Clinical Trials Register

Summary
EudraCT Number:	2014-005471-88
Sponsor's Protocol Code Number:	MG56-SIT-012
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-09-04
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

Spain - AEMPS

A.2

EudraCT number

2014-005471-88

A.3

Full title of the trial

Double blind, placebo-controlled, dose finding, prospective, multicenter clinical trial for the treatment of rhinitis/rinoconjuntivitis against grass pollen allergy

Ensayo clínico prospectivo multicéntrico aleatorizado de doble simulación controlado con placebo de búsqueda de la dosis más eficaz para el tratamiento de rinitis/rinoconjuntivitis por alergia frente al polen de Gramíneas

A.3.1

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

Double blind, placebo-controlled, dose finding, prospective, multicenter clinical trial for the treatment of rhinitis/rinoconjuntivitis against grass pollen allergy

A.4.1

Sponsor's protocol code number

MG56-SIT-012

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	INMUNOTEK, S.L.
B.1.3.4	Country	Spain
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	INMUNOTEK, S.L.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	INMUNOTEK, S.L.
B.5.2	Functional name of contact point	Miguel Casanovas
B.5.3	Address:
B.5.3.1	Street Address	Punto Mobi, 5
B.5.3.2	Town/ city	Alcalá de Henares
B.5.3.3	Post code	28805
B.5.3.4	Country	Spain
B.5.4	Telephone number	34912908942110
B.5.5	Fax number	34916639732
B.5.6	E-mail	mcasanovas@inmunotek.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	MG56-I
D.3.2	Product code	MG56-I
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	POLLEN ALLERGEN EXTRACTS
D.3.9.4	EV Substance Code	SUB130721
D.3.10	Strength
D.3.10.1	Concentration unit	BAU/ml Bioequivalent Allergy Unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000 to 50000
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	MG56-II
D.3.2	Product code	MG56-II
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	POLLEN ALLERGEN EXTRACTS
D.3.9.4	EV Substance Code	SUB130721
D.3.10	Strength
D.3.10.1	Concentration unit	BAU/ml Bioequivalent Allergy Unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000 to 500000
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	MG56-III
D.3.2	Product code	MG56-III
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	POLLEN ALLERGEN EXTRACTS
D.3.9.4	EV Substance Code	SUB130721
D.3.10	Strength
D.3.10.1	Concentration unit	BAU/ml Bioequivalent Allergy Unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000 to 50000
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: 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	MG56-IV
D.3.2	Product code	MG56-IV
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	POLLEN ALLERGEN EXTRACTS
D.3.9.4	EV Substance Code	SUB130721
D.3.10	Strength
D.3.10.1	Concentration unit	BAU/ml Bioequivalent Allergy Unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000 to 50000
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: 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	MG56-V
D.3.2	Product code	MG56-V
D.3.4	Pharmaceutical form	Sublingual spray, solution
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	N/A
D.3.9.3	Other descriptive name	POLLEN ALLERGEN EXTRACTS
D.3.9.4	EV Substance Code	SUB130721
D.3.10	Strength
D.3.10.1	Concentration unit	BAU/ml Bioequivalent Allergy Unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000 to 50000
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: 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	MG56-VI
D.3.2	Product code	MG56-VI
D.3.4	Pharmaceutical form	Sublingual spray, solution
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	N/A
D.3.9.3	Other descriptive name	POLLEN ALLERGEN EXTRACTS
D.3.9.4	EV Substance Code	SUB130721
D.3.10	Strength
D.3.10.1	Concentration unit	BAU/ml Bioequivalent Allergy Unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000 to 50000
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: 7
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	MG56-VII
D.3.2	Product code	MG56-VII
D.3.4	Pharmaceutical form	Sublingual spray, solution
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	N/A
D.3.9.3	Other descriptive name	POLLEN ALLERGEN EXTRACTS
D.3.9.4	EV Substance Code	SUB130721
D.3.10	Strength
D.3.10.1	Concentration unit	BAU/ml Bioequivalent Allergy Unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000 to 50000
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: 8
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	MG56-VIII
D.3.2	Product code	MG56-VIII
D.3.4	Pharmaceutical form	Sublingual spray, solution
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	N/A
D.3.9.3	Other descriptive name	POLLEN ALLERGEN EXTRACTS
D.3.9.4	EV Substance Code	SUB130721
D.3.10	Strength
D.3.10.1	Concentration unit	BAU/ml Bioequivalent Allergy Unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000 to 500000
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Sublingual spray, solution
D.8.4	Route of administration of the placebo	Sublingual use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Grass pollen allergy

Alergia frente a polen de Gramíneas

E.1.1.1

Medical condition in easily understood language

Grass pollen allergy

Alergia frente a polen de Gramíneas

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	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10036019
E.1.2	Term	Pollen allergy
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

Establish a dose-response relationship for the treatment of rhinitis/rhinoconjunctivitis due to grass pollen allergy

El objetivo principal de este ensayo consiste en la determinación de la dosis más eficaz para el tratamiento de rinitis/rinoconjuntivitis por alergia al polen de gramíneas, mediante el test de provocación nasal (TPN), tanto para el tratamiento subcutáneo como para el tratamiento sublingual.

E.2.2

Secondary objectives of the trial

As secondary objectives will be assessed efficacy, tolerance and safety of four concentrations, for both immunotherapy subcutaneous and sublingual immunotherapy.

Como objetivos secundarios se evaluarán la eficacia, la tolerancia y la seguridad de las cuatro concentraciones, tanto para la inmunoterapia subcutánea como para inmunoterapia sublingual.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Written informed consent
- Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to grass pollen allergy
- Subjects with a positive skin prick-test (wheal sixe >6 mm diameter)
Specific IgE (CAP >3) to grass pollen
- Age between 14 and 65 years
- Both genders
- Subjects capable of giving informed consent
- Subjects capable of complying with the dosing regimen
- Subjects that have not received immunotherapy in the last 5 years
- Subjects presenting sensitization to another aeroallergens and or mites, cats or dogs, but that is considered clinically not relevant or no clinical interference with the nasal provocation test.

- Sujeto que haya firmado el consentimiento informado
- Sujetos con historia clínica confirmada de alergia inhalatoria (rinitis y/o rinoconjuntivitis intermitente o persistente moderada-grave con o sin asma leve-moderada) causada por alergia al polen de gramíneas.
- Sujetos con un prick-test positivo (diámetro medio de la pápula > 6 mm) con un extracto estandarizado de polen de gramíneas realizado no antes de 6 meses al momento de la visita de inclusión.
- IgE específica (CAP) frente al representante de pólenes de gramíneas (Phleum pratense, Dactylis, Holcus o Lolium) con un valor de clase > 4 y cuya determinación no supere los 6 meses anteriores a la visita de inclusión.
- Sujetos con edad comprendida entre 14 y 65 años
- Ambos sexos
- Sujetos capaces de otorgar el consentimiento informado
- Sujetos capaces de cumplir con el régimen de dosificación
- Sujetos que no hayan recibido inmunoterapia frente a pólenes de gramíneas en los últimos 5 años
- Sujetos que presenten sensibilización a otros aeroalergenos y / o ácaros, gatos o perros, pero que sea considerada como clínicamente no relevante o sin interferencia clínica en los momentos de la realización del test de provocación nasal.

E.4

Principal exclusion criteria

- Subjects outside of the age range.
- Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to grass pollen and other allergens in the last 5 years.
- Subjects that immunotherapy may be an absolute contraindication according to the criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical Immunology, and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee may also include.
- Subjects with important symptoms of rhinoconjunctivitis /bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
-Subjects with persistent severe or not controlled asthma , with a FEV< 70 respect to the reference value in spite of the appropiate pharmacological treatment at the time of the inclusion in the trial.
-Subjects that have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial.
- Subjects that have previously submitted a serious secondary reaction during the skin prick test
-Subjects in treatment with beta blockers.
- Unstable subjects from the clinical point of view (respiratory infection, febrile, acute urticaria, etc.) at the time of the inclusion in the clinical trial
- Subject with chronic urticaria in the last 2 years or hereditary angioedema.
-Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
-Subjects with any other disease not associated with the rinitis/rinoconjuntivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multioperados, kidney diseases,...).
- Subjects with autoimmune disease (lupus, thyroiditis, etc.), tumor or with diagnosis of immunodeficiency diseases.
- Subject whose status prevents him from providing cooperation and or which present severe psychiatric disorders.
-Subject with known allergy to other components of the vaccine different from pollen of grasses.
- Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.
- Direct investigator's relatives.
- Pregnant or women at risk of pregnancy and breastfeeding women.

- Sujetos fuera del rango de edad.
- Sujetos que hayan recibido previamente inmunoterapia para el tratamiento de la rinitis/rinoconjuntivitis alérgicas por polen de gramíneas y con otros alérgenos en los 5 años previos. Tampoco podrán incluirse los sujetos en los que la inmunoterapia pueda ser objeto de contraindicación general absoluta según los criterios del Comité de Inmunoterapia de la Sociedad Española de Alergia e Inmunología Clínica y del European Allergy and Clinical Immunology Immunotherapy Subcommittee (67).
- Sujetos con síntomas importantes de rinoconjuntivitis y/o asma bronquial en los cuales la suspensión del tratamiento antihistamínico por vía sistémica esté contraindicada.
- Sujetos con asma persistente grave o no controlada, con un FEV1 <70% con respecto al valor de referencia a pesar del un tratamiento farmacológico adecuado en el momento de la inclusión en el ensayo.
- Sujetos que hayan requerido corticoides orales en las 12 semanas previas al momento de la inclusión en el ensayo.
- Sujetos que hayan presentado previamente una reacción secundaria grave durante la realización de pruebas cutáneas de diagnóstico mediante prick test.
- Sujetos en tratamiento con ß-bloqueantes.
- Sujetos inestables desde el punto de vista clínico en el momento de la inclusión en el ensayo (infección respiratoria, proceso febril, urticaria aguda, etc.)
- Sujetos con urticaria crónica durante los 2 últimos años o antecedentes de angioedema hereditario.
- Sujetos que tengan alguna patología en la que esté contraindicada la administración de adrenalina (hipertiroidismo, HTA, cardiopatía, etc.).
- Sujetos con alguna otra enfermedad no relacionada con la rinitis/rinoconjuntivitis, pero de potencial gravedad y que pueda interferir con el tratamiento y seguimiento (epilepsia, alteración psicomotora, diabetes, malformaciones, multioperados, nefropatías,..).
- Sujetos con enfermedad autoinmune (tiroiditis, lupus, etc.), enfermedades tumorales o con diagnóstico de inmunodeficiencias.
- Sujeto cuyo estado le impide ofrecer cooperación y o que presente trastornos psiquiátricos severos.
- Sujetos con alergia conocidas a los otros componentes de la vacuna diferentes al polen de gramíneas.
- Sujetos con enfermedades de la vía respiratoria inferior diferentes al asma como el enfisema o las bronquiectasias.
- Sujetos que sean familiares directos de los investigadores.
- Mujeres embarazadas o con riesgo de embarazo y mujeres lactantes.

E.5 End points

E.5.1

Primary end point(s)

- Changes in the threshold concentration required to elicit a positive response after nasal provocation test (NPT ) between the begining and end of trial

Cambio de la concentración umbral necesaria para provocar una reacción positiva después del test de provocación nasal (TPN) entre el inicio y el final del ensayo.

E.5.1.1

Timepoint(s) of evaluation of this end point

Beguining and end of the clinical trial

Principio y final del ensayo

E.5.2

Secondary end point(s)

- Dose finding skin prick test
- Immunological parameters
- Safety variables
- Comparation of each group versus placebo
- Comparation between subcutaneous immnunotherapy groups vesus sublingual mmnunotherapy groups

- Test cutáneos dosis-respuesta
- Parámetros inmunológicos
- Variables de seguridad
- Comparación de cada uno de los grupos respecto al placebo
- Comparación entre los grupos de inmunoterapia subcutánea e inmunoterapia sublingual

E.5.2.1

Timepoint(s) of evaluation of this end point

At the beginign and the end of the trial

Al principio y al final del ensayo

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

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

Yes

E.8.1.7.1

Other trial design description

Doble simulación

double dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

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

The date of the LVLP (the last patient last visit) will be regarded as the date of completion of the trial

La fecha del UVUP (última visita del último paciente) se considerará como la fecha de finalización del ensayo

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

Yes

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

140

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

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

180

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

Ninguno

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

2015-11-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-05-13

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

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