Clinical Trials Register

Summary
EudraCT Number:	2010-018621-19
Sponsor's Protocol Code Number:	MT-04
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-06-18
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

UK - MHRA

A.2

EudraCT number

2010-018621-19

A.3

Full title of the trial

Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma.

A.3.2

Name or abbreviated title of the trial where available

The MITRA trial.

A.4.1

Sponsor's protocol code number

MT-04

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ALK-Abello 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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Allergy Immunotherapy Tablet
D.3.2	Product code	AIT
D.3.4	Pharmaceutical form	Oral lyophilisate
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.2	Current sponsor code	Der pte
D.3.9.3	Other descriptive name	Allergen extract from Dermatophagoides pteronyssinus
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.2	Current sponsor code	Der far.
D.3.9.3	Other descriptive name	Allergen extract from Dermatophagoides farinae
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Allergy Immunotherapy Tablet
D.3.2	Product code	AIT
D.3.4	Pharmaceutical form	Oral lyophilisate
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.2	Current sponsor code	Der pte
D.3.9.3	Other descriptive name	Allergen extract from Dermatophagoides pteronyssinus
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.2	Current sponsor code	Der far.
D.3.9.3	Other descriptive name	Allergen extract from Dermatophagoides farinae
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Oral lyophilisate
D.8.4	Route of administration of the placebo	Oromucosal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

House dust mite induced asthma

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10001705
E.1.2	Term	Allergic asthma

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 the trial is to evaluate the efficacy of the the house dust mite Allergy Immunotherapy Tablet (6 DU and 12 DU) given once daily compared to placebo in subjects with house dust mite induced asthma, as measured by reducing the risk for an asthma exacerbation.

E.2.2

Secondary objectives of the trial

The key secondary objectives of the trial are to determine the effects of the house dust mite Allergy Immunotherapy Tablet on asthma symptoms and immunology.

Other secondary objectives include evaluating the effects of the house dust mite Allergy Immunotherapy Tablet on lung function, asthma control, safety, symptomatic medication, asthma quality of life, and pharmacoeconomics.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects who meet each of the following criteria are eligible for the trial:

1. Written informed consent obtained before entering the trial.
2. Male or female ≥ 18 years.
3. A clinical relevant history consistent with HDM induced asthma of at least 1 year prior to trial entry.
4. Use of asthma medication (e.g. combination products) for the control of asthma symptoms for a period of at least 6 months within the past year.
5. Dose of ICS after switching should at randomisation be in a range of budesonide 400-800 mcg.
6. Documented reversible airway obstruction as judged by one of the following criteria:
a) Improvement in absolute FEV1 ≥ 12% and 200 ml after administration of SABA.
b) Improvement in PEF > 20% after administration of SABA.
c) Diurnal variability in PEF > 20% after administration of SABA.
d) Bronchial provocation test:
1. A decrease in FEV1 > 15% after 6 min of sustained exercise.
2. A decrease in FEV1 ≥ 10% from baseline is recorded after a 6 minutes period of hyperpnea in dry air.
3. A decrease in FEV1 ≥ 15% from baseline or ≥ 10% from value obtained after the previous dose after mannitol inhalation challenge.
4. A decrease in FEV1 ≥ 20% from baseline after methacholine inhalation challenge.
7. Asthma control level above or equal to 1.0 (ACQ ≥ 1.0) at visit 1 (screening).
8. Asthma control level between 1.0 and 1.5 (1.0 ≤ ACQ ≤ 1.5) at visit 3 (randomisation).
9. Electronic diary compliance rate between visit 2 and visit 3 ≥ 80% at visit 3 (randomisation).
10. FEV1 > 60% of predicted value.
11. A clinical history consistent with mild to severe HDM induced allergic rhinitis for at least 1 year.
12. Positive SPT response (wheal diameter ≥ 3 mm larger than the negative control) to Der pte or Der far.
13. Positive specific IgE against Der pte or Der far (≥ IgE Class 2; ≥ 0.70 KU/L).
14. Female subjects, who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods throughout the trial.
15. Subject willing and able to comply with trial protocol regimens.

E.4

Principal exclusion criteria

Subjects who meet one or more of the following criteria are excluded from the trial:

1. A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except HDM).
2. A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period of the year corresponding the ICS reduction period (period 3).
3. Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years.
4. A clinical history of chronic sinusitis (> 3 months).
5. Hospitalisation for more than 12 hours due to asthma exacerbation within the last 3 months prior to screening visit.
6. Current or previous use of any medication as specified in the protocol.
7. Symptoms of or treatment for upper respiratory tract infection, or other relevant infectious process at randomisation.
8. Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomisation.
9. Physical examination with clinically relevant findings.
10. History of systemic allergic reaction with cardiorespiratory symptoms (e.g. food allergy, drugs or an idiopathic reaction).
11. History of recurrent urticaria during the last 2 years.
12. A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents or siblings) history of hereditary angioedema.
13. Any clinically relevant chronic disease (≥ 3 months duration) (e.g. cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency).
14. Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease).
15. Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit (except steroids for allergy and asthma symptoms).
16. History of allergy, hypersensitivity or intolerance to IMPs (except Der pte or Der far) or symptomatic medications.
17. Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the time to first moderate or severe asthma exacerbation during period 3 (inhaled glucocorticosteroid reduction).

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

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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.8.3

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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 end of the trial is the last visit of the last patient.

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.1.3

Elderly (>=65 years)

Yes

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.4.2

For a multinational trial

F.4.2.1

In the EEA

750

F.4.2.2

In the whole clinical trial

800

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)

Following participation in the trial, subjects will revert to their normal standard of care.

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

2010-07-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-09-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-06-25

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