Clinical Trials Register

Summary
EudraCT Number:	2011-001682-41
Sponsor's Protocol Code Number:	HLS03/2011
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:	2011-12-06
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-001682-41

A.3

Full title of the trial

Comparison of the efficacy and the safety of different schedules of administration of sub-lingual immunotherapy in patients with ragweed pollinosis: a phase III randomized and controlled clinical study.

Confronto dell`efficacia e della sicurezza di diversi schemi di somministrazione dell`immunoterapia sub-linguale in pazienti con pollinosi da ambrosia: studio clinico randomizzato controllato di fase III.

A.3.1

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

Comparison of efficacy and safety of different regimens of sublingual immunotherapy for Ragweed.

Confronto dell'efficacia e della sicurezza di diversi schemi di immunoterapia sublinguale per Ambrosia.

A.4.1

Sponsor's protocol code number

HLS03/2011

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	AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	ASIA Onlus
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	Ospedale Luigi Sacco
B.5.2	Functional name of contact point	S.S. Allergologia-Immunologia Clin.
B.5.3	Address:
B.5.3.1	Street Address	via G.B. Grassi 74
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20157
B.5.3.4	Country	Italy
B.5.4	Telephone number	02-39043490
B.5.5	Fax number	02-39042568
B.5.6	E-mail	iemoli.enrico@hsacco.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	Ragweed estract
D.3.4	Pharmaceutical form	Oral drops
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMBROSIA ARTEMISIIFOLIA L.
D.3.10	Strength
D.3.10.1	Concentration unit	SU Standardised Unit(s) (Deprecated)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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

Subjects who are allergic to Ragweed.

Soggetti allergici ad Ambrosia.

E.1.1.1

Medical condition in easily understood language

Ragweed allergic subjects.

Allergici ad 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	14.0
E.1.2	Level	SOC
E.1.2	Classification code	10021428
E.1.2	Term	Immune system disorders
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

Evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually vs oral-vestibular;
Assess the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually at a dose doubled 400 STU/dose vaccine compared to the commonly used marketing 200 STU/dose.

Valutare la percentuale di cellule CD14-PDL-1-IL10+ circolanti allergene-specifiche in pazienti allergici all'ambrosia sottoposti a ciclo pre-costagionale di SLIT somministrata per via sublinguale vs orale-vestibolare;
Valutare la percentuale di cellule CD14-PDL-1-IL10+ circolanti allergene-specifiche in pazienti allergici all'ambrosia sottoposti a ciclo pre-costagionale di SLIT somministrata per via sublinguale a una dose raddoppiata 400 STU/dose rispetto al vaccino comunemente in uso in commercio 200 STU/dose.

E.2.2

Secondary objectives of the trial

Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine by vestibular compared to those treated sublingually;
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose;
Evaluation of the safety and tolerability (as assessed by data collection form of local and systemic adverse events) among patients treated with sublingual vaccine in oral/vestibular administration compared to those treated sublingually;
Assessment of safety and tolerability (assessed using data forms of local and systemic adverse events) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose.

Valutazione della efficacia clinica nel gruppo di pazienti trattati con vaccino sublinguale per via vestibolare rispetto a quelli trattati per via sublinguale.
Valutazione dell'efficacia clinica nel gruppo di pazienti trattati con vaccino sublinguale a dosaggio doppio rispetto a quelli con dosaggio standard.
Valutazione della sicurezza e della tollerabilità nel gruppo di pazienti trattati con vaccino sublinguale per via vestibolare rispetto a quelli trattati per via sublinguale.
Valutazione della sicurezza e della tollerabilità nel gruppo di pazienti trattati con vaccino sublinguale a dosaggio raddoppiato rispetto a quelli trattati con dosaggio standard.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Adults aged 18-55 years, known allergy to ragweed pollen, no immunotherapy or in progress prior to enrollement, symptoms of rhino/conjunctivitis with or without asthma.

Adulti di età compresa tra i 18 e i 55 anni, allergia accertata all'Ambrosia, nessuna immunoterapia in corso o precedente l'arruolamento, sintomi di rino-congiuntivite con o senza asma.

E.4

Principal exclusion criteria

Allergic to perennial allergens (moulds, mites and animal when exposed to the animal), patients with chronic diseases (infectious, autoimmune cancer, heart or kidney), pregnancy, chronic drug treatment with steroids and/or immunosuppressive drugs, oral diseases.

Pazienti allergici ad allergeni perenni, pazienti affetti da malattie croniche, gravidanza in atto, trattamenti farmacologici cronici con steroidi o immunosoppressori, malattie del cavo orale.

E.5 End points

E.5.1

Primary end point(s)

The end of the study will detect a difference between groups with respect to the primary objective, the percentage of CD14-PDL-1-IL10 + outstanding of at least 25 percentile points.

Alla fine dello studio si rileverà una differenza tra i gruppi di percentuale di cellule CD14-PDL-1-IL10+ circolanti pari almeno a 25 punti percentili.

E.5.1.1

Timepoint(s) of evaluation of this end point

At study termination (3 months).

Al termine dello studio (3 mesi).

E.5.2

Secondary end point(s)

None.

Nessuno.

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable.

Non applicabile.

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

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

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

altra via di somministrazione. - Stesso farmaco ad altro dosaggio

other mode of administration. - 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

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

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

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

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:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-06.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

Yes

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

F.4.2.2

In the whole clinical trial

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)

Subjects will continue the treatment of their Ragweed allergy according to the best clinical standard.

Proseguiranno il trattamento dell'allergia ad Ambrosia secondo il miglior standard clinico.

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

2011-05-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-06

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