| 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 | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
The primary objective is to demonstrate the
efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children and adolescents (ages 4 to 17 years, inclusive). |
| L'obiettivo primario è dimostrare l'efficacia di AR101, una formulazione di allergene dell'arachide di grado farmaceutico, attraverso la riduzione nella reattività clinica a quantità limitate di allergene dell'arachide in bambini e adolescenti allergici alle arachidi (età compresa tra 4 e 17 anni inclusi). |
|
| E.2.2 | Secondary objectives of the trial |
• To demonstrate the safety of AR101 as measured by the incidence of adverse events (AEs), including serious adverse events (SAEs).
• To evaluate the immunological effects of peanut OIT therapy. |
• Dimostrare la sicurezza di AR101 misurata tramite l'incidenza degli eventi avversi (AE), compresi gli eventi avversi seri (SAE).
• Valutare gli effetti immunologici della terapia OIT per l'allergia alle arachidi. |
|
| 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 |
| The purpose of the sub-study is to store blood samples for possible future studies to look at markers in their blood that show how the immune system responds to a food allergy. |
| Lo scopo del sottostudio è conservare campioni di sangue per eventuali studi futuri, al fine di esaminare i marcatori nel sangue che indichino come il sistema immunitario risponde all’allergia alimentare. |
|
| E.3 | Principal inclusion criteria |
• Age 4 through 17 years (inclusive)
• Clinical history of allergy to peanuts or peanut-containing foods
• Serum IgE to peanut ≥ 0.35 kUA/L, inclusive (as determined by UniCAP™ within the past 12 months) and/or a peanut SPT wheal diameter ≥ 3 mm compared to control
• Experience DLS at or before the 300 mg (444 mg cumulative) challenge dose of peanut protein (measured as 600 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) guidelines
• Written informed consent from subject or parent/guardian for all subjects
• Written assent from minor subjects as appropriate (eg, above the age of 7 years or the applicable age per local regulatory requirements)
• Use of effective birth control by female subjects of child-bearing potential |
• Età compresa fra 4 e 17 anni (inclusi)
• Anamnesi clinica di allergia alle arachidi o ad alimenti contenenti arachidi.
• IgE sieriche per le arachidi 0,35 kUA/l, per tutti (in base a quanto stabilito da UniCAP™ entro gli ultimi 12 mesi) e/o diametro del ponfo da SPT per le arachidi ≥ 3 mm rispetto al controllo.
• Manifestazione di DLS in occasione o prima della dose challenge di 300 mg (dose cumulativa di 444 mg) di proteina di arachidi (pari a 600 mg di farina di arachidi) al DBPCFC di screening condotto in conformità con le linee guida PRACTALL
(Practical Issues in Allergology, Joint United States/European Union Initiative).
• Consenso informato scritto del soggetto o genitore/tutore per tutti i soggetti.
• Assenso scritto dei soggetti minori, ove richiesto (per esempio, nel caso di età superiore a 7 anni o in base all’età prevista dai requisiti normativi locali).
• Uso di metodi di contraccezione efficaci da parte dei soggetti di sesso femminile potenzialmente fertili |
|
| E.4 | Principal exclusion criteria |
• History of hemodynamically significant cardiovascular disease, including uncontrolled or inadequately controlled hypertension
• History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC
• History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of, becoming unstable or requiring a
change in chronic therapeutic regimen
• History of eosinophilic esophagitis (EoE), other eosinophilic GI disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
symptoms of dysphagia (eg, difficulty swallowing, food “getting stuck”), or recurrent GI symptoms of undiagnosed etiology
• Current participation in any other interventional study and/or participation in another interventional clinical study within 30 days or 5 half-lives of the IP,
whichever is longer, prior to randomization
• Participation in, and having received active treatment in, any previous clinical study of AR101 CODIT™
• Participation in any peanut immunotherapy clinical study (including oral, sublingual, or epicutaneous) within 6 months prior to Screening
• Subject is in “build-up phase” of immunotherapy |
• Anamnesi di malattia cardiovascolare emodinamicamente significativa, compresa
ipertensione incontrollata o controllata in modo inadeguato.
• Anamnesi di episodi di anafilassi o shock anafilattico gravi o pericolosi per la vita entro 60 giorni dal DBPCFC di screening.
• Anamnesi di malattia cronica (diversa da asma, dermatite atopica o rinite allergica) che evolve o è significativamente a rischio di evolvere verso
l'instabilità, o che richiede un cambiamento di regime terapeutico cronico.
• Anamnesi di esofagite eosinofila (EoE), altre malattie GI eosinofile, reflusso gastroesofageo (GERD) cronico ricorrente o grave, sintomi di disfagia (ad esempio difficoltà di deglutizione, cibo "conficcato") o altri sintomi ricorrenti di GI di eziologia non diagnosticata.
• Partecipazione contemporanea a qualsiasi altro studio interventistico e/o partecipazione a un altro studio clinico interventistico entro 30 giorni o 5 emivite dell'IP, a seconda del periodo più lungo, prima della randomizzazione.
• Partecipazione a, e assunzione di un trattamento attivo per qualsiasi studio clinico precedente condotto su AR101 CODIT™.
• Partecipazione a qualsiasi studio clinico condotto su un'immunoterapia per l'arachide (orale, sublinguale o epicutanea) entro i 6 mesi precedenti lo screening.
• Soggetto in "fase di accumulo" di immunoterapia per un altro allergene (vale a dire che non ha raggiunto il dosaggio di mantenimento). |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary clinical efficacy endpoint is the
proportion of subjects who tolerate at least
2043 mg cumulative of peanut protein with no more than mild symptoms at the Exit DBPCFC. |
L'endpoint primario di efficacia clinica è costituito dalla proporzione di soggetti che tollerano almeno
una dose cumulativa di 2043 mg di proteina di arachidi con sintomi non più che lievi al DBPCFC di uscita. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| After approximately 52 weeks of treatment. |
| Dopo circa 52 settimane di trattamento. |
|
| E.5.2 | Secondary end point(s) |
• The proportion of subjects who tolerate at least 1043 mg cumulative of peanut protein with no more than mild symptoms at the Exit DBPCFC
• The proportion of subjects who tolerate at least 443 mg cumulative of peanut protein with no more than mild symptoms at the Exit DBPCFC
• The maximum severity of symptoms occurring following ingestion of peanut protein during the Exit DBPCFC. |
• Proporzione di soggetti che tollerano almeno una dose cumulativa di 1043 mg di proteina di arachidi con sintomi non più che lievi al DBPCFC di uscita.
• Proporzione di soggetti che tollerano almeno una dose cumulativa di 443 mg di proteina di arachidi con sintomi non più che lievi al DBPCFC di uscita.
• Gravità massima dei sintomi che si verificano in seguito all'ingestione di proteina di arachidi al DBPCFC di uscita. |
|
| 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 | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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 | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 17 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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