Clinical Trials Register

Summary
EudraCT Number:	2007-001454-77
Sponsor's Protocol Code Number:	VO57.07
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-06-14
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

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2007-001454-77

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled, multi-national Phase II/III study of the safety and efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adult patients suffering from house dust mite allergic rhinitis

A.4.1

Sponsor's protocol code number

VO57.07

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	Stallergenes S.A
B.1.3.4	Country	France
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	Allergen extract of house dust mites
D.3.2	Product code	Dermatophagoides pteronyssinus allergen extract
D.3.4	Pharmaceutical form	Sublingual tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Dermatophagoides pteronyssinus allergen extract
D.3.9.3	Other descriptive name	Allergen extract of house dust mite
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50IR
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Dermatophagoides Farinae Allergan Extract
D.3.9.3	Other descriptive name	Allergen extract of house dust mite
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50IR
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	Information not present in EudraCT
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	Allergen extract of house dust mites
D.3.2	Product code	Dermatophagoides pteronyssinus allergen extract
D.3.4	Pharmaceutical form	Sublingual tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Dermatophagoides pteronyssinus allergen extract
D.3.9.3	Other descriptive name	Alergen extract of house dust mite
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150IR
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Dermatophagoides Farinae Allergan Extract
D.3.9.3	Other descriptive name	Allergen extract of house dust mite
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150IR
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	Information not present in EudraCT

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	Sublingual tablet
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

House dust mite allergic rhinitis

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10001723
E.1.2	Term	Allergic rhinitis

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 assess the efficacy of 12 months of SLIT on the Average Rhinitis Total Symptom Score (ARTSS) of the four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion

To document the safety of 12 months of SLIT as well as the safety of a further 12 months treatment free follow-up.

E.2.2

Secondary objectives of the trial

Secondary Efficacy:
To assess the efficacy of 12 months of SLIT on the:
Average Rescue Medication Score (ARMS) (antihistamine [oral and eye drops], nasal corticosteroids and oral corticosteroids).
Average Combined Score (ACS) – a score taking into account the Rhinitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS).
Five individual Average Symptom Scores (ASS) (sneezing, rhinorrhoea, nasal pruritus, nasal congestion and ocular itching).
Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score.
Global evaluation of the efficacy of SLIT by the patient.
Skin prick test (SPT) specific for house dust mites (D. pteronyssinus and D. farinae).
Immunological markers (immunoglobulin IgE and IgG4) specific for house dust mite allergens.
Asthma assessments.
Sensitisation (mono-sensitivity to house dust mites only or poly-sensitivity [other allergens]).
Onset of action of SLIT.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Diagnosis and Criteria for Inclusion:
Inclusion criteria:
1. Male or female outpatients aged 18 to 50 years (inclusive).
2. Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
3. Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.
4. Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
5. Negative urine pregnancy test on female patients of childbearing potential.
6. House dust mite-related allergic rhinitis for at least 1 year.
7. Sensitised to D. pteronyssinus or D. farinae (positive SPT with wheal diameter greater than 3 mm and a specific IgE level ≥ 0.7 kU/L).
8. Baseline ARTSS ≥5 (after completion of the 7-day daily record card).
9. Patients who are willing to comply with the protocol.
10. Patients who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card and the RQLQ.

E.4

Principal exclusion criteria

Exclusion Criteria:
1. Whatever the considered allergens, co-sensitisation leading to clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites).
2. Patients with any nasal condition that could confound the efficacy or safety assessments (for example nasal polyposis).
3. Patients sensitised to cat or dog allergens and living with these animals at home.
4. Pregnant, breast-feeding / lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
5. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included (corresponding to the Global Initiative for Asthma [GINA] Step 1).
6. Patients treated with systemic, nasal or inhaled steroids (whatever the indication) within 4 weeks before Visit 1.
7. Patients treated with long acting systemic steroids (whatever the indication) within 12 weeks before Visit 1 and before Visit 2.
8. FEV1 < 80% of predicted value at Visit 1.
9. Patients who received allergy specific immunotherapy for house dust mites in the last 10 years.
10. Patients at risk of non-compliance.
11. Participation in any clinical study within the 12 weeks before Visit 1.
12. Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
13. Any change in environmental measures for allergen avoidance during the study.
14. Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
15. Patients treated with beta-blockers or under continuous corticotherapy.
16. Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies.
17. Ongoing treatment by immunotherapy with another allergen.
18. Patients with a history of drug or alcohol abuse.

E.5 End points

E.5.1

Primary end point(s)

Criteria for Evaluation:
Primary Efficacy Variable:
The primary efficacy variable will be the ARTSS at endpoint, with endpoint defined as the rhinitis symptom data collected between Visit 8 and Visit 9 during the Treatment Phase.
• The RTSS is defined as the sum of the sneezing, rhinorrhoea, nasal pruritus and nasal congestion scores as evaluated by the patient, using a score from 0 to 3:
0 = Absent symptoms (no sign / symptom evident).
1 = Mild symptoms (sign / symptom clearly present, but minimal awareness; easily tolerated).
2 = Moderate symptoms (definite awareness of sign / symptom that is bothersome but tolerable).
3 = Severe symptoms (sign / symptom that is hard to tolerate; causes interference with activities of daily living and / or sleeping).
• The daily ARTSS will be calculated for each visit period (average of the available and valid daily data) for 1 week after Visit 1 (4 valid days of data are needed in the 7-day period) and each of the 2 weeks after Visit 4, Visit 5, Visit 6 and Visit 7, as well as the average of the available and valid daily data for the 2 months between Visit 8 and Visit 9. The same principle will apply to Visit 11 to Visit 14. Data for a given day is valid if the four symptom scores (sneezing, rhinorrhoea, nasal pruritus and nasal congestion) have been recorded appropriately. At least 1 day of data (unless otherwise specified) needs to be valid in a given visit period for the ARTSS to be calculated for the visit period in question.
• If no valid data for a given visit period is available, the last observation carried forward (LOCF) approach will be used, if appropriate, to impute the ARTSS, that is, the ARTSS from the previous visit period or the baseline ARTSS if the previous visit period ARTSS is not available, will be used.

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

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

Information not present in EudraCT

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)

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-06-14.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	60
F.4.2	For a multinational trial
F.4.2.1	In the EEA	486
F.4.2.2	In the whole clinical trial	486

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

2007-08-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-09-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-02-03

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