Clinical Trials Register

Summary
EudraCT Number:	2014-000429-18
Sponsor's Protocol Code Number:	DIA-Phl-01-14
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-03-06
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

Spain - AEMPS

A.2

EudraCT number

2014-000429-18

A.3

Full title of the trial

Multicenter, randomized, parallel-group, double-blind, placebo-controlled clinical trial for evaluating the clinical efficacy and safety of intradermal immunotherapy with polimerised Phleum pratense, in patients with allergic rhino-conjunctivitis with or without mild to moderate asthma, sensitised to Phleum pratense pollen.

Ensayo clínico multicéntrico, doble ciego, aleatorizado y controlado con placebo, en grupos paralelos, que evalúa la eficacia clínica y seguridad de la inmunoterapia intradérmica con Phleum pratense polimerizado, en pacientes con rinoconjuntivitis alérgica con o sin asma leve o moderada, sensibilizados al polen de la gramínea Phleum pratense.

A.3.1

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

Clinical trial in several centers in which patients are administrating randomly in parallel with treatment or placebo (control). Neither the researchers nor the patients know which treatment the patiens are receiving. Present clinical trial evaluates safety and clinical efficacy of intradermal immunotherapy with polymerised Phleum pratense, in patients with allergic rhino-conjunctivitis with or without mild to moderate asthma, sensitized to Phleum pratense pollen.

Ensayo clínico en varios centros, en el que los pacientes reciben en paralelo aleatoriamente el tratamiento o el placebo (control). Ni los investigadores ni los pacientes sabrán qué tipo de tratamiento están recibiendo los pacientes. El ensayo clínico evalúa eficacia clínica y seguridad de la inmunoterapia por vía intradérmica con Phleum pratense polimerizado, en pacientes con rinoconjuntivitis alérgica con o sin asma leve o moderada, sensibilizados al polen de la gramínea Phleum pratense.

A.4.1

Sponsor's protocol code number

DIA-Phl-01-14

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	DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, 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	DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, 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	DIATER Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.
B.5.2	Functional name of contact point	Clinical Trial Department
B.5.3	Address:
B.5.3.1	Street Address	Avenida Gregorio Peces Barba, 2. Parque Tecnológico de Leganés
B.5.3.2	Town/ city	Leganés, Madrid
B.5.3.3	Post code	28918
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034914966013
B.5.5	Fax number	0034914966012
B.5.6	E-mail	j.campos@diater.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	Polymerized Phleum pratense
D.3.2	Product code	Phl p pol
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Polymerized Phleum pratense
D.3.9.3	Other descriptive name	Polymerized Phleum pratense
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.15
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	Powder and solvent for solution for injection
D.8.4	Route of administration of the placebo	Intradermal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Allergic patients to the pollen of Phleum pratense with allergic rhino-conjunctivitis with or without mild to moderate asthma.

Pacientes alérgicos al polen de Phleum prantense con rinoconjuntivitis alérgica con o sin asma leve o moderada

E.1.1.1

Medical condition in easily understood language

Allergic patients to the grass Phleum pratense, with nasal and ocular symptoms with or without mild to moderate asthma.

Pacientes alérgicos a hierba timotea (Phleum pratense) con síntomas nasales y oculares que puede cursar con o sin asma leve o moderada.

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10001728
E.1.2	Term	Allergic rhinoconjunctivitis
E.1.2	System Organ Class	100000004853

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Efficacy assessment of Polymerized Phleum pratense inmunotherapy administed intradermally

Evaluar la eficacia de la inmunoterapia específica con Phleum pratense polimerizado administrado por vía intradérmica.

E.2.2

Secondary objectives of the trial

- Efficacy assessment by a combined score of symptoms and medication
- Wheal and eritema at the site of administration measurement
- Ig E and Ig G levels
- Safety assessment

Análisis de parámetros de eficacia adicionales al índice combinado de puntuación de frecuencia y gravedad de síntomas junto a puntuación de consumo de medicación de rescate.
Medición de los tamaños de pápula y eritema tras las administraciones en cada ciclo de tratamiento.
Medición de marcadores inmunológicos (Ig E específica, Ig G4 específica).
Evaluar la seguridad de la inmunoterapia específica con Phleum pratense polimerizado administrado por vía intradérmica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age >=12 and <=50 years old
2. Patients that signed the informed consent to participate in the study
3. Allergic patients to Phleum pratense:
- Specific Ig E to Phleum pratense and or Phl p 1 >= 3.5 KU/L (CAP)
- Positive prick test to Phleum pratense, considering positive a wheal >= 3 mm with respect to the negative control
4. Patients with rinitis or rhinoconjunctivitis with or without mild to moderate ashtma in the last two years.
5. Patients able to fulfill the treatment
6. Women able to get pregnant should present a negative pregnancy test in the previous 7 days before the start of the trial, and use anticonceptive methods.

1. Pacientes con edades comprendidas entre los ?12 y 65 años.
2. Paciente que haya otorgado su consentimiento informado para participar en el estudio así como los tutores o representantes legales, si es menor de edad.
3. Demostración de sensibilidad a la fuente alergénica:
-Presencia de IgE específica a Phleum pratense y/o Phl p 1 ? 3.5 KU/L (CAP).
-Prick test positivo a Phleum pratense, esto es con un diámetro pápula ? de 3 mm con respecto al control negativo.
4. Pacientes con historia clínica de patología concordante con cuadros de rinitis o rinoconjuntivitis alérgica con o sin asma leve o moderada al menos en dos estaciones polínicas.
5. Paciente capaz de cumplir con el tratamiento.
6. Las mujeres en edad fértil deben presentar una prueba de embarazo en orina con resultado negativo en los 7 días previos a la inclusión en el ensayo, y comprometerse a utilizar métodos anticonceptivos.

E.4

Principal exclusion criteria

1. Patients with concomitant inmune diseases that could interfere with the clinical trial, as investigator discretion
2. Severe exacerbation of asthma that requires hospitalization, or FEV1<70%
3. Polisensitized patients to relevant allergens that could interfere with clinical trial.
4. Patients that received inmunotherapy against Gramineae in the last 5 years
5. Patients with uncontrolled moderate or severe ashtma
6. Malign diseases
7. Patients in which adrenaline administration is contraindicated.
8. Allergic patient to manitol.
9. Patients with active tuberculosis.
10. Patients with severe atopic eczema
11. Patients with dermographism or skin pathologies that could interfere with the assessment of prick test.
12. Psiquiatric alterations that unable the patient to fulfill with the treatment.
13. Patients treated with betablockers or IECA
14. Patients unable to fulfill the inmunotherapy treatment
15. Preagnant or breastfeeding women.
16. Fertile women that do not compromise to use anticonceptive methods.
17. Patients enrolled in other clinical trials
18. Patients of any disease that alter absorption or excretion of medicaments
19. Chronic alcohol or drugs consumption

1. Pacientes con enfermedades inmunológicas coexistentes que interfieran en el ensayo, a criterio del investigador.
2. Presencia de exacerbaciones severas, que hayan precisado de atención en urgencias o ingresos por asma, así como pacientes con asma grave o FEV1< 70%.
3. Pacientes polisensibilizados que lo sean a alérgenos relevantes clínicamente significativos que puedan interferir con la evaluación de la variable principal.
4. Pacientes que hayan recibido inmunoterapia a gramíneas en los 5 años previos al comienzo del ensayo.
5. Pacientes con asma grave o moderada no controlada.
6. Pacientes con enfermedades malignas.
7. Pacientes en los que esté contraindicado el uso de adrenalina.
8. Pacientes alérgicos o sensibilizados al manitol.
9. Pacientes con tuberculosis activa.
10. Pacientes con eczema atópico severo.
11. Pacientes con dermografismo, patologías o alteraciones cutáneas que interfieran con la evaluación de las pruebas cutáneas.
12. Pacientes con trastornos psiquiátricos que impidan el adecuado cumplimiento del programa de inmunoterapia.
13. Pacientes en tratamiento con betabloqueantes o IECA.
14. Imposibilidad de adecuado cumplimiento del programa de inmunoterapia.
15. Mujeres embarazadas o en periodos de lactancia.
16. Mujeres en edad fértil que no se comprometan a utilizar métodos anticonceptivos.
17. Participación simultánea en otros ensayos clínicos.
18. Cualquier enfermedad que interfiera en la absorción o eliminación de los fármacos en estudio.
19. Abuso crónico de alcohol o algún otro tipo de sustancia.

E.5 End points

E.5.1

Primary end point(s)

Assessment of efficacy of immunotherapy with polymerised Pheum pratense intradermally administered

Evaluar la eficacia de la inmunoterapia específica con Phleum pratense polimerizado administrado por vía intradérmica.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the first pollen count season and at the end of the second one.

Al final de la primera estación polínica y al final de la segunda

E.5.2

Secondary end point(s)

Assessment of efficacy endpoints other than combined score of symptoms and medicines.
Wheal and erythema measure after each treatment cycle .
Immunological endpoints (specific IgE and specific IgG4)
Assessment of safety of immunotherapy with polymerised Phleum pratense intradermally administered.

E.5.2.1

Timepoint(s) of evaluation of this end point

At the end of the first pollen count season and at the end of the second one.
After each treatment administration.

Al final de la primera estación polínica y al final de la segunda.
Después de cada administración

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

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)

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

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

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

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

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:

134

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

174

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

2014-05-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-09-28

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