Clinical Trials Register

Summary
EudraCT Number:	2021-005529-25
Sponsor's Protocol Code Number:	API-EAG-2021-01
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:	2022-07-11
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

2021-005529-25

A.3

Full title of the trial

In vivo Biological Standardization of Gramineae Allergenic Extracts

Estandarización Biológica “in vivo” de Extracto Alergénico Gramíneas

A.3.1

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

Biological standardization of allergen extracts of pollen of Phleum pratense, Dactylis glomerata, Hordeum vulgare, Lolium perenne, Poa pratensis, Secale cereale y Triticum sativum in patients sensitized to them.

Estandarización biológica de los extractos alergénicos de Phleum pratense, Dactylis glomerata, Hordeum vulgare, Lolium perenne, Poa pratensis, Secale cereale y Triticum sativum en pacientes sensibilizados a ellos.

A.3.2

Name or abbreviated title of the trial where available

EBEA-G

A.4.1

Sponsor's protocol code number

API-EAG-2021-01

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	ASAC Pharmaceutical Inmunology, S.A.
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	ASAC Pharmaceutical Inmunology, S.A.
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	Advanced Outcomes Research SL
B.5.2	Functional name of contact point	Medical Deparment
B.5.3	Address:
B.5.3.1	Street Address	C/Tarragona 84-90, escalera C, 2ª planta- puerta 7
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08015
B.5.3.4	Country	Spain
B.5.4	Telephone number	34688724898
B.5.6	E-mail	csantos@aorsl.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	Yes
D.2.1.1.1	Trade name	APIPRICK Phleum pratense
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	PHLEUM PRATENSE POLLEN EXTRACT
D.3.2	Product code	PHLEUM PRATENSE POLLEN EXTRACT
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PHLEUM PRATENSE POLLEN EXTRACT
D.3.9.3	Other descriptive name	PHLEUM PRATENSE POLLEN EXTRACT
D.3.9.4	EV Substance Code	SUB188266
D.3.10	Strength
D.3.10.1	Concentration unit	PNU/ml protein nitrogen units/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	500 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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Product for in vivo diagnostic skin tests Producto para pruebas cutáneas de diagnóstico in vivo
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	Yes
D.2.1.1.1	Trade name	APIPRICK Dactylis glomerata
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	DACTYLIS GLOMERATA POLLEN EXTRACT
D.3.2	Product code	DACTYLIS GLOMERATA POLLEN EXTRACT
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DACTYLIS GLOMERATA POLLEN EXTRACT
D.3.9.3	Other descriptive name	DACTYLIS GLOMERATA POLLEN EXTRACT
D.3.9.4	EV Substance Code	SUB84568
D.3.10	Strength
D.3.10.1	Concentration unit	PNU/ml protein nitrogen units/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Producto para pruebas cutáneas de diagnóstico in vivo
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	Yes
D.2.1.1.1	Trade name	APIPRICK Hordeum vulgare
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	HORDEUM VULGARE POLLEN EXTRACT
D.3.2	Product code	HORDEUM VULGARE POLLEN EXTRACT
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HORDEUM VULGARE POLLEN EXTRACT
D.3.9.3	Other descriptive name	HORDEUM VULGARE POLLEN EXTRACT
D.3.9.4	EV Substance Code	SUB84545
D.3.10	Strength
D.3.10.1	Concentration unit	PNU/ml protein nitrogen units/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Producto para pruebas cutáneas de diagnóstico in vivo
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	Yes
D.2.1.1.1	Trade name	APIPRICK Lolium perenne
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	LOLIUM PERENNE POLLEN EXTRACT
D.3.2	Product code	LOLIUM PERENNE POLLEN EXTRACT
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LOLIUM PERENNE POLLEN EXTRACT
D.3.9.3	Other descriptive name	LOLIUM PERENNE POLLEN EXTRACT
D.3.9.4	EV Substance Code	SUB84560
D.3.10	Strength
D.3.10.1	Concentration unit	PNU/ml protein nitrogen units/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Producto para pruebas cutáneas de diagnóstico in vivo
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	Yes
D.2.1.1.1	Trade name	APIPRICK Poa pratensis
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	POA PRATENSIS POLLEN EXTRACT
D.3.2	Product code	POA PRATENSIS POLLEN EXTRACT
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POA PRATENSIS POLLEN EXTRACT
D.3.9.3	Other descriptive name	POA PRATENSIS POLLEN EXTRACT
D.3.9.4	EV Substance Code	SUB84562
D.3.10	Strength
D.3.10.1	Concentration unit	PNU/ml protein nitrogen units/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Producto para pruebas cutáneas de diagnóstico in vivo
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	Yes
D.2.1.1.1	Trade name	APIPRICK Secale cereale
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	SECALE CEREALE POLLEN EXTRACT
D.3.2	Product code	SECALE CEREALE POLLEN EXTRACT
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SECALE CEREALE POLLEN EXTRACT
D.3.9.3	Other descriptive name	SECALE CEREALE POLLEN EXTRACT
D.3.9.4	EV Substance Code	SUB84563
D.3.10	Strength
D.3.10.1	Concentration unit	PNU/ml protein nitrogen units/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Producto para pruebas cutáneas de diagnóstico in vivo
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	Yes
D.2.1.1.1	Trade name	APIPRICK Triticum sativum
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	TRITICUM SATIVUM POLLEN EXTRACT
D.3.2	Product code	TRITICUM SATIVUM POLLEN EXTRACT
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRITICUM AESTIVUM POLLEN EXTRACT
D.3.9.3	Other descriptive name	TRITICUM AESTIVUM POLLEN EXTRACT
D.3.9.4	EV Substance Code	SUB84566
D.3.10	Strength
D.3.10.1	Concentration unit	PNU/ml protein nitrogen units/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	500
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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Producto para pruebas cutáneas de diagnóstico in vivo
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	Yes
D.2.1.1.1	Trade name	APIPRICK control positivo
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Diclorhidrato de histamina 10 mg/ml
D.3.2	Product code	Control positivo
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diclorhidrato de histamina 10 mg/ml
D.3.9.3	Other descriptive name	Control positive
D.3.9.4	EV Substance Code	SUB12022MIG
D.3.10	Strength
D.3.10.1	Concentration unit	Gtt drop(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	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Control positivo para pruebas cutáneas de diagnóstico in vivo
D.IMP: 9
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	APIPRICK control negativo
D.2.1.1.2	Name of the Marketing Authorisation holder	ASAC PHARMACEUTICAL INMUNOLOGY SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Solución salina tamponada fenolada glicerinada
D.3.2	Product code	Control negativo
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BUFFERED SALINE SOLUTION
D.3.9.3	Other descriptive name	Control negative
D.3.9.4	EV Substance Code	SUB23008
D.3.10	Strength
D.3.10.1	Concentration unit	Gtt drop(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	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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)	No
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	Yes
D.3.11.13.1	Other medicinal product type	Control negativo para pruebas cutáneas de diagnóstico in vivo

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

Biological standarization for allergenic extracts in patients with hipersensibility to extract

Estandarización biológica de extractos alergénicos en pacientes con hipersensibilidad a los extractos

E.1.1.1

Medical condition in easily understood language

Determination of biological activity of allergenic extracts in patients with hipersensibility

Determinación de la actividad biológica de extractos alergénicos en pacientes con hipersensibilidad

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10001708
E.1.2	Term	Allergic conditions
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

The biological characterization of allergic extracts.

La caracterización biológica de los extractos alergénicos

E.2.2

Secondary objectives of the trial

To determinate the specificity and sensibility of extracts in patients with hipersensibility.
Evaluate of the tolerability and safety of the extracts

Determinar la especificidad y sensibilidad de los extractos en pacientes con hipersensibilidad.
Evaluación de la tolerabilidad y seguridad de los extractos

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1-Patient resident in a geographic area where the allergen that is standardized is prevalent
2-Age range between 18 and 65 years old for both sexs.
3-Patient diagnosed with IgE-mediated allergy to the allergen to be standardized, and the following two criteria must be positive: 1. Skin prick test with a papule whose mean diameter must be at least ≥ 3 mm than that produced by the negative control used in the diagnostic battery; 2. Specific IgE (in vitro diagnostic test) positive class 1 or higher.
4-Mean papule diameter ≥ 4 mm induced by a 10 mg/mL histamine dihydrochloride solution (positive control)
5-Subject is able to understand the objective and scope of the study and has signed the informed consent to participate in it.

INCLUSION CRITERIA FOR SENSIBILITY AND ESPECIFICITY OF THE EXTRACT: the previous criteria number 1, 2, 4 and 5 and also:
To determine the sensibility of the extract: Patient diagnosed with IgE-mediated allergy to the allergen to be evaluated and/or any allergen from its homologous group using the following criteria (both must be positive): 1- Skin prick test with a papule whose mean diameter must be at least ≥ 3 mm than that produced by the negative control used in the diagnostic battery. 2- Specific IgE (in vitro diagnostic test) positive class 1 or higher.
To determine the specificity of the extract: Patient who has not previously presented suggestive clinical manifestations coinciding with the seasonality (pollinosis) of the allergen whose allergenic extract is being evaluated and whose possible IgE-mediated sensitization to it or to any of the allergens that are members of its homologous group has been ruled out using the following criteria, both of which must be negative: 1- Direct puncture skin test (prick test) within the usual diagnostic procedures of the researcher's workplace. 2- Determination of specific IgE by validated in vitro technique.

1-Paciente residente en un área geográfica donde el alérgeno que se estandariza sea prevalente.
2-Edad incluida entre 18 y 50 años independientemente de su sexo.
3-Paciente diagnosticado de alergia IgE mediada al alérgeno que se va a estandarizar debiendo ser positivos los dos criterios siguientes: 1.Prueba cutánea (prick test) con una pápula cuyo diámetro medio debe ser al menos ≥ 3 mm que la producida por el control negativo utilizado en la batería diagnóstica; 2.IgE específica (prueba diagnóstica in vitro) positiva clase 1 o superior.
4-Diámetro medio de pápula ≥ 4 mm inducida por una solución de histamina diclorohidrato de 10 mg/mL (control positivo).
5-Que el paciente esté en condiciones de entender el objetivo y alcance del estudio y haya firmado el consentimiento informado para participar en el mismo

CRITERIOS DE INCLUSION PARA DETERMINAR LA SENSIBILIDAD Y ESPECIBILIDAD DEL EXTRACTO: ha de cumplir los criterios anteriores número 1, 2, 4 y 5 y además:
Para determinar la sensibilidad del extracto: Paciente diagnosticado de alergia IgE mediada al alérgeno que se va a evaluar y/o algún alérgeno de su grupo homólogo mediante los siguientes criterios (ambos deben ser positivos): 1-Prueba cutánea (prick test) con una pápula cuyo diámetro medio debe ser al menos ≥ 3 mm que la producida por el control negativo utilizado en la batería diagnóstica. 2-IgE específica (prueba diagnóstica in vitro) positiva clase 1 o superior.

Para determinar la especificidad del extracto: Paciente que no presente previamente manifestaciones clínicas sugerentes coincidiendo con la estacionalidad (polinosis) del alérgeno cuyo extracto alergénico se está evaluando y cuya posible sensibilización IgE mediada al mismo o a alguno de los alérgenos integrantes de su grupo homólogo haya sido descartada mediante los siguientes criterios, debiendo ser negativos los dos: 1-Prueba cutánea de punción directa (prick test) dentro de los procedimientos habituales de diagnóstico del centro de trabajo del investigador. 2-Determinación de IgE específica mediante técnica in vitro validada.

E.4

Principal exclusion criteria

-Patient has received treatment with specific immunotherapy with the extract of the allergen whose standardization is going to be carried out and/or with other allergen(s) that may interfere with skin reactivity to the extract to be standardized (cross-reactivity/ homologous groups) in the last 5 years.
-The administration of drugs capable of interfering with the results of the PTS, including antihistamines (anti-H1 and anti-H2), corticosteroids, cromoglycate or tricyclic antidepressants and that cannot be interrupted to perform skin tests.
-Patient presents lesions or tattoos on the skin area where the tests will be carried out and that at the time of the tests may influence their proper assessment.
-Any process that can alter the patient's response in the SPT, such as: Pregnancy, Dermographism, Atopic dermatitis (affecting the test area), Urticaria.
-Any other skin disease that is affecting the area where skin tests should be performed for standardization
-Inability of the patient to understand the objective/purpose of the study.
-Inability/refusal of the patient to sign the informed consent for their participation in the study.

EXCLUSION CRITERIA FOR SENSIBILITY AND ESPECIFICITY OF THE EXTRACT:
-Patient has received treatment with specific immunotherapy with an extract of the allergen whose sensitivity/specificity is going to be evaluated and/or with other allergen(s) that may/are interfering with skin reactivity to the extract to be evaluated (reactivity cross/homologous groups) in the last 5 years.
-The administration of drugs capable of interfering with the results of the PTS, including antihistamines (anti-H1 and anti-H2), corticosteroids, cromoglycate or tricyclic antidepressants and that cannot be interrupted to perform skin tests.
-That the patient presents lesions or tattoos on the skin area where the tests will be carried out and that at the time of the tests may influence their proper assessment.
-Any process that can alter the patient's response in the SPT, such as: Pregnancy, Dermographism, Atopic dermatitis (affecting the test area), Urticaria, Any other skin disease that is affecting the area where the skin tests should be performed for evaluation
-Inability of the patient to understand the objective/purpose of the study.
-Inability/refusal of the patient to sign the informed consent for their participation in the study.

-Que el paciente haya recibido tratamiento con inmunoterapia específica con extracto del alérgeno cuya estandarización se va a realizar y/o con otro/s alérgeno/s que pueda/n interferir en la reactividad cutánea al extracto que se va a estandarizar (reactividad cruzada/grupos homólogos) en los últimos 5 años.
-La administración de fármacos capaces de interferir en el resultado del SPT, incluyendo antihistamínicos (anti-H1 y anti-H2), corticoesteroides, cromoglicato o antidepresivos tricíclicos y que no pueda ser interrumpida para la realización de las pruebas cutáneas.
-Que el paciente presente lesiones o tatuajes sobre el área cutánea donde se realizarán las pruebas y que en el momento de las mismas puedan influir sobre la adecuada valoración de las mismas.
-Cualquier proceso que pueda alterar la respuesta del paciente en el SPT, como son: embarazo, dermografismo, dermatitis atópica (afectando el área del test), urticaria.
-Cualquier otra enfermedad cutánea que esté afectando al área donde deben realizarse las pruebas cutáneas para la estandarización
-Incapacidad del paciente para entender el objetivo/finalidad del estudio.
-Incapacidad/negación del paciente a firmar el consentimiento informado para su participación en el estudio

CRITERIOS DE EXCLUSION PARA DETERMINAR LA SENSIBILIDAD Y ESPECIBILIDAD DEL EXTRACTO:
-Que el paciente haya recibido tratamiento con inmunoterapia específica con extracto del alérgeno cuya sensibilidad/especificidad se va a evaluar y/o con otro/s alérgeno/s que pueda/n interferir en la reactividad cutánea al extracto que se va a evaluar (reactividad cruzada/grupos homólogos) en los últimos 5 años.
-La administración de fármacos capaces de interferir en el resultado del SPT, incluyendo antihistamínicos (anti-H1 y anti-H2), corticoesteroides, cromoglicato o antidepresivos tricíclicos y que no pueda ser interrumpida para la realización de las pruebas cutáneas.
-Que el paciente presente lesiones o tatuajes sobre el área cutánea donde se realizarán las pruebas y que en el momento de las mismas puedan influir sobre la adecuada valoración de las mismas.
-Cualquier proceso que pueda alterar la respuesta del paciente en el SPT, como son: Embarazo, Dermografismo, Dermatitis atópica (afectando el área del test), Urticaria, Cualquier otra enfermedad cutánea que esté afectando al área donde deben realizarse las pruebas cutáneas para la evaluación
-Incapacidad del paciente para entender el objetivo/finalidad del estudio.
-Incapacidad/negación del paciente a firmar el consentimiento informado para su participación en el estudio.

E.5 End points

E.5.1

Primary end point(s)

From the skin tests with the extracts to be standardized performed on sensitized patients, the area sizes of the papules induced by each of the extracts will be measured. The size of the wheal is compared to that of a prick of histamine at 10 mg/mL, to establish the relative potency of the extract.

A partir de las pruebas cutáneas con los extractos que se quieren estandarizar realizadas a pacientes sensibilizados, se medirán los tamaños de área de las pápulas inducidas por cada uno de los extractos. El tamaño de la pápula se compara con el de un prick de histamina a 10 mg/mL, para establecer la potencia relativa del extracto.

E.5.1.1

Timepoint(s) of evaluation of this end point

15 minuts

15 minutos

E.5.2

Secondary end point(s)

Based on the results obtained in the in vivo standardization, according to the sizes of the papules and the percentages of positivity of the concentrations evaluated, a concentration of the extract will be proposed for the diagnostic test. So that in this second phase its sensibility and specificity will be evaluated.
In general terms, the initial evaluation of the results implies the following calculations:
1. Determination of the area of the papule produced by each prick.
2. Calculation of the geometric mean of the areas of each duplicate

Patients who meet the following criteria will be considered positive:
-Geometric mean of the areas of the papules caused by the allergen preparations ≥ 7 mm2.
-Geometric mean of the areas of the papules caused by histamine 10 mg/ml ≥ 7 mm2.
-Geometric mean of the areas of the papules of the negative control < 7 mm2.

Based on the results obtained from the papule size and positivity of the test, the sensibility and specificity for each allergen will be determined.

En base a los resultados obtenidos en la estandarización in vivo, de acuerdo a los tamaños de las pápulas y los porcentajes de positividad de las concentraciones evaluadas, se propondrá una concentración del extracto para la prueba diagnóstica. De forma que en esta segunda fase será evaluada su sensibilidad y especificidad.
En términos generales la valoración inicial de los resultados implica los siguientes cálculos:
1. Determinación del área de la pápula producida por cada prick.
2. Cálculo de la media geométrica de las áreas de cada duplicado

Se considerarán positivos los pacientes que cumplan los siguientes criterios:
-Media geométrica de las áreas de las pápulas provocadas por las preparaciones de alérgenos ≥ 7 mm2.
-Media geométrica de las áreas de las pápulas provocadas por la histamina 10 mg/ml ≥ 7 mm2.
-Media geométrica de las áreas de las pápulas del control negativo < 7 mm2.

A partir de los resultados obtenidos de tamaño de pápula y positividad de la prueba se determinará la sensibilidad y especificidad para cada alérgeno.

E.5.2.1

Timepoint(s) of evaluation of this end point

15 minuts

15 minutos

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

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)

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

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

Control positivo y negativo con histamina

Positive and negative control with histamine

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

Última visita del último paciente

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.1.1.1

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.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

2022-10-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-10-10

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

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