Clinical Trials Register

Summary
EudraCT Number:	2021-003014-39
Sponsor's Protocol Code Number:	MM09-SIT-040
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-10-13
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-003014-39

A.3

Full title of the trial

Prospective, randomised, double-blind, double-dummy, placebo-controlled multicenter clinical trial of efficacy and safety with immunotherapy in patients with controlled mild to moderate allergic asthma and rhinitis/rhinoconjunctivitis, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

Ensayo clínico de eficacia y seguridad, prospectivo, aleatorizado, doble ciego, de doble simulación, controlado con placebo, multicéntrico, con inmunoterapia en pacientes con asma de leve a moderada controlada y rinitis/rinoconjuntivitis, alérgicos a Dermatophagoides pteronyssinus y/o Dermatophagoides farinae

A.3.1

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

Efficacy and Safety Evaluation for the Treatment of house dust mite induced allergic asthma and rhinitis/rhinoconjunctivitis

Evaluación de la eficacia y seguridad del tratamiento del asma y de la rinitis/rinoconjuntivitis alergica a ácaros de polvo doméstico.

A.4.1

Sponsor's protocol code number

MM09-SIT-040

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Inmunotek, S.L.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Inmunotek, S.L.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Inmunotek, S.L.
B.5.2	Functional name of contact point	Medical Department
B.5.3	Address:
B.5.3.1	Street Address	Calle Punto Mobi, 5, Parque Científico Tecnológico
B.5.3.2	Town/ city	Alcalá de Henares, Madrid
B.5.3.3	Post code	28805
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034912908942

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	MM09 allergoid-mannan conjugates SC (3.000)
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.2	Current sponsor code	MM09 allergoid-mannan conjugates
D.3.9.3	Other descriptive name	Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan
D.3.9.4	EV Substance Code	SUB236082
D.3.10	Strength
D.3.10.1	Concentration unit	AU/ml allergy unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.000
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	MM09 allergoid-mannan conjugates SL (3.000)
D.3.4	Pharmaceutical form	Sublingual spray, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.2	Current sponsor code	MM09 allergoid-mannan conjugates
D.3.9.3	Other descriptive name	Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan
D.3.9.4	EV Substance Code	SUB236082
D.3.10	Strength
D.3.10.1	Concentration unit	AU/ml allergy unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MM09 allergoid-mannan conjugates SL (9.000)
D.3.4	Pharmaceutical form	Sublingual spray, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.2	Current sponsor code	MM09 allergoid-mannan conjugates
D.3.9.3	Other descriptive name	Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan
D.3.9.4	EV Substance Code	SUB236082
D.3.10	Strength
D.3.10.1	Concentration unit	AU/ml allergy unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	9.000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Sublingual spray, solution
D.8.4	Route of administration of the placebo	Sublingual use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Etiological treatment of mild to moderate controlled intermittent or persistent allergic asthma and intermittent or persistent allergic rhinitis / rhinoconjunctivitis

Tratamiento etiológico de asma alérgica intermitente o persistente controlada de leve a moderada y rinitis/rinoconjuntivitis alérgica intermitente o persistente

E.1.1.1

Medical condition in easily understood language

House dust mite induced allergy (asthma and rhinitis/rhinoconjunctivitis)

Alergia frente a ácaros de polvo doméstico (asma y rinitis/rinoconjuntivitis)

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	20.0
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.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10034382
E.1.2	Term	Perennial allergic rhinitis
E.1.2	System Organ Class	100000004855

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
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.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10001705
E.1.2	Term	Allergic asthma
E.1.2	System Organ Class	100000004855

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 main objective of this trial is to evaluate the clinical efficacy of allergoid-mannan conjugates administered subcutaneously and sublingually, comparing with placebo in subjects with intermittent
or persistent (mild-moderate) controlled asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, by means of the combined score of symptoms and medication consumption related to the study pathologies for each trial subject

El objetivo principal de este ensayo es evaluar la eficacia clínica de los extractos alergénicos polimerizados, conjugados con manano administrados por vía subcutánea y sublingual, comparando con placebo en sujetos con asma intermitente o persistente (leve-moderada) controlada según la definición de GEMA 5.0 y GINA 2020 y rinitis/rinoconjuntivitis intermitente o persistente según la clasificación ARIA, mediante la puntuación combinada de síntomas y consumo de medicación relacionada con las patologías del estudio para cada sujeto del ensayo

E.2.2

Secondary objectives of the trial

To assess the safety & indirect efficacy of allergoid-mannan conjugates administered subcutaneously and sublingually, by comparisons between active groups & placebo, on the secondary variables:
-Free-Symptom & Free-medication days for asthma&rhinitis/Rhinoconjunctivitis
-Lung function:FEV1&PEF test
-Time to first asthma exacerbation; number, length & severity
-Time to appearance of clinical benefit
-Immunological parameters: total IgE, specific IgE&IgG4, specific IgE/total IgE index & anti-Saccharomyces cerevisiae (ASCA) IgA&IgG
- Asthma Quality of Life Questionnaire (AQLQ)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
- Asthma Control Questionnaire (ACQ)
-Visual Analogue Scale
-Consumption of health resources
-Adverse event global rate, severity & relation to the IMP per administration & participant
-Evaluation of reactions at the site of administration, systemic reactions & of any medications administered for the treatment of AA

Evaluar la seguridad y eficacia indirecta de los extractos alergénicos polimerizados, conjugados con manano administrados subcutáneamente y sublingualmente, mediante comparaciones entre grupos activos y placebo:
-Días libres de síntomas y medicación para asma y rinitis/rinoconjuntivitis
-Medición: FEV1&PEF
-Tiempo transcurrido hasta la primera aparición de las exacerbaciones asmáticas, nº, duración y gravedad
-Tiempo transcurrido hasta la aparición del beneficio clínico
-Parámetros inmunológicos: IgE total, IgE e IgG4 específicas, Índice IgE específica/IgE total e IgA e IgG anti-Saccharomyces cerevisiae(ASCA)
-Cuestionario de calidad de vida para asma(AQLQ) y rinoconjuntivitis(RQLQ)
-Cuestionario de control del asma (ACQ)
-Escala visual analógica
-Consumo de recursos sanitarios
-Tasa global, gravedad y relación de cualquier AA por administración y sujeto
-Reacciones en el lugar de la administración, sistémicas y de cualquier medicación administrada para el tratamiento de AA

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed and dated Informed Consent Form (ICF).
2. Female or male aged 12 to 60 years, both included.
3. Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
4. Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
5. Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L.
6. Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
7. Women of childbearing age must commit to using an adequate contraception method.
8. Capable of complying with dosage regimen.
9. Owning a smartphone to register symptoms and medication consumption.
10. A negative skin prick test to other aeroallergens with specific IgE < 3.5 kU/L with no clinical relevance

1. Sujeto que haya firmado el consentimiento informado.
2. Sujetos de ambos sexos con edad comprendida entre 12 y 60 años, ambos incluidos.
3. Sujetos con historia clínica confirmada de alergia inhalatoria con asma intermitente o persistente controlada leve-moderada según la definición de GEMA 5.0 y GINA 2020 y rinitis/rinoconjuntivitis intermitente o persistente según la clasificación ARIA, causada por Dermatophagoides
pteronyssinus y/o Dermatophagoides farinae). El diagnóstico de asma será válido hasta los 24 meses previos a la firma del consentimiento informado.
4. Sujetos con un prick test positivo (diámetro mayor de la pápula ≥ 5 mm) a un extracto estandarizado de Dermatophagoides pteronyssinus y/o Dermatophagoides farinae.
5. IgE específica frente a un extracto completo de D. pteronyssinus y/o D. farinae o a alguno de los componentes moleculares de las fuentes alergénicas con un valor ≥ 3,5 kU/L.
6. Las mujeres en edad fértil (desde menarquia) deben presentar una prueba de embarazo en orina con resultado negativo en el momento de su incorporación en el ensayo.
7. Las mujeres en edad fértil que participen en el ensayo, deben comprometerse a utilizar un método anticonceptivo adecuado.
8. Sujetos capaces de cumplir con el régimen de dosificación.
9. Sujetos que posean un smartphone para registro de síntomas y consumo de medicación.
10. Sujetos con prueba cutánea negativa a otros aeroalérgenos y cuya IgE específica <3,5 kU/L sin clínica relevante.

E.4

Principal exclusion criteria

1. Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
2. Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
3. Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
4. Uncontrolled or severe asthma and/or FEV1 <70% despite pharmacological treatment by the time of enrolment.
5. Intake of β-blockers.
6. Use of immunosuppressive or biological drug.
7. Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
8. Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.
9. Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure).
10. Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria.
11. Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies.
12. Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders.
13. Known allergy to any of the ingredients of the study medication except for mites.
14. Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease.
15. Breast-feeding or pregnant women.
16. Being immediate family of the investigator.
17. Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion.
18. History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.

1. Sujetos que hayan recibido inmunoterapia a los aeroalérgenos testados (D. pteronyssinus y D. farinae) en los últimos 5 años o se hayan sometido a cualquier proceso de desensibilización en
los últimos 2 años (ITO, leche, huevo, …) o estén actualmente recibiendo inmunoterapia con cualquier alérgeno.
2. Sujetos con prueba cutánea positiva a otros aeroalérgenos a excepción de epitelios con exposición y sintomatología ocasional.
3. No podrán incluirse los pacientes en los que la inmunoterapia pueda ser objeto de contraindicación general absoluta según los criterios del Comité de Inmunoterapia de la Sociedad Española de Alergia e Inmunología Clínica y del European Allergy and Clinical Immunology Immunotherapy Subcommittee.
4. Sujetos con asma grave o no controlada, y/o con un FEV1 <70% con respecto al valor de referencia a pesar del tratamiento farmacológico adecuado en el momento de la inclusión en el ensayo.
5. Sujetos en tratamiento con ß-bloqueantes.
6. Sujetos en tratamiento con fármacos inmunosupresores o biológicos.
7. Sujetos inestables desde el punto de vista clínico en el momento de la inclusión en el ensayo (exacerbación asmática aguda, infección respiratoria, proceso febril, urticaria aguda, etc.).
8. Sujetos con urticaria crónica activa durante los 2 últimos años, anafilaxia grave o antecedentes personales de angioedema hereditario.
9. Sujetos que tengan alguna patología en la que esté contraindicada la administración de adrenalina (hipertiroidismo, HTA, cardiopatía, etc.).
10. Sujetos con alguna otra enfermedad no relacionada con la rinoconjuntivitis moderada o con el asma, pero de potencial gravedad y que pueda interferir con el tratamiento y seguimiento (epilepsia, alteración psicomotora, diabetes descompensada, malformaciones, multioperados, nefropatías…),
según el criterio del investigador.
11. Sujetos con enfermedad autoinmune (tiroiditis, lupus, etc.), enfermedades tumorales o con diagnóstico de inmunodeficiencias.
12. Sujeto cuyo estado le impide ofrecer cooperación y o que presente trastornos psiquiátricos severos, según el criterio del investigador.
13. Sujetos con alergia conocida a los otros componentes del producto en investigación diferentes al alérgeno en estudio.
14. Sujetos con enfermedades de la vía respiratoria inferior diferentes al asma como el enfisema o bronquiectasias.
15. Mujeres embarazadas o en periodo de lactancia.
16. Sujetos que sean familiares directos de los investigadores.
17. Participación simultánea en otros ensayos clínicos o participación previa dentro de los 30 días anteriores a la inclusión.
18. Historial de reacciones sistémicas graves, incluidos alimentos, veneno de himenópteros, medicamentos, etc.

E.5 End points

E.5.1

Primary end point(s)

Combined score of symptoms and medication consumption throughout the trial, for both asthma and rhinitis/rhinoconjunctivitis.

Puntuación combinada de síntomas y consumo de medicación necesaria para el control del asma y la rinitis/rinoconjuntivitis

E.5.1.1

Timepoint(s) of evaluation of this end point

Beginning and end of the trial

Principio y final del ensayo

E.5.2

Secondary end point(s)

A quantitative comparison will be made both at the beginning and at the end of the trial for each subject and between the different groups of active treatment and placebo. The following parameters will be analyzed:
- Symptom score and asthma medication intake.
- Symptom score and rhinitis medication consumption.
- In asthma: Free-Symptom days and Free-Medication days
- In rhinitis/Rhinoconjunctivitis: Free-Symptom days and Free-medication days
- Lung function:FEV1 & PEF test
- Time to first asthma exacerbation; number, length & severity
-Time to appearance of clinical benefit
- Immunological parameters:
1. Total IgE
2. Specific IgE & IgG4
3. Specific IgE / total IgE index
4. Anti-Saccharomyces cerevisiae (ASCA) IgA&IgG
- Asthma Quality of Life Questionnaire (AQLQ)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
- Asthma Control Questionnaire (ACQ)
- Visual Analogue Scale (VAS)
- Consumption of health resources
- Security parameters:
1. Adverse event global rate, severity & relation to the IMP per administration & participant
2. Evaluation of reactions at the site of administration, systemic reactions & of any medications administered for the treatment of AA

Se realizará una comparación cuantitativa tanto al principio como al final del ensayo para cada sujeto y entre los distintos grupos de tratamiento activo y placebo. Se analizarán los siguientes parámetros:
- Puntuación de síntomas y consumo de medicación para asma.
- Puntuación de síntomas y consumo de medicación para rinitis.
- En asma: Días libres de síntomas y Días libres de medicación
- En rinitis/rinoconjuntivitis: Días libres de síntomas y Días libres de medicación
- Medición: FEV1 y PEF
- Tiempo transcurrido hasta la primera aparición de las exacerbaciones asmáticas, nº, duración y gravedad
- Tiempo transcurrido hasta la aparición del beneficio clínico
- Parámetros inmunológicos:
1. IgE total
2. IgE e IgG4 específicas
3. Índice IgE específica/IgE total
4. IgA e IgG anti-Saccharomyces cerevisiae (ASCA).
- Cuestionario de calidad de vida para asma (AQLQ) y para rinoconjuntivitis (RQLQ)
- Cuestionario de control de asma (ACQ)
- Escala visual analógica (EVA)
- Consumo de recursos sanitarios
- Parámetros de seguridad:
1. Tasa global, gravedad y relación de cualquier AA por administración y por sujeto.
2. Evaluación de reacciones en el lugar de la administración, reacciones sistémicas y de cualquier medicación administrada para el tratamiento de AA.

E.5.2.1

Timepoint(s) of evaluation of this end point

Beginning and end of the trial

Principio y final del ensayo

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

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)

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

The trial will finished with the database closed out.

El ensayo finalizará con el cierre de la base de datos de los resultados del ensayo.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

380

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

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

400

F.4.2

For a multinational trial

F.4.2.1

In the EEA

400

F.4.2.2

In the whole clinical trial

400

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)

At the end of the study and once the scheduled visit schedule has been completed and if the investigator considers it appropriate, patients will receive 3 cycles of study treatment free of charge. Each treatment cycle consists of a box with two vials.

Al final del estudio y una vez completado el calendario de visitas previsto y si el médico lo considera adecuado, los pacientes recibirán sin coste alguno 3 ciclos del tratamiento del estudio. Cada ciclo de tratamiento consta de una caja con dos viales.

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

2022-04-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-05-09

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