Clinical Trials Register

Summary
EudraCT Number:	2014-004223-46
Sponsor's Protocol Code Number:	SL75.14
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-07-16
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2014-004223-46

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, multi-center study of the efficacy and safety of STG320 sublingual tablets of house dust mite (HDM) allergen extracts in adults and adolescents with HDM-associated allergic rhinitis

A.3.1

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

Efficacy and safety study evaluating a new sublingual treatment in HDM allergic rhinitis

A.4.1

Sponsor's protocol code number

SL75.14

A.5.4

Other Identifiers

Name:

16252

Number:

IND Number

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	STALLERGENES
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	STALLERGENES
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	STALLERGENES
B.5.2	Functional name of contact point	Senior Medical Director
B.5.3	Address:
B.5.3.1	Street Address	6 rue Alexis de Tocqueville
B.5.3.2	Town/ city	Antony
B.5.3.3	Post code	92160
B.5.3.4	Country	France
B.5.4	Telephone number	0033155592556
B.5.5	Fax number	0033155592068
B.5.6	E-mail	martine.legall@stallergenesgreer.com

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	Yes
D.2.1.1.2	Name of the Marketing Authorisation holder	Shionogi Co., Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Japan
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	House dust mite allergen extracts
D.3.2	Product code	STG320
D.3.4	Pharmaceutical form	Sublingual tablet
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 allergen extract
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
D.3.9.4	EV Substance Code	SUB84531
D.3.10	Strength
D.3.10.1	Concentration unit	BAU Bioequivalent Allergy Unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dermatophagoides farinae allergen extract
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES FARINAE EXTRACT
D.3.9.4	EV Substance Code	SUB84530
D.3.10	Strength
D.3.10.1	Concentration unit	BAU Bioequivalent Allergy Unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	Yes
D.2.1.1.2	Name of the Marketing Authorisation holder	Shionogi Co., Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Japan
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	House dust mite allergen extracts
D.3.2	Product code	STG320
D.3.4	Pharmaceutical form	Sublingual tablet
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 allergen extract
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
D.3.9.4	EV Substance Code	SUB84531
D.3.10	Strength
D.3.10.1	Concentration unit	BAU Bioequivalent Allergy Unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dermatophagoides farinae allergen extract
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES FARINAE EXTRACT
D.3.9.4	EV Substance Code	SUB84530
D.3.10	Strength
D.3.10.1	Concentration unit	BAU Bioequivalent Allergy Unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	Sublingual tablet
D.8.4	Route of administration of the placebo	Sublingual 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 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

E.1.1.1

Medical condition in easily understood language

Allergic rhinitis due to house dust mite

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10001725
E.1.2	Term	Allergic rhinitis due to other allergen
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

To evaluate the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated allergic rhinitis.

E.2.2

Secondary objectives of the trial

- To assess the efficacy of STG320 sublingual tablets at dosage of 300 IR
- Rhinoconjunctivitis symptom evaluation and rescue medication use will also be evaluated during the 2-week secondary evalutation period
- To assess the effect of STG320 on other variables at the end of treatment (work productivity and activity impairment, immunological markers)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have house dust mite (HDM)-associated allergic rhinitis (AR) (with or without asthma) for at least 1 year based on the presence of:
• Symptoms for 4 or more consecutive weeks in the previous year and for at least 4 days per week during those weeks.
• Symptoms requiring regular intake of symptomatic treatment(s).
• Symptoms evaluated as “troublesome” by the patients or impairing their daily activities, leisure or sport, school or work or involving sleep disturbance.
2. Have given signed informed consent to participate, after having been informed of the nature and aims of the study, in accordance with local regulation and requirements.
3. Male or female outpatients 12 to 65 years of age.
4. Sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined as skin prick test wheal diameter at least 5 mm greater than the negative control and HDM-specific serum IgE ≥3.5 kU/L.
5. Willing to and capable of completing the e-diary, study questionnaires and scales.

E.4

Principal exclusion criteria

1. A history of rhinitis, rhino-conjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the baseline and primary evaluation periods
Specifically, when the following are present:
• documented sensitization (positive Skin Prick Test or allergen specific serum IgE >3.5kU/L) and history of clinically relevant symptoms to allergen(s) other than HDM
• anticipated exposure to such allergen(s) during the baseline and primary evaluation periods
For example, the following patients are to be excluded:
- patients sensitized to cat or dog allergens and regularly exposed to these animals
- patients sensitized to perennial allergens, such as aspergillus, cladosporium, alternaria, cockroach
- patients sensitized to seasonal allergens such as parietaria, ragweed or mugwort, if these allergens are endemic in the region during the baseline and primary evaluation periods.
2. Any diagnosed nasal (other than HDM allergic rhinitis) or oral disease that could interfere with the efficacy or safety assessments, such as nasal polyposis, recurrent chronic rhino-sinusitis (at least 2 isolated episodes per year in the 2 previous years, each episode lasting more than 8 weeks) or a history of chronic oral inflammation or current active oral inflammation from any etiology (e.g., oral lichen planus, oral ulceration or oral mycosis) and/or oral wounds.
3. Recent nasal surgery (i.e., within the previous 6 months).
4. Partially controlled or uncontrolled asthma defined in the Global Initiative for Asthma 2014 guidelines (GINA 2014) as the presence of daytime asthma symptoms more than twice/week or nocturnal symptoms/awakening or need for reliever/rescue treatment more than twice/week or FEV1 <80% of predicted or personal best value.
5. Asthma therapies consistent with GINA treatment Step 3, Step 4 and Step 5 i.e., the preferred controller medication consists of inhaled corticosteroid (ICS) combined with long-acting beta (β)-2 agonist (LABA) according to GINA classification 2014 (refer to Appendix II for the full details of other controller options).
6. Experienced a life-threatening asthma attack or an asthma exacerbation that resulted in Intensive Care Unit (ICU) hospitalization.
7. Requiring continuous treatment with systemic corticosteroids for any indication.
8. Requiring continuous treatment with β-blockers or with Monoamine Oxidase Inhibitors (MAOIs).
9. Received an immunosuppressive treatment within 3 months prior to screening.
10. Received allergen specific immunotherapy (AIT) by any route:
- for house dust mites: AIT for more than 1 month within the 5 years before screening
- for other allergen(s): ongoing or recently stopped (within 6 months) AIT.
11. Any history of anaphylaxis after previous allergen immunotherapy, exposure to allergen(s) or of unknown cause.
12. Any history of hypersensitivity to STG320 or its excipients or contraindication to the use of rescue medications
13. Female with positive urine pregnancy test or lactating or expecting to conceive within the duration of the study.
14. Sexually active female of child-bearing potential without medically accepted contraceptive method
15. Unable or unwilling to comply with the study protocol requirements, including those who anticipate significant changes in their daily environment in relation to HDM exposure or who are likely to travel for extended periods of time during the main efficacy assessment period.
16. Patients with past or current disease(s) 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, active tuberculosis, hepatic disease, renal disease, hematologic disease, neurologic or psychiatric disease, severe autoimmune disorder, immunodeficiency or immunologic disease and endocrine disease.
17. Patients with a history of eosinophilic esophagitis or with current severe or persistent gastroesophageal symptoms including dysphagia or chest pain.
18. Contraindications to allergen specific immunotherapy.
19. Patients with history of drug or alcohol abuse.
20. Participation in any clinical study within 30 days prior to the selection visit.
21. Possible dependency of the patient on sponsor or investigators/subinvestigators or study personnel.

E.5 End points

E.5.1

Primary end point(s)

Total Combined Score (TCS). The average TCS is calculated for each patient as the average of the non-missing daily TCSs.
The daily TCS (scale 0-15) is the sum of the patient’s daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3).

E.5.1.1

Timepoint(s) of evaluation of this end point

All along the study

E.5.2

Secondary end point(s)

Rhinitis Total Symptom Score (RTSS)
Rescue Medication Score (RMS)
Adjusted Symptom Score (ASS, scale 0-12)
Total Ocular Symptom Score (TOSS, scale 0-6)
Six Individual Rhinoconjunctivitis Symptom Scores (RSSs)
Rhinoconjunctivitis rescue medication usage
Visual Analogue Scale (VAS)
Proportion of Symptom-Controlled Days (PSCD)
Controlled patients (CP)
Overall Standardized Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)≥12) scores
EQ-5D-5L Generic health-related quality of life questionnaire
Global Rating of Change Score (GRCS)

E.5.2.1

Timepoint(s) of evaluation of this end point

All along the study

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

125

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

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

Belgium

Bulgaria

Canada

Czech Republic

France

Germany

Israel

Italy

Poland

Russian Federation

Slovakia

Spain

United States

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

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

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:

200

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:

200

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1540

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1100

F.4.2.2

In the whole clinical trial

1740

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

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-09-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-08-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-06-21

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