Clinical Trials Register

Summary
EudraCT Number:	2012-002177-62
Sponsor's Protocol Code Number:	SU-M-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:	2012-08-09
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

2012-002177-62

A.3

Full title of the trial

A Dose Response Evaluation of SLIToneULTRA HDM Mix Immunotherapy

Estudio dosis-respuesta de la inmunoterapia con SLIToneULTRA
Dermatophagoides mezcla

A.3.1

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

A Dose Response Evaluation of SLIToneULTRA HDM Mix Immunotherapy

Estudio dosis-respuesta de la inmunoterapia con SLIToneULTRA
Dermatophagoides mezcla

A.3.2

Name or abbreviated title of the trial where available

The SUMMIT Trial

Estudio SUMMIT

A.4.1

Sponsor's protocol code number

SU-M-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 A/S
B.5.2	Functional name of contact point	Mikkel Walmar
B.5.3	Address:
B.5.3.1	Street Address	Bøge Allé 6-8
B.5.3.2	Town/ city	Hørshom
B.5.3.3	Post code	2970
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+45NA45748147
B.5.5	Fax number	+45NA45748696
B.5.6	E-mail	MWRDK@alk.net

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	SLIToneULTRA HDM Mix 50 SRUs
D.3.4	Pharmaceutical form	Oral solution in single-dose container
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	DERMATOPHAGOIDES PTERONYSSINUS
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS
D.3.9.4	EV Substance Code	SUB25740
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DERMATOPHAGOIDES FARINAE
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES FARINAE
D.3.9.4	EV Substance Code	SUB29199
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
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	SLIToneUltra HDM Mix 150 SRUs
D.3.4	Pharmaceutical form	Oral solution in single-dose container
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	DERMATOPHAGOIDES PTERONYSSINUS
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS
D.3.9.4	EV Substance Code	SUB25740
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DERMATOPHAGOIDES FARINAE
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES FARINAE
D.3.9.4	EV Substance Code	SUB29199
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
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	SLIToneUltra HDM Mix 300 SRUs
D.3.4	Pharmaceutical form	Oral solution in single-dose container
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	DERMATOPHAGOIDES PTERONYSSINUS
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS
D.3.9.4	EV Substance Code	SUB25740
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DERMATOPHAGOIDES FARINAE
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES FARINAE
D.3.9.4	EV Substance Code	SUB29199
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
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 induced by house dust mites (HDM)

Rinitis alérgica inducida por ácaros del polvo doméstico

E.1.1.1

Medical condition in easily understood language

Allergic rhinitis induced by house dust mites (HDM)

Rinitis alérgica inducida por ácaros del polvo doméstico

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10001723
E.1.2	Term	Allergic rhinitis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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 evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLIToneULTRA house dust mite (HDM) mix in adult subjects with moderate to severe HDM allergic rhinitis.

Evaluar la relación dosis-respuesta con respecto a los cambios en los parámetros inmunológicos y la seguridad de SLIToneULTRA Dermatophagoides mezcla en adultos con rinitis alérgica moderada o severa inducida por ácaros del polvo doméstico.

E.2.2

Secondary objectives of the trial

To evaluate the tolerability of SLIToneULTRA HDM mix. The evaluation is based on the number of adverse events observed in the trial.

Evaluar la tolerabilidad de SLIToneULTRA Dermatophagoides mezcla. La evaluación se basará en el número de acontecimientos adversos observados
en el ensayo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written Informed consent before entering the trial
2. Male or female, aged 18 or older
3. A documented clinical relevant history of moderate to severe persistent HDM allergic rhinitis with or without asthma of at least one year prior to trial entry, with allergic rhinitis symptoms despite having received symptomatic medication
4. Moderate to severe HDM allergic rhinitis symptoms during the baseline period defined as a daily rhinitis symptom score of at least 6, or a score of 5 with one symptom being severe on the worst day in the 7-days baseline period
5. Positive skin prick test response (wheal diameter >= 3 mm) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
6. Positive specific IgE against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae (>= IgE Class 2, >= 0.70 kU/l).
7. Subject is one of the following: Male or Female, infertile or Female, with a negative pregnancy test and willingness to practice appropriate contraceptive methods until treatment with IMP has been discontinued.
8. Subject willing and able to comply with the trial protocol.

1. Obtención del consentimiento informado por escrito antes de la inclusión en el ensayo.
2. Varones o mujeres de 18 años de edad o superior.
3. Historia médica clínicamente relevante de rinitis moderada o persistente inducida por ácaros del polvo con o sin asma desde al menos 1 año antes de la inclusión en el ensayo, con síntomas de rinitis a pesar de haber recibido medicación sintomática.
4. Síntomas de rinitis alérgica moderada o severa inducida por ácaros del polvo durante el periodo basal definido como una puntuación de síntomas de rinitis de al menos 6, o de 5 si uno de los síntomas es severos en el peor día de los 7 del periodo basal.
5. SPT positivo (diámetro de pápula >= 3 mm) a Dermatophagoides pteronyssinus y/o D. farinae.
6. IgE específica positiva frente a Dermatophagoides pteronyssinus y/o D. farinae (>= IgE clase 2; >= 0,70 KU/l).
7. Los sujetos deben ser, bien: Hombres o Mujeres no fértiles o Mujeres con un test de embarazo negativo y que quieran cumplir con los métodos anticonceptivos apropiados hasta que finalice el tratamiento con el IMP.
8. Sujetos dispuestos a cumplir con el protocolo.

E.4

Principal exclusion criteria

1. Previous treatment with immunotherapy with Dermatophagoides pteronyssinus and/or Dermatophagoides farinae or a cross-reacting allergen within the last 5 years
2. Ongoing treatment with any allergen specific immunotherapy product
3. Reduced lung function (defined as FEV1 < 70% of predicted value after adequate pharmacologic treatment)
4. Clinical history of uncontrolled asthma within 3 months prior to the screening visit
5. 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 subject)
6. Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease)

1. Tratamiento previo con inmunoterapia con Dermatophagoides pteronyssinus y/o D. farinae o con algún alérgeno con reactividad cruzada en los 5 últimos años.
2. Tratamiento concomitante con inmunoterapia específica con cualquier alérgeno.
3. Función pulmonar reducida (definida como FEV1 < 70% del valor teórico tras un tratamiento farmacológico adecuado).
4. Historia médica de asma no controlado en los 3 meses previos a la visita de selección.
5. Cualquier enfermedad crónica relevante (> 3 meses de duración) (p.e. fibrosis quística, cáncer, malabsorción o malnutrición, anormalidad renal o hepática o cualquier otra enfermedad que en opinión del investigador pudierainterferir con las evaluaciones del ensayo o la seguridad del sujeto).
6. Enfermedad sistémica que afecte al sistema inmunológico (p.e. enfermedad autoinmune, enfermedad de complejo inmue, o inmunodeficiencia).

E.5 End points

E.5.1

Primary end point(s)

Pre-to-post treatment change in specific IgE-blocking factor to Dermatophagoides pteronysinus

Cambio pre-post tratamiento en el factor bloqueante de la IgE a
Dermatophagoides pteronyssinus.

E.5.1.1

Timepoint(s) of evaluation of this end point

After 6 months of treatment

Tras 6 meses de tratamiento

E.5.2

Secondary end point(s)

Pre-to-post treatment change in specific IgE-blocking factor to
Dermatophagoides farinae
Pre-to-post treatment change in IgG4 to Dermatophagoides
pteronysinus and Dermatophagoides farinae
Pre-to-post treatment change in specific IgE to Dermatophagoides
pteronysinus and Dermatophagoides farinae
Adverse Events and Serious Adverse Events

Cambio pre-post tratamiento en el factor bloqueante de la IgE a Dermatophagoides farinae.
Cambio pre-post tratamiento en la IgG4 a Dermatophagoides
pteronyssinus y Dermatophagoides farinae.
Cambio pre-post tratamiento en la IgE a Dermatophagoides
pteronyssinus y Dermatophagoides farinae.
Acontecimientos adversos y acontecimientos adversos
graves.

E.5.2.1

Timepoint(s) of evaluation of this end point

After 6 months of treatment

Tras 6 meses de 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

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

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

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

SLITone ULTRA Dermatophagoides mezcla 50 vs 150 vs 300

SLITone ULTRA MIX HDM 50 vs 150 vs 300

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

The trial end is defined in the protocol as the database closure.

El final del ensayo se define en el protocolo como el cierre de la base de datos.

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:

210

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

210

F.4.2.2

In the whole clinical trial

210

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-11-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-10-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-09-04

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