Clinical Trials Register

Summary
EudraCT Number:	2014-004429-42
Sponsor's Protocol Code Number:	DIA-Der-02-14
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:	2014-12-16
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

2014-004429-42

A.3

Full title of the trial

Open multicenter clinical trial to confirm the maximum no reactive dose of allergoid of polymerized Dermatophagoides pteronyssinus, in patients with allergic rhinoconjunctivitis or mild or moderate ashtma, who are sensitive to Dermatophagoides pteronyssinus

Ensayo clínico multicéntrico y abierto, para la confirmación de la dosis máxima no reactiva (titulación a punto final) con el alergoide Dermatophagoides pteronyssinus polimerizado administrado por vía intradérmica, en pacientes con rinoconjuntivitis alérgica o asma leve o moderado, sensibilizados al ácaro Dermatophagoides pteronyssinus.

A.3.1

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

Multicenter clinical trial with several doses of polymerized Dermatophagoides pteronyssinus to confirm the dose that does not produce a local reaction in the administration area, in patients with allergy to Dermatophagoides pteronyssinus

Estudio clínico multicéntrico con varias dosis de Dermatophagoides
pteronyssinus polimerizado para confirmar la dosis que no produce
reacción local en la zona de administración, en pacientes alérgicos a los
ácaros de la especie Dermatophagoides pteronyssinus

A.4.1

Sponsor's protocol code number

DIA-Der-02-14

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 Diagnósticos 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 Diagnósticos 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 Diagnósticos y Aplicaciones Terapéuticas, S.A.
B.5.2	Functional name of contact point	Clinical Trial Departament
B.5.3	Address:
B.5.3.1	Street Address	avenida Gregorio Peces Barba, 2, Parque Tecnologico de Leganes
B.5.3.2	Town/ city	Leganes, 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 Dermatophagoides pteronyssinus
D.3.2	Product code	Der 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 Dermatophagoides pteronyssinus
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS, DEPIGMENTED/POLYMERIZED EXTRACT
D.3.9.4	EV Substance Code	SUB84529
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	0.1
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

Allergic patients to Dermatophagoides pteronyssinus, with
rhinoconjunctivitis or mild or moderate asthma

Pacientes alergicos a Dermatophagoides pteronyssinus con rinoconjuntivitis o asma leve o moderado

E.1.1.1

Medical condition in easily understood language

Allergic patients to Dermatophagoides pteronyssinus, with
rhinoconjunctivitis or mild or moderate asthma

Pacientes alergicos a Dermatophagoides pteronyssinus con rinoconjuntivitis o asma leve o moderado

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	17.1
E.1.2	Level	PT
E.1.2	Classification code	10057631
E.1.2	Term	House dust allergy
E.1.2	System Organ Class	10021428 - Immune system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To confirm the maximum no reactive dose of Polymerized Dermatophagoides pteronyssinus, administered intradermally

Confirmar la dosis máxima no reactiva del Dermatophagoides pteronyssinus polimerizado administrado por vía intradermica

E.2.2

Secondary objectives of the trial

- Safety assessment
- Maximum erythema diameter
- Immunological biomarkers in blood sample

- Evaluación de la seguridad
- Diametro mayor de eritema
- Determinación de inmunoglobulinas en muestra de sangre

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age >=18 and <=60 years old.
2. Patients that signed the informed consent to partipate in the study.
3. Sensitive patients to Dermatophagoides pteronyssinus, demonstrated
by: Specific IgE >= 3.5 KU/L (CAP) in the year previous to the study;
Positive Prick test
4. Clinical symptoms of rhinitis or rhinoconjunctivitis or mildr
moderate ashtma.
5. Patients able to fulfill the treatment.
6. Women must have negative results in pregancy test. Pregnancy test
must be done 7 days before the start of the study.
7. Only patients that the investigator considers that are stable for their
allergy for the last six months could be participate in the study

1. Pacientes con edades comprendidas entre los ?18 y ?60 años.
2. Paciente que haya otorgado su consentimiento informado para participar en el estudio.
3. Demostración de sensibilidad a la fuente alergénica y alérgenos mayores:
Presencia de IgE específica: 3.5 KU/l (FEIA) en el año anterior previo a la administración de la primera dosis del estudio: pruebas cutáneas alérgeno?específicas positivas.
4. Demostración clínica de patología concordante con cuadros de rinitis o rinoconjuntivitis o asma leve o moderado controlado.
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.
7. Pacientes que responda a los criterios anteriores y que considere el investigador que se ha mantenido estable respecto a su enfermedad alérgica durante los 6 meses previos a la entrada en el estudio.

E.4

Principal exclusion criteria

1. Patients with concomitant inmune alterations.
2. Poli-sensitized allergic patients to relevant allergens or no-controlled
allergens.
3. Patients that received inmunotherapy against Dermatophagoides
pteronyssinus in the last 3 years.
4. Patients with serious or persistent asthma
5. Malign diseases
6. Patients with cardiovascular diseases that could get worse after
adrenalin administration
7. Active tuberculosis
8. Serious atopic eczema
9. Patients under betablockers treatment
10. Patients who decide not further to colaborate in trial
11. Pregnant or breastfeeding women
12. Severe episodes needed of hospital care related to asthma, or
systemic steroid administration in the three months previous to the start
of the assay.
13. Patients simultaneously participating in another clinical trial
14. Any other pathology that interfiere with the inmune response.
15. Chronic abuse of alcohol or other substances.

1. Enfermedades inmunológicas coexistentes.
2. Pacientes polisensibilizados que lo sean a alérgenos relevantes y no controlados.
3. Pacientes que hayan recibido inmunoterapia a ácaros en los 3 años previos al comienzo del ensayo.
4. Pacientes con asma grave o no controlado.
5. Enfermedades malignas.
6. Trastornos cardiovasculares, que puedan ser agravados por el uso de adrenalina.
7. Tuberculosis activa.
8. Eczema atópico severo.
9. Pacientes en tratamiento con betabloqueantes.
10. Pacientes que decidan interrumpir su colaboración en el estudio.
11. Mujeres embarazadas o en periodos de lactancia.
12. Presencia de exacerbaciones severas, que hayan precisado de atención en urgencias o ingresos por asma, así como de administración de esteroides sistémicos en los 3 meses previos a la selección.
13. Participación simultánea en otros ensayos clínicos.
14. Cualquier enfermedad que interfiera en la respuesta inmune.
15. Abuso crónico de alcohol o algún otro tipo de sustancia.

E.5 End points

E.5.1

Primary end point(s)

- Maximum wheal diameter

- Diametro mayor de pápula

E.5.1.1

Timepoint(s) of evaluation of this end point

At time 0 and 15 minutes after treatment administration

A tiempo 0 y 15 minutos trás la administración

E.5.2

Secondary end point(s)

- Safety assessment: record and follow-up of Adverse Reaction
- Maximun erythema diameter
- Immunological bimarkers in blood samples: specific der p 1 and der p 2 IgE and IgG4

- Evaluación de la seguridad: Documentación y seguimiento de las Reacciones Adversas
- Medición de diámetro mayor de eritema
- Inmunoglobulinas: IgE e IgG4 der p 1 y der p 2 especificas

E.5.2.1

Timepoint(s) of evaluation of this end point

- Safety assessment: along the study
- Maximun erythema diameter: 15 minutes after administration
- Immunological bimarkers: before and after the treatment

- Evaluación de la seguridad: durante todo el ensayo
- Medición de diámetro mayor de eritema: a los 15 minutos tras la administración
- Inmunoglobulinas: antes y después del tratamiento

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

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

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

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

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)

Patients could participate in next clinical trials

Los pacientes podrán participar en los ensayos siguientes

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

2015-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-02-04

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

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