Clinical Trials Register

Summary
EudraCT Number:	2017-000971-97
Sponsor's Protocol Code Number:	AL-X-01
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:	2017-06-20
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

2017-000971-97

A.3

Full title of the trial

Safety and tolerability of shortened up-dosing with Alutard SQ

Seguridad y tolerabilidad de una pauta acortada de tratamiento con Alutard SQ

A.3.1

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

Safety and tolerability of shortened up-dosing with Alutard SQ

Seguridad y tolerabilidad de una pauta acortada de tratamiento con Alutard SQ

A.4.1

Sponsor's protocol code number

AL-X-01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ALK Abelló A/S
B.1.3.4	Country	Denmark
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	ALK Abelló A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ALK-Abelló S.A.
B.5.2	Functional name of contact point	Departamento Médico
B.5.3	Address:
B.5.3.1	Street Address	Calle Miguel Fleta, 19
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28037
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034913276127
B.5.5	Fax number	0034913276128
B.5.6	E-mail	clinicaltrials.madrid@alk.net

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Alutard SQ 6 Gramíneas y secale
D.2.1.1.2	Name of the Marketing Authorisation holder	ALK-Abelló Arzneimittel GmbH, Griegstraße 75 (Haus 25), d_22763 Hamburg
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Alutard SQ 6 Gramíneas y secale
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.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	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	Yes
D.2.1.1.1	Trade name	Alutard SQ 6 Gramíneas y secale
D.2.1.1.2	Name of the Marketing Authorisation holder	ALK-Abelló Arzneimittel GmbH, Griegstraße 75 (Haus 25), D-22763 Hamburg
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Alutard SQ 6 Gramíneas y secale
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.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	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	Yes
D.2.1.1.1	Trade name	Alutard SQ abedul
D.2.1.1.2	Name of the Marketing Authorisation holder	ALK-Abelló Arzneimittel GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Alutard SQ abedul
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.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Alutard SQ Dermatophagoides mezcla
D.2.1.1.2	Name of the Marketing Authorisation holder	ALK-Abelló Arzneimittel GmbH, Griegstraße 75 (Haus 25), D-22763 Hamburg
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Alutard SQ Dermatophagoides mezcla
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.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	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 rhinoconjunctivitis induced by grass pollen, birch pollen and house dust mites

Rinoconjuntivitis alérgica a polen de gramíneas, abedul o ácaros del polvo doméstico.

E.1.1.1

Medical condition in easily understood language

Hayfever caused by grass pollen, birch pollen or house dust mites

Alergia al polen de gramíneas, abedul o ácaros del polvo doméstico.

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

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	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

The objective of the trial is to evaluate the safety and tolerability of a 7-injection up-dosing schedule with Alutard SQ 6-grasses and rye, birch and house dust mite mix compared with the 11-injection up-dosing schedule established for pollen allergens.

El objetivo del ensayo es valorar la seguridad y tolerabilidad de una pauta de inicio de dosis de 7 inyecciones con Alutard SQ 6 gramíneas y secale, Alutard SQ abedul y Alutard SQ Dermatophagoides mezcla, comparado con la pauta de inicio de 11 inyecciones establecida para pólenes.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

I1. Written informed consent obtained before any trial related procedures are performed.
I2. Male or female aged 12–65 years at the time of consent.
I3. The subject fulfils one of the following criteria:
a. Male
b. Female, infertile
c. A female subject of child-bearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods until end of treatment visit.
I4. Documented clinically relevant history of moderate-to-severe grass pollen, birch pollen or house dust mite-induced rhinoconjunctivitis with or without controlled asthma despite having received treatment with symptomatic medication during the previous 2 grass, birch pollen seasons or 2 years, respectively.
I5. Positive SPT response to grass, birch or house dust mite allergens (wheal diameter ≥ 3 mm) at screening corresponding with the allergy history (dominant allergy to grass, birch or house dust mites according to I4.).
I6. Documented positive IgE response (≥ IgE CAP class 2 or equivalent) in the allergy history to grass, birch or house dust mite allergens in the previous 2 years corresponding with the allergy history (dominant allergy to grass, birch or house dust mites according to I4.).
I7. The subject must be willing and able to comply with the trial protocol.

I1. Consentimiento informado obtenido antes de la realización de cualquier procedimiento del ensayo.
I2. Hombre o mujer entre 12-65 años de edad en el momento de la firma del consentimiento.
I3. El sujeto cumple uno de los siguientes criterios:
a. Hombre
b. Mujer, no fértil
c. Una mujer fértil debe tener un test de embarazo negativo y debe estar conforme en utilizar un método anticonceptivo apropiado hasta el final del tratamiento.
I4. Historia clínica relevante y documentada de rinoconjuntivitis alérgica moderada o severa inducida por polen de gramíneas, polen de abedul o ácaros, con o sin asma controlado a pesar de haber recibido tratamiento sintomático durante las dos estaciones polínicas previas en el caso de gramíneas o abedul o durante los dos años previos en el
caso de ácaros.
I5. En la visita de selección, SPT positivo al extracto alergénico de polen de gramíneas, abedul o ácaros del polvo doméstico (diámetro de pápula ≥3 mm), que se corresponda con la historia de alergia (alergia dominante a gramíneas, abedul o ácaros del polvo doméstico de acuerdo con el criterio de inclusión I4).
I6. IgE específica positiva documentada en la historia clínica en los dos últimos años (≥ IgE CAP clase 2 o equivalente) frente a gramíneas, abedul o ácaros, que se corresponda con la historia de alergia (alergia dominante a gramíneas, abedul o ácaros de acuerdo al criterio de inclusión I4).
I7. Los sujetos deben querer y ser capaces de cumplir los procedimientos del ensayo clínico.

E.4

Principal exclusion criteria

E1. Asthma subjects at risk of exacerbation and/or with inadequate symptom control defined as the presence of: loss of symptom control within the last four weeks (e.g. increase in daytime symptoms, nightly wakening, increased need of medication, activity limitations), according to GINA guideline (2).
E2. Inadequately treated bronchial asthma or bronchial asthma with permanently impaired lung function (in adults: FEV1 < 70% of predicted value after adequate pharmacologic treatment, in adolescents: FEV1 < 80% of predicted value after adequate pharmacologic treatment)
E3. Irreversible respiratory damage such as emphysema or dilatation of the bronchi (bronchiectasis)
E4. Previous treatment with immunotherapy to an allergen related to the dominant allergy as defined in I4. (grass pollen, birch or house dust mite allergen or a cross-reacting allergen) within the past 5 years
E5. Ongoing treatment with any allergy immunotherapy product
E6. Has a history or current evidence of any condition, treatment, laboratory values out of range or other circumstance that in the opinion of the investigator are clinically relevant and might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial
E7. History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction)
E8. History of recurrent (defined as 2 or more episodes) generalised urticaria during the last 2 years
E9. History of drug-induced (including allergy immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
E10. Any clinically relevant chronic disease (≥ 3 months duration) (e.g. cystic fibrosis, malignancy, malabsorption or malnutrition, renal or hepatic abnormality, or any other diseases that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subjects)
E11. Systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease)
E12. Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
E13. Currently treated with tricyclic antidepressants, catecholamine-O-methyltransferase inhibitors and/or mono amine oxidase inhibitors
E14. Treatment with antidepressant medication with antihistaminic effect (e.g. doxepin, mianserine)
E15. Treatment with antipsychotic medications with antihistaminic effect (e.g. chlorpromazine, levomepromazine, clozapine, olanzapine, tioridazine)
E16. Treatment with anti-IgE drugs (e.g. omalizumab) within 130 days/5 half-lives of the drug, which ever the longest
E17. Treatment with systemic and/or topical β-blockers
E18. Current participation in other clinical trials and/or use of an investigational drug within 30 days/5 half-lives of the drug, which ever the longest, prior to screening
E19. History of allergy, hypersensitivity or intolerance to an excipient of the investigational drug (except grass, birch or house dust mite allergens)
E20. Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent, or grandchild
E21. History of alcohol or drug abuse
E22. Lactating at screening

E1. Sujetos asmáticos con riesgo de exacerbación asmática y/o control inadecuado de los síntomas definido como la presencia de: pérdida del control de síntomas en las últimas 4 semanas (ej. Incremento en los síntomas diurnos, despertares nocturnos, aumento en la necesidad de medicación, limitaciones de actividad) de acuerdo a la guía GINA (2).
E2. Asma bronquial inadecuadamente tratada o con función pulmonar permanentemente deteriorada, definido como FEV1 < 70% del valor teórico tras tratamiento farmacológico adecuado en adultos (FEV1 < 80% en adolescentes)
E3. Daño respiratorio irreversible como enfisema o dilatación bronquial (bronquiectasia)
E4. Inmunoterapia previa en los 5 años anteriores con extractos alergénicos relacionados con la alergia dominante, según el criterio de inclusión I.4 (polen de gramíneas, polen de abedul o ácaros del polvo doméstico o alérgenos con reactividad cruzada).
E5. Inmunoterapia específica concomitante con cualquier alérgeno.
E6. El sujeto tiene antecedentes o evidencia actual de cualquier condición, tratamiento, valores anormales de laboratorio u otra circunstancia que en opinión del investigador sean clínicamente relevantes y puedan exponer al sujeto a riesgos al participar en el ensayo, influir en los resultados del ensayo, o interferir con la participación del sujeto durante toda la duración del ensayo.
E7. Antecedentes de anafilaxia con síntomas cardiorrespiratorios (causado por inmunoterapia, ejercicio, alergia alimentaria, medicamentos o reacciones idiopáticas).
E8. Antecedentes de urticaria generalizada recurrente (definida como dos o más episodios) durante los dos últimos años.
E9. Antecedentes de angioedema facial inducido por medicamentos (incluyendo inmunoterapia) o antecedentes familiares (padres y hermanos) de angioedema hereditario.
E10. Cualquier enfermedad crónica clínicamente relevante (>3 meses de duración) (p. ej. fibrosis quística, tumores, malabsorción o malnutrición, enfermedades renales o hepáticas y otras patologías que en opinión del investigador pudieran interferir en las evaluaciones del ensayo o en la seguridad del sujeto).
E11. Enfermedades sistémicas del sistema inmune (p. ej. diabetes insulinodependiente, enfermedad autoinmune, enfermedad por complejo inmune o inmunodeficiencias)
E12. Tratamiento con inmunosupresores (código ATC L04 o L01) en los tres meses previos a la inclusión.
E13. Tratamiento concomitante con antidepresivos tricíclicos, inhibidores de la catecolamina-O-metiltransferasa e inhibidores de mono amino oxidase.
E14. Tratamiento con antidepresivos tricíclicos con efecto antihistamínico (ej. doxepina, mianserina)
E15. Tratamiento con medicamentos antipsicóticos con efecto antihistamínico (clorpromazina, levomepromazina, clozapina, olanzapina, tioridazina)
E16. Tratamiento previo con fármacos anti-IgE (ej. omalizumab) en los 130 días/5 vidas medias del fármaco anteriores (se considerará el más largo).
E17. Tratamiento con betabloqueantes sistémicos o tópicos.
E18. Tratamiento con un medicamento en investigación en los 30 días/5 vidas medias del fármaco (se considerará el más largo) previo a la inclusión.
E19. Historia de alergia, hipersensibilidad o intolerancia a alguno de los excipientes del medicamento en investigación (excepto alérgenos de gramíneas, abedul o ácaros del polvo doméstico).
E20. Ser investigador, personal del ensayo o familiar inmediato de éstos, definidos como esposa, padres, hijos, abuelos o nietos.
E21. Historia de abuso de alcohol o drogas.
E22. Mujeres en periodo de lactancia

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the number of investigational medicinal product (IMP)-related treatment emergent adverse events (TEAEs).

El criterio de evaluación principal es el número de acontecimientos adversos relacionados con el medicamento en investigación

E.5.1.1

Timepoint(s) of evaluation of this end point

During the course of the trial.

Durante el desarrollo del ensayo.

E.5.2

Secondary end point(s)

Secondary endpoints are:
- Number of local reactions
- Number of systemic reactions
- Number of early/delayed systemic reactions
- Number of Adverse Events (AEs) leading to discontinuation
- Number of serious AEs (SAEs)
- Change in vital signs (resting blood pressure, heart rate) from preinjection to 60-minutes post-injection at each IMP injection visit
- Percentage of IMP injections with a decrease in peak expiratory flow (PEF) values > 20% from pre-injection to 60-minutes post-injection for each dose
- Changes observed in physical examination from screening to last planned assessment

Criterios de evaluación secundarios:
- Número de reacciones locales.
- Número de reacciones sistémicas.
- Número de reacciones sistémicas inmediatas y tardías.
- Número de acontecimientos adversos que produzcan la interrupción del tratamiento.
- Número de acontecimientos adversos graves.
- Cambios en signos vitales (tensión arterial y ritmo cardiaco) antes y 60 minutos después de la inyección del medicamento en investigación.
- Porcentaje de dosis administradas del medicamento en investigación que produzcan una disminución del pico flujo espiratorio (PEF) mayor del 20% entre el valor previo a la inyección y tras 60 minutos.
- Cambios en el examen físico desde la visita de selección hasta la última evaluación realizada.

E.5.2.1

Timepoint(s) of evaluation of this end point

During the course of the trial

Durante el desarrollo 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

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tolerabilidad

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Incremento de dosis esquema 7 inyecciones Alutard® SQ vs esquema 11 inyecciones establecido

7-injection-up-dosing with Alutard SQ compared with 11-injection-up-dosing Alutard SQ

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

End of trial: Date of the last phone follow-up (31-May-2018 plus two weeks).

Fin del ensayo: Fecha de última llamada de seguimiento (dos semanas después del 31 de mayo de 2018).

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

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:

240

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.4.2

For a multinational trial

F.4.2.1

In the EEA

320

F.4.2.2

In the whole clinical trial

320

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 trial, the investigator must advise trial subjects on access to appropriate and available treatment. Such treatment will not be sponsored by ALK.

Tras la finalización del ensayo, el investigador debe advertir a los sujetos del ensayo sobre el acceso a un tratamiento adecuado y disponible. Dicho tratamiento no estará financiado por ALK.

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

2017-07-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-05-29

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