Clinical Trials Register

Summary
EudraCT Number:	2016-000076-23
Sponsor's Protocol Code Number:	AN006T-ATIBAR
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-05-17
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

Germany - PEI

A.2

EudraCT number

2016-000076-23

A.3

Full title of the trial

A MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL TO ASSESS THE EFFICACY AND TOLERABILITY OF TWO DOSING REGIMENS OF ALLERT, A COMBINATION OF CONTIGUOUS OVERLAPPING PEPTIDES DERIVED FROM BET V 1, IN ADULTS WITH BIRCH POLLEN ALLERGIC RHINITIS/RHINOCONJUNCTIVITIS

A.3.1

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

A clinical study to determine the efficacy and tolerability of two doses of AllerT for reducing allergy symptoms for patients with Birch allergy.

A.4.1

Sponsor's protocol code number

AN006T-ATIBAR

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	ANERGIS SA
B.1.3.4	Country	Switzerland
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	ANERGIS SA
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ANERGIS SA
B.5.2	Functional name of contact point	Chief Development Officer
B.5.3	Address:
B.5.3.1	Street Address	Biopôle III, Route de la Corniche 9B
B.5.3.2	Town/ city	EPALINGES
B.5.3.3	Post code	CH 1066
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41 21 651 92 41
B.5.5	Fax number	+41 21 651 92 21
B.5.6	E-mail	Kim.Simonsen@anergis.ch

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	AllerT
D.3.4	Pharmaceutical form	Powder for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not established
D.3.9.1	CAS number	none
D.3.9.2	Current sponsor code	AllerT1
D.3.9.3	Other descriptive name	AllerT1
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	17.15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not established
D.3.9.1	CAS number	none
D.3.9.2	Current sponsor code	AllerT2
D.3.9.3	Other descriptive name	AllerT2
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	25.55
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not established
D.3.9.1	CAS number	none
D.3.9.2	Current sponsor code	AllerT3
D.3.9.3	Other descriptive name	AllerT3
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	19.80
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	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	AllerT
D.3.4	Pharmaceutical form	Powder for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not established
D.3.9.1	CAS number	none
D.3.9.2	Current sponsor code	AllerT1
D.3.9.3	Other descriptive name	AllerT1
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	3.43
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not established
D.3.9.1	CAS number	none
D.3.9.2	Current sponsor code	AllerT2
D.3.9.3	Other descriptive name	AllerT2
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	5.11
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not established
D.3.9.1	CAS number	none
D.3.9.2	Current sponsor code	AllerT3
D.3.9.3	Other descriptive name	AllerT3
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	3.96
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.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	Powder for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Adult patients, 18-65 years of age, suffering from moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons.

E.1.1.1

Medical condition in easily understood language

birch pollen induced allergy

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	10066093
E.1.2	Term	Birch pollen allergy
E.1.2	System Organ Class	100000023864

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 demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 50 μg maintenance dose compared to placebo in reducing symptoms of and medication use in allergic Rhinitis/Rhinoconjunctivitis during the following birch pollen season

E.2.2

Secondary objectives of the trial

To demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 10 μg maintenance dose in reducing symptoms of and medication use in allergic Rhinitis/Rhinoconjunctivitis during the following birch pollen season

To evaluate the safety and tolerability of a two months pre-seasonal treatment with AllerT at maintenance doses of 50 μg and of 10 μg

To evaluate the effects of a two months pre-seasonal treatment with AllerT at maintenance doses of 50 μg and 10 μg during the following birch pollen season on:
o Subjects' quality of life
o Other clinical endpoints including night-time symptoms, number of well days, number of days with severe symptoms and subject’s global evaluation of treatment efficacy

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men or women aged 18 to 65 years
2. Subjects presenting moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen confirmed at screening by all of the following criteria:
a. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two consecutive preceding birch pollen seasons based on subject’s interview by the investigator
b. Previous use of anti-allergy medications during the two preceding birch pollen seasons based on subject’s interview by the investigator
c. Positive SPT to birch pollen extract (wheal ≥ 5 mm larger than the diluent control)
d. Positive specific IgE CAP test for Bet v 1 (≥ 3 kU/L)
3. Women of childbearing potential under continuous effective contraception during the treatment period
a. This includes: established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; true abstinence (periodic abstinence and withdrawal are not acceptable) or vasectomised male partner, provided that he is the sole partner of that subject.
4. Subjects having been informed and having provided signed consent for participating in the trial and willing to follow all planned trial assessments
Included subjects must not be entered more than once into the trial.

E.4

Principal exclusion criteria

1. Received specific immunotherapy against:
a. Any allergen within five (5) years before the screening visit
b. Birch pollen or a tree pollen mix including birch pollen at any time before the screening visit
2. Clinical symptoms due to allergens other than birch pollen during the expected birch pollen season (e.g. perennial allergies, allergies to other pollens with a season overlapping the birch pollen season). Patients sensitized to alder and/or hazel may be included provided that the clinical symptoms is caused by their birch allergy.
3. Persistent non-controlled asthma; subjects with a Forced Expiratory Volume (FEV1) lower than 85% of predicted value (see FEV1 predicted and 85% of predicted values in Appendix 12.3) and/or subjects under chronic treatment for asthma. Subjects with seasonal asthma may be included if they are controlled with beta-2-agonist and low dose inhaled corticosteroid (below or equal to budesonide 400 micro-gram on a daily basis).
4. History of severe anaphylactic reaction (grade 4 reaction as per the definitions given in Appendix 12.1)
5. History of any debilitating disease and/or severe medical condition able to influence the course of the trial or the ability of the subjects to fulfill the requirements of the trial
6. Any confirmed or suspected primary or secondary immunodeficiency condition, including human immunodeficiency virus (HIV) infection and asplenia
7. Pregnant or lactating women or women willing or intending to become pregnant during the trial
8. Suspected or known current alcohol or any drug abuse
9. Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the trial
10. Subjects intending to travel during the birch pollen season outside of the birch pollination area for more than seven consecutive days
11. Subjects unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
12. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
13. Beta-blockers or ACE-inhibitors within four weeks prior to randomization, or planned to be used during the treatment period
14. Immunosuppressive medication (including steroids) within four weeks prior to randomization, or planned to be used during the trial period
15. Use of anti-depressant medication with antihistamine effect within two weeks prior to randomization
16. Use of any investigational or non-registered drug, vaccine or medical device within four weeks prior to randomization, or planned to be used during the trial period

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variable is the average of the combined Rhinoconjunctivitis Symptom and Medication Score (CSMS) obtained daily during the birch pollen season.

E.5.1.1

Timepoint(s) of evaluation of this end point

Start day of birch pollen season until end day of birch pollen season.

E.5.2

Secondary end point(s)

Average of the total score of the quality of life questionnaires obtained weekly during the birch pollen season using the validated Mini-RQLQ questionnaire
Average of the Night-time Nasal Symptom Score (NNSS) obtained daily during the birch pollen season
Average of the combined Rhinoconjunctivitis and Night-time Symptom and Medication Score (CNSMS) obtained daily during the birch pollen season
Percent of Well Days during the birch pollen season
Percent of Days with Severe Symptoms during the birch pollen season
Subject’s global evaluation of treatment efficacy collected at the end of the birch pollen season both on a categorical scale as well as on a VAS

E.5.2.1

Timepoint(s) of evaluation of this end point

Start day of birch pollen season until end day of birch pollen season.

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

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

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

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

LVLS

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

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

450

F.4.2.2

In the whole clinical trial

450

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 subjects will be treated according to local standard practice.

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

2016-09-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-11-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-07-03

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