Clinical Trials Register

Summary
EudraCT Number:	2011-004522-10
Sponsor's Protocol Code Number:	Lais-Amb-11
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:	2012-03-02
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-004522-10

A.3

Full title of the trial

Study on the efficacy and safety of three different doses of Lais Ambrosia tablets in patients with allergic rhinoconjunctivitis to pollen of Ambrosia

Studio sull'efficacia e la sicurezza di tre diversi dosaggi di Lais Ambrosia compresse in pazienti con rinocongiuntivite allergica al polline di Ambrosia

A.3.1

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

Study on the efficacy and safety of three different doses of Lais Ambrosia tablets in patients with allergy to pollen of Ambrosia

Studio sull’efficacia e la sicurezza di tre diversi dosaggi di Lais Ambrosia compresse in pazienti allergici al polline di Ambrosia

A.3.2

Name or abbreviated title of the trial where available

Sublingual immunotherapy with Lais Ambrosia Tablets

Immunoterapia Sublinguale con Lais Ambrosia cpr.

A.4.1

Sponsor's protocol code number

Lais-Amb-11

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	LOFARMA
B.1.3.4	Country	Italy
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	LOFARMA S.P.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LOFARMA S.p.A.
B.5.2	Functional name of contact point	Dr. M. Bruno - MEDICAL DEPARTMENT
B.5.3	Address:
B.5.3.1	Street Address	Viale Cassala, 40
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20143
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 58198211
B.5.5	Fax number	+39 02 8322512
B.5.6	E-mail	marco.bruno@lofarma.it

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	Lais Ambrosia tablets 300 UA
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Orodispersible tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMBROSIA ARTEMISIIFOLIA L.
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	monomeric allergoid from ragweed pollen extract
D.3.9.4	EV Substance Code	SUB29896
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Lais Ambrosia tablets 1000 UA
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Orodispersible tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMBROSIA ARTEMISIIFOLIA L.
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	monomeric allergoid from ragweed pollen extract
D.3.9.4	EV Substance Code	SUB29896
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Lais Ambrosia tablets 2000 UA
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Orodispersible tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMBROSIA ARTEMISIIFOLIA L.
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	monomeric allergoid from ragweed pollen extract
D.3.9.4	EV Substance Code	SUB29896
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2000
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

rhinoconjunctivitis allergic to ragweed pollen

rinocongiuntivite allergica al polline di ambrosia

E.1.1.1

Medical condition in easily understood language

Allergy to ragweed pollen

Allergia al polline di ambrosia

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10054928
E.1.2	Term	Allergy to plants
E.1.2	System Organ Class	10021428 - Immune system 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 assess the efficacy and safety of treatment with sublingual specific immunotherapy (antiallergic vaccination) with allergoid monomeric ragweed (Ambrosia LAIS) in three different doses in patients with rhinoconjunctivitis to ragweed pollen

valutazione dell’efficacia e della sicurezza di un trattamento di immunoterapia specifica (vaccino antiallergico)sublinguale con allergoide monomerico di ambrosia (LAIS Ambrosia) in tre diversi dosaggi in pazienti affetti da rinocongiuntivite allergica da polline di ambrosia.

E.2.2

Secondary objectives of the trial

to document the safety of treatment with LAIS Ambrosia (incidence of adverse events)

documentare la sicurezza del trattamento con i LAIS Ambrosia compresse(incidenza di eventi avversi)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Signed Informed Consent -Male or female patients aged between 18 and 75 years with a documented history of at least two years of rhinitis and / or moderate to severe allergic rhinoconjunctivitis to ragweed pollen seasonal allergic asthma with or without controlled. -clinically relevant sensitization to ragweed pollen -Positive clinical history to ragweed pollen -Availability to attend the study visits requested by the protocol during the study participation -Negative Pregnancy Urinary test (if female in fertile age) -If woman is of fertile age, she has been using a highly efficacious method of birth control for at least one month before the study enrolment and agrees to continue the use for the entire duration of the study. -Capable to fully understand the protocol and be compliant to the instructions reported in the protocol itself. -Positive response to the TPN test.

- Consenso informato firmato e datato. - Maschi e femmine di età fra 18 e 75 anni con una storia documentata di almeno due anni di rinite e/o rinocongiuntivite allergica moderata-grave da polline di ambrosia con o senza asma allergica stagionale controllata. - Sensibilizzazione clinicamente rilevante a polline di ambrosia. - Storia clinica positiva per polline di ambrosia. - Disponibilità a presentarsi alle visite previste dal protocollo per tutta la durata dello studio. - Test urinario di gravidanza negativo (se donne in età fertile). - Se donne in età fertile, che stiano utilizzando un metodo altamente efficace di controllo delle nascite, da almeno un mese prima dell’arruolamento e che acconsentano a continuare ad utilizzarlo per tutta la durata dello studio. - In grado di comprendere pienamente il protocollo e di aderire alle istruzioni in esso presenti. - Risposta positiva al test di provocazione nasale TPN.

E.4

Principal exclusion criteria

- Concomitant participation in other interventional clinical trials - Previous immunotherapy with ragweed allergen in the last 3 years. - Ongoing immunotherapy. - clinically relevant sensitization to other stagional aereous allergens such as Cupressacee, Graminacee, Parietaria, Artemisia, Betulacee, and/or to perennial allergens like house dust mites, cats and dogs dander. - Patients being in any relationship or dependence with the sponsor and/or investigator - Other reasons contra-indicating an inclusion into the trial according to the investigator’s estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions) - Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection - Predominant perennial allergic rhinitis - Partly controlled or uncontrolled asthma - Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value - Galactose-intolerance or malabsorption syndrome - Active tuberculosis - Generally inflammatory as well severe acute and chronic inflammatory diseases - Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis) - Immune deficiency (for example induced by immunosuppressive drugs) - Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism - Malignancy - Alcohol abuse.

- Partecipazione contemporanea ad altri studi clinici interventistici. - Precedente immunoterapia con allergeni di ambrosia negli ultimi 3 anni. - Immunoterapia specifica in corso. - Sensibilizzazione clinicamente rilevante ad altri allergeni aerei stagionali quali Cupressacee, Graminacee, Parietaria, Artemisia, Betulacee, e/o perenni quali cane, gatto (se in casa) o acari. - Pazienti con qualunque rapporto o dipendenza dallo sponsor e/o dallo Sperimentatore. - Altre ragioni che sconsiglino l’inclusione nello studio clinico secondo la valutazione dello Sperimentatore (ad esempio, scarsa compliance, incapacità del paziente di comprendere i documenti e le istruzioni di studio). - Gravidanza in essere o prevista, allattamento e/o mancanza di protezione contraccettiva adeguata. - Rinite allergica perenne predominante. - Asma parzialmente controllata o incontrollata. - Asma cronica o enfisema, in particolare con un FEV < 70% del valore previsto misurato tramite spirometria. - Intolleranza al lattosio o sindrome da malassorbimento. - Tubercolosi attiva. - Malattie infiammatorie generali, nonché malattie infiammatorie gravi acute e croniche. - Disordini secondari irreversibili all’organo bersaglio (enfisema, bronchiectasia). - Immunodeficienza (ad esempio indotta da farmaci immunosoppressivi). - Malattie diagnosticate da un medico ai reni, alla milza, al sistema nervoso, nonché malattie reumatiche basate su un meccanismo autoimmune. - Tumore maligno. - Abuso di alcol. - Controindicazioni per l’uso di adrenalina (ad esempio malattia coronaria sintomatica acuta o cronica, ipertensione grave, ipertiroidismo). - Trattamento in corso o pregresso con anticorpi anti-IgE. - Sinusite cronica o rinite medicamentosa. - Allergia all’Artemisia (IgE specifiche per Artemisia vulgaris >2,5 kU/L dosate con metodo enzimatico (CAP-test).

E.5 End points

E.5.1

Primary end point(s)

The efficacy of immunotherapy with sublingual tablets allergoid LAIS Ambrosia will be assessed through the measurement of individual variation in specific nasal provocation test (NPT) performed with Ambrosia Allerkin

L’efficacia dell’immunoterapia sublinguale con compresse di allergoide LAIS Ambrosia verrà valutata attraverso la misura della variazione individuale al test di provocazione nasale specifico (TPN) effettuato con Ambrosia Allerkin Test

E.5.1.1

Timepoint(s) of evaluation of this end point

- basal assesment before the randomization (same day of the first IMP administration)

- Rilevazione basale prima della randomizzazione (stesso giorno dell'assunzione della prima compressa); - Rilevazione finale a fine trattamento, ovvero dopo 120 +/- 7gg

E.5.2

Secondary end point(s)

Incidence of Adverse Events

Incidenza degli eventi avversi

E.5.2.1

Timepoint(s) of evaluation of this end point

Randomizzation visit (basal, pre-treatment),V2 after 30 +/- 2 dd since V1, V3 after 90 +/- 7 dd since V1 and V4 after 120 +/- 7 dd since V1.

Visita di randomizzazione (basale, pre-trattamento),V2 dopo 30 +/- 2gg da V1, V3 dopo 90 +/- 7gg da V1 e V4 dopo 120 +/- 7gg da V1.

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

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

- Stesso farmaco ad altro dosaggio

- same IMP used at different dosage

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

105

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)

The subjects will stop the study treatment at the end of their participation to the clinical trial and they will go on to take the current therapy or a different specific immunotherapy with exclusion of any changes that the Investigator Physician will consider necessary to guarantee a better control of the symptoms

Il trattamento in studio sarà sospeso al termine della partecipazione dei soggetti alla spermentazione e questi continueranno con la terapia già in atto o con una diversa forma di vaccinoterapia, fatte salve eventuali variazioni che il Medico Responsabile della Sperimentazione riterrà utili per garantire il miglior controllo dei sintomi.

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

2012-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-14

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

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