 4043 mg
cumulative of peanut protein during their EM Exit DBPCFC
¿ Maximum tolerated dose and change from baseline at Post-Maintenance and each EM Exit DBPCFC
¿ Maximum severity of symptoms at each challenge dose at Post-Maintenance and each EM Exit DBPCFC
¿ Frequency of use of epinephrine as a rescue medication at the Post-Maintenance and each EM Exit DBPCFC
¿ Change in QoL as assessed by the food allergy related quality of life questionnaire (FAQLQ) and the food allergy independent measure (FAIM) questionnaire
¿ Satisfaction with AR101 treatment as assessed by the Treatment Satisfaction Questionnaire for Medication Version 9 (TSMQ-9) questionnaire and additional questions
¿ Changes in peanut-specific serum IgE and IgG4 levels
¿ Changes in peanut skin prick test (SPT) wheal diameter

Gli endpoint secondari includono:
¿ Frequenza di anafilassi
¿ Frequenza d¿uso di epinefrina come farmaco di soccorso
¿ Frequenza di AE che conducono all¿interruzione di AR101
¿ Frequenza di AE in ogni regime di trattamento che conducono alla sospensione dell¿intervallo di dosaggio esteso
¿ Frequenza di GI AE di interesse (GI AEI)
¿ Frequenza di esposizioni accidentali ad allergeni alimentari
¿ Nei soggetti con asma, variazioni nel controllo dell¿asma utilizzando il questionario Test di controllo dell¿asma
¿ Frequenza di tutti gli endpoint di sicurezza di cui sopra per periodo di trattamento
¿ La proporzione di soggetti in ogni regime che tollera = 1.043 mg cumulativi di proteina di arachide durante la loro DBPCFC di uscita dell¿EM
¿ La proporzione di soggetti in ogni regime che tollera = 443 mg cumulativi di proteina di arachide durante la loro DBPCFC di uscita dell¿EM
¿ La proporzione di soggetti in ogni regime che tollera 4.043 mg cumulativi di proteina di arachide durante la loro DBPCFC di uscita dell¿EM
¿ Dose massima tollerata e cambiamento dal basale al post-mantenimento e a ogni DBPCFC di uscita dell¿EM
¿ Massima gravit¿ dei sintomi a ogni dose challenge nel post-mantenimento e a ogni DBPCFC di uscita dell¿EM
¿ Frequenza d¿uso di epinefrina come farmaco di soccorso nel post-mantenimento e a ogni DBPCFC di uscita dell¿EM
¿ Cambiamento nella QoL come valutato tramite il Questionario sulla qualit¿ della vita correlata all¿allergia alimentare (FAQLQ) e il Questionario di misura indipendente dell¿allergia alimentare (FAIM)
¿ Soddisfazione per il trattamento con AR101 come valutato tramite il Questionario sulla soddisfazione del trattamento per la versione del farmaco 9 (TSMQ-9) e ulteriori domande
¿ Cambiamenti nei livelli di IgE e IgG4 arachide-specifici nel siero
¿ Cambiamenti nel diametro del pomfo da prick test cutaneo (SPT) per l¿arachide

E.5.2.1

Timepoint(s) of evaluation of this end point

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

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

United States

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

250

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

150

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

100

F.1.3

Elderly (>=65 years)

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

150

F.4.2.2

In the whole clinical trial

500

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Nessuno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-07-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-23

P. End of Trial
P.	End of Trial Status	Completed

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:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials