Clinical Trials Register

Summary
EudraCT Number:	2014-000172-26
Sponsor's Protocol Code Number:	1301-PG-PSC-203
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:	2014-05-08
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2014-000172-26

A.3

Full title of the trial

A multicentre, open label, phase IIb clinical trial to evaluate safety, tolerability and efficacy of the depigmented modified allergen extract of two mites mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Lepidoglyphus destructor and DP/MG/14-2 Dermatophagoides pteronyssinus /Blomia tropicalis) in subjects with allergic rhinitis or rhinoconjunctivitis, with controlled allergic asthma.

Ensayo clínico de fase IIb, multicéntrico y abierto, para evaluar la seguridad, tolerabilidad y eficacia de los extractos alergénicos despigmentados modificados DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis y DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor a 200 DPP/ml, en pacientes con rinitis o rinoconjuntivitis alérgica y asma alérgica controlada.

A.3.1

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

A.4.1

Sponsor's protocol code number

1301-PG-PSC-203

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	Laboratorios LETI S.L.U
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	Laboratorios LETI, S.L.U
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	Laboratorios LETI, S.L.U
B.5.2	Functional name of contact point	Departamento Médico
B.5.3	Address:
B.5.3.1	Street Address	C/Sol, 5
B.5.3.2	Town/ city	Tres Cantos - Madrid
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	00+34917711790
B.5.5	Fax number	00+34918037472
B.5.6	E-mail	lerbiti@leti.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	DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis
D.3.4	Pharmaceutical form	Suspension 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	Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised B. tropicalis 50% (200DPP/mL)
D.3.9.2	Current sponsor code	DP/MG/14-1
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor
D.3.4	Pharmaceutical form	Suspension 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	Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised L.destructor 50% (200DPP/mL)
D.3.9.2	Current sponsor code	DP/MG/14-2
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Allergic rhinitis or rihinoconjuntivitis, with controlled allergic asthma due to D. pteronyssinus and Blomia tropicalis or Lepidoglyphus destructor sensitization.

Rinitis o rinoconjuntivitis alérgica con asma alérgica controlada por sensibilización a D. pteronyssinus y a Blomia tropicalis o Lepidoglyphus destructor.

E.1.1.1

Medical condition in easily understood language

Allergic rhinitis or rihinoconjuntivitis, with controlled allergic asthma due to D. pteronyssinus and Blomia tropicalis or Lepidoglyphus destructor sensitization.

Rinitis o rinoconjuntivitis alérgica con asma alérgica controlada por sensibilización a D. pteronyssinus y a Blomia tropicalis o Lepidoglyphus destructor.

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	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10020419
E.1.2	Term	House dust mite 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

The primary objective of this clinical trial is to evaluate the safety and tolerability of two allergens extract of mites mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) administered, using a rush build-up phase in subjects with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.

El objetivo principal del ensayo es evaluar la seguridad y la tolerabilidad de la administración de dos extractos alergénicos de mezclas de ácaros a 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis y DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) utilizando una pauta de escalado rápido en pacientes con rinitis o rinoconjuntivitis alérgica, con asma controlado.

E.2.2

Secondary objectives of the trial

The secondary objective is to evaluate the efficacy by means of the combined Symptom and Rescue Medication score (SMS) on nasal, ocular and pulmonary symptoms and their respective Rescue Medication score for the perennial treatment regimen of allergen extract of two mites mixes (DP/MG/14-1 and DP/MG/14-2) after 2 year of treatment compared with baseline. Other efficacy parameters will be evaluated: changes in ACT, VAS and RQLQ/AQOLQ.
The exploratory objective is to gain some insight of the mechanism of action of the treatment with DP/MG/14-1 and DP/MG/14-2, administered subcutaneously by measuring immunology laboratory parameters specific IgE abd IgG4 of DP/MG/14-1 and DP/MG/14-2 completed allergen extract mites.

El objetivo secundario es evaluar la eficacia comparando la puntuación combinada de síntomas y medicación de rescate (Symptom and Rescue Medication Score-SMS) en los síntomas nasales, oculares y bronquiales, así como su respectiva medicación de rescate de la pauta perenne de dos combinaciones de extractos alergénicos de ácaros (DP/MG/14-1 y DP/MG/14-2) tras 2 años de tratamiento y en comparación con los valores basales. Se evaluarán otros parámetros de eficacia, incluyendo los cambios en los cuestionarios específicos de enfermedad ACQ, EVA y RQLQ/AQOLQ.
El objetivo exploratorio es evaluar el mecanismo de acción del tratamiento con DP/MG/14-1 y DP/MG/14-2 administrado por vía subcutánea mediante la medición de los parámetros inmunoserológicos de laboratorio IgE e IgG4 específicos de los extractos alergénicos completos de ácaros DP/MG/14-1 y DP/MG/14-2.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Subject has provided appropriately signed and dated written informed consent.
2.Men and women aged ? 18 years and ? 70 years of age at Visit 1.
3.Has an FEV1 value ? 80% of predicted normal value at Visit 1.
4.Individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe (see Annex 8 in order to verify the disease burden) for at least the preceding year, with controlled asthma, caused by double sensitization against Dermatophagoides pteronyssinus (DPT) and Lepidoglyphus destructor or Dermatophagoides pteronyssinus and Blomia tropicalis.
?The IgE-mediated sensitization must be verified by the following:
o Suggestive medical history, and
o Specific IgE to D. pteronyssinus and Lepidoglyphus destructor or D. pteronyssinus and Blomia tropicalis ? 0,7 KU/l (classe II). The IgE results are valid if performed within one year prior to V1, and
o Positive skin prick test (SPT) to D. pteronyssinus and Lepidoglyphus destructor or Blomia tropicalis.
A SPT will be considered positive when it produces a wheal whose diameter is at least 3 mm. The negative control must not develop a wheal or it must be smaller than the DPT one in 3 mm.
- Asthmatic subjects can be included in the trial only if allergic asthma is controlled according to the Global Initiative for Asthma (GINA 2010)
- Asthmatic subjects must be stable within 3 months prior to Visit 1 and on a stable inhaled steroid dose within 6 weeks prior to Visit 1 and throughout the study.
5.Patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic. Patients sensitized to animal dander can participate only if they are not exposed.
6.If a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
7.If a female is of childbearing potential, the subject must be non-lactating and non-pregnant (with a negative pregnancy test result at Visit 1) and must correctly use an effective method of contraception during the study. An effective method of contraception is defined as one that results in a failure rate of less than 1% per year. The following are allowed methods of contraception when used continuously and properly: hormonal contraceptives administered by implant, injection, or orally; complete abstinence; partner?s vasectomy if the female has not more than one partner. Barrier methods (e.g., preservatives) are only considered effective if used together with one of the above.

1.Pacientes que hayan fechado y firmado adecuadamente el consentimiento informado por escrito.
2.Hombres y mujeres con edades comprendidas entre 18 y 70 años (ambas inclusive) en el momento de la Visita 1.
3.Presentar un valor de FEV1 ? 80% del valor normal previsto en la Visita 1.
4.Sujetos que sufran de rinitis alérgica permanente o rinoconjuntivitis moderada-severa (ver Anexo 8 para verificar la carga de la enfermedad) durante al menos el año anterior, con asma controlada, causada por doble sensibilización contra Dermatophagoides pteronyssinus y Lepidoglyphus destructor o Dermatophagoides pteronyssinus y Blomia tropicalis.
-Esta sensibilización mediada por IgE debe ser verificada por:
o Historia clínica sugestiva de sensibilización, e
o IgE específica ? 0,7 KU/l (clase II) para D. pteronyssinus y Lepidoglyphus destructor o para D. pteronyssinus y Blomia tropicalis. Los resultados de IgE son válidos si se realizaron dentro del año previo a la Visita 1, y
o Prueba positiva de punción cutánea (Skin Prick Test, SPT) para D. pteronyssinus y Lepidoglyphus destructor o D. pteronyssinus y Blomia tropicalis.
Se considerará positivo un SPT cuando se produzca un habón de diámetro superior los 3 mm. El control negativo no debe inducir un habón o éste debe ser más pequeño que el inducido por D. pteronyssinus en 3 mm.
- Los pacientes asmáticos pueden ser incluidos en el estudio sólo si el asma está controlado de acuerdo con los criterios de la Global Initiative for Asthma (GINA actualización 2010).
- Los pacientes asmáticos deben haber permanecido estables durante al menos los 3 meses previos a la Visita 1 y tratados con una dosis estable de esteroides inhalados durante las 6 semanas previas a la Visita 1, además de a lo largo de todo el estudio.
5.Los pacientes sensibilizados a coalérgenos como al polen de árboles, gramíneas o malezas, hongos o epitelios de animales no pueden participar en el estudio si presentan síntomas. Los pacientes sensibilizados a epitelios de animales pueden participar en el estudio solo si no están expuestos.
6.Si una mujer no tiene capacidad de concebir, este hecho deberá demostrarse en base a una condición postmenopáusica de al menos un año o en base a la existencia de esterilización quirúrgica previa (por ejemplo, ligadura de trompas bilateral, ooforectomía bilateral, o histerectomía).
7.Si una mujer está en edad fértil, deberá ser no lactante y no estar embarazada (según resultado negativo en la prueba de embarazo realizada en la Visita 1), además de utilizar correctamente un método anticonceptivo eficaz durante el curso del estudio. Los métodos anticonceptivo eficaces se definen como aquellos que resultan en una tasa de fracaso inferior al 1% por año. Los siguientes métodos anticonceptivos están autorizados cuando se utilizan de forma constante y adecuada: anticonceptivos hormonales administrados por implantes, inyecciones o vía oral; abstinencia completa; vasectomía de la pareja si la mujer no tiene más de una pareja. Los métodos de barrera (por ejemplo, preservativos) sólo se considerarán eficaces si se utilizan junto con alguno de los anteriores.

E.4

Principal exclusion criteria

1.Any contraindication for treatment with allergen specific immunotherapy.
2.Subjects with a previous history of anaphylaxis.
3.Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
4.Has uncontrolled asthma, according to Global Initiative for Asthma Guidelines (GINA 2010).
5.Acute or chronic infectious conjunctivitis.
6.Has acute or chronic inflammatory or infectious airways disease.
7.Has chronic structural diseases of the affected organ (e.g. eye, nose, lung).
8.History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
9.Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
10.Has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.
11.Subjects with chronic urticaria.
12.Subjects with moderate-severe atopic dermatitis (subjects with a SCORAD value >30 can not participate in the study).
13.Has had active malignant disease during the previous 5 years.
14.Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient.
15.Has used immunotherapy with allergenic extracts of storage or house dust mites within the last 5 years or is receiving allergen specific immunotherapy with other allergens during the study period.
16.Has used systemic and/or topical treatment with beta-blocker drugs within 1 week prior to Visit 2 (first IMP administration).
17.Used psychotropic, tricyclic, tetracyclic and MAOI antidepressants within 1 month prior to Visit 1. It will not be allowed to perform a washout period of psychotropic or antidepressants to enter the study because of the risks of interrupting the treatment.
18.Used systemic corticosteroids within 3 months prior to Visit 1.
19.Treatment with substances interfering with the immune system 2 weeks before Visit 2 (first IMP administration).
20.Immunization with prophylactic (bacterial or viral) vaccines within 7 days prior to Visit 1 and within 7 days prior to visit 2 (first IMP administration). Prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after immunotherapy and the next immunotherapy dose is administered at least 14 days later.
21.Exposure to any investigational drug within one month or 6 half lives of the drug (whichever is longer).
22.Has abused alcohol, drugs or medications within the past year prior to Visit 1.
23.Lack of cooperation or compliance.
24.Donation of germ cells, blood, organs and/or bone marrow for the duration of the study.

1. Cualquier contraindicación para el tratamiento con inmunoterapia específica de alérgeno.
2. Pacientes con historia previa de anafilaxia.
3. Pacientes con ingreso hospitalario debido a exacerbaciones asmáticas dentro del año anterior a la Visita 1.
4. Presencia de asma alérgica no controlada, de acuerdo con los criterios de la Global Initiative for Asthma (GINA 2010)
5. Diagnóstico de conjuntivitis infecciosa aguda o crónica.
6. Enfermedades inflamatorias o infecciosas agudas o crónicas en las vías respiratorias.
7. Enfermedades estructurales crónicas del órgano diana (p.e. ojos, nariz, pulmón).
8. Historia previa o presencia de enfermedades confirmadas o potenciales del sistema inmunitario, tanto enfermedades autoinmunes como inmunodeficiencias con relevancia clínica.
9. Cualquier trastorno que contraindique el empleo de adrenalina (p.e. el hipertiroidismo).
10. Enfermedades no controladas graves que impliquen un riesgo incrementado para los sujetos que participen en este estudio, incluyendo las siguientes pero no limitado a: insuficiencia cardiaca, cualquier enfermedad pulmonar grave o inestable, enfermedades endocrinológicas, enfermedades hepáticas, renales, vasculares o hematológicas clínicamente relevantes.
11. Pacientes con urticaria crónica.
12. Pacientes con dermatitis atópica moderada o grave (los sujetos con un valor en el índice SCORAD > 30 no pueden participar en el estudio).
13. Enfermedad maligna con actividad en los últimos 5 años.
14. Existencia de un parámetro de laboratorio anormal clínicamente relevante o bien alteración de constantes vitales que puedan aumentar el riesgo para el paciente en el estudio.
15. El uso de inmunoterapia con extractos alergénicos de ácaros del polvo doméstico o de almacén durante los últimos 5 años o el tratamiento con inmunoterapia específica con otros alérgenos durante el período de estudio.
16. Tratamiento sistémico o tópico con fármacos betabloqueantes en la semana previa a la visita 2 (correspondiente a la primera administración del PEI).
17. Uso de antidepresivos psicotrópicos, tricíclicos, tetracíclicos o IMAO dentro del mes previo a la Visita 1. No se permitirá la retirada de antidepresivos o psicotrópicos para participar en el estudio, a causa del riego que supone interrumpir el tratamiento.
18. Uso de corticosteroides sistémicos en los 3 meses previos a la Visita 1.
19. Tratamiento con sustancias que interfieren con el sistema inmunitario 2 semanas antes de la Visita 2.
20. Inmunización con vacunas profilácticas (bacterianas o virales) en los 7 días anteriores a la Visita 1 y en los 7 días anteriores a la Visita 2 (correspondiente a la primera administración de PEI). Las vacunas profilácticas están permitidas durante el período de tratamiento con el PEI siempre que se administren al menos una semana después del PEI, y cuando la siguiente administración del PEI se produzca al menos 14 días después de la vacuna.
21. Exposición a cualquier fármaco en fase de investigación durante un mes o el equivalente a seis veces la vida media del producto (el período que resulte mayor).
22. Abuso de alcohol, drogas o fármacos en el año anterior a la Visita 1.
23. Falta de cooperación o de cumplimiento.
24. Donación de células germinales, sangre, órganos y/o médula ósea durante la duración del estudio.

E.5 End points

E.5.1

Primary end point(s)

Subjects (%) suffering from immediate or delayed systemic ? grade 2 reactions, according to EACCI 2006 classification, along the study.

Número de pacientes (%) que presenten al menos una reacción sistémica inmediata o tardía de grado 2 o superior, según clasificación de la EAACI de 2006, durante el estudio.

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.

Seguridad: reacciones adversas locales y sistémicas (clasificación EAACI) durante las primeras 24 y 48 horas tras el tratamiento.

E.5.2

Secondary end point(s)

?Patients (%) sufering from immediate or delayed local reactions classified by the diameter of induration (< 5 cm, 5-10 cm o > 10 cm)and dose received
?Patients (%) suffering from immediate or delayed systemic reactions classified by grade (EACCI classification) and dose received
?Patients (%) withdrawn from the study due to local reactions classified by dose received
?Patients (%) withdrawn from the study due to local reactions classified by dose received during the build-up phase
?Patients (%) withdrawn from the study due to systemic reactions classified by dose received
?Patients (%) withdrawn from the study due to systemic reactions classified by dose received during the build-up phase
?Patients (%) with adverse events (AE) classified by dose received
?Number of immediate or delayed local reactions classified by diameter of induration (< 5 cm, 5-10 cm o > 10 cm) and dose received
?Number of immediate or delayed systemic reactions classified by grade (EACCI classification) and dose received
?Change of lung function parameters before and after each administration of the IMP.
?Change from baseline to Visit 4 in laboratory safety parameters.
?Change in symptoms and rescue medication score from baseline to final visit.
?Change in symptoms score (nasal, ocular and pulmonary symptoms) from baseline to final visit.
?Change in rescue medication score from baseline to final visit.
?Patients (%) with an improvement in symptoms and rescue medication score after treatment compared to baseline.
?Patients (%) with an improvement in symptoms score after treatment compared to baseline.
?Patients (%) with an improvement in rescue medication score after treatment compared to baseline.
?Change from baseline to final visit in ACT.
?Patients (%) with an improvement in quality of life questionnaires after treatment compared to baseline.
?Patients (%) with an improvement in VAS after treatment compared to baseline.

Exploratory immunological parameters:
Immunological response measured by immunological parameters (specific IgE and IgG4) after receiving the administration of the first maintenance dose at 4 weeks of starting treatment and compared to baseline values.

?Número de pacientes (%) que padecen reacciones locales inmediatas o tardías clasificados según diámetro de induración (< 5 cm, 5-10 cm o > 10 cm) y dosis recibida.
?Número de pacientes (%) que padecen reacciones sistémicas inmediatas o tardías clasificados según grado (clasificación de la EAACI) y dosis recibida.
?Número de pacientes (%) retirados del estudio debido a reacciones locales clasificados según dosis recibida.
?Número de pacientes (%) retirados del estudio debido a reacciones locales clasificados por dosis recibida durante la fase de escalado rápido.
?Número de pacientes (%) retirados del estudio debido a reacciones sistémicas clasificados según dosis recibida.
?Número de pacientes (%) retirados del estudio debido a reacciones sistémicas clasificados según dosis recibida durante la fase de escalado rápido.
?Número de pacientes (%) con acontecimientos adversos (AA) clasificados según dosis recibida.
?Número de reacciones locales inmediatas o tardías clasificadas según diámetro de induración (< 5 cm, 5-10 cm y > 10 cm) y dosis recibida.
?Número de reacciones sistémicas inmediatas o tardías clasificadas según grado (clasificación de EAACI) y dosis recibida.
?Cambio en parámetros de la función pulmonar antes y después de cada administración del PEI.
?Cambio entre el inicio y la visita 4 en los parámetros de seguridad de laboratorio.
?Cambio en la puntuación combinada de síntomas y medicación de rescate desde el inicio hasta la última visita.
?Cambio en la puntuación de síntomas (síntomas nasales, oculares y bronquiales) desde el inicio hasta la última visita.
?Cambio en la puntuación medicación de rescate desde el inicio hasta la última visita.
?Pacientes (%) con mejora en la puntuación combinada de síntomas y medicación de rescate después del tratamiento y en comparación con el valor basal.
?Pacientes (%) con mejora en la puntuación de síntomas después del tratamiento y en comparación con el valor basal.
?Pacientes (%) con mejora en la puntuación combinada de medicación de rescate después del tratamiento y en comparación con el valor basal.
?Cambio en ACQ desde el inicio a la visita final.
?Pacientes (%) con una mejora en la puntuación de los cuestionarios de calidad de vida (AQLQ y RQLQ) después del tratamiento y en comparación con el valor basal.
?Pacientes (%) con una mejora en la puntuación de la EVA después del tratamiento y en comparación con el valor basal.

Parámetros inmunológicos exploratorios:
Respuesta inmunológica al tratamiento medida mediante parámetros inmunológicos (IgE e IgG4 específicas) tras recibir la administración de la primera dosis de mantenimiento a las 4 semanas de haber iniciado el tratamiento, y respecto a los valores basales.

E.5.2.1

Timepoint(s) of evaluation of this end point

Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.
Efficacy: during follow up period: visit 5, 6, 7 and 8.
Inmunological response at screening and visit 4, 6 and 8.

Seguridad: reacciones adversas locales y sistémicas (clasificación EAACI) durante las primeras 24 y 48 horas tras el tratamiento.
Eficacia: durante el periodo de seguimiento: visita 5, 6, 7 y 8.
Respuesta inmunológica: en la visita de selección y en la visita 4, 6 y 8.

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)

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)

Information not present in EudraCT

E.8.2.2

Placebo

E.8.2.3

Other

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: Last visit of the last subject participating in the trial

UVUP: Última visita del último paciente que participa en el 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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

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)

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

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)

After the end of the study and if the investigator considered appropiate, the patients will be given the option to benefit from receiving a full course of treatment, 3 years in total, for their mite allergy with allergenic extracts which are marketed.

Después del estudio y siempre que el médico lo considere oportuno, a los pacientes se les proporcionará el tratamiento con el extracto actualmente comercializado para su alergia a ácaros, con el fin de recibir un ciclo completo, 3 años en total.

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

2014-06-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-02

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials