Clinical Trials Register

Summary
EudraCT Number:	2015-004551-43
Sponsor's Protocol Code Number:	CS-BM32-004
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-11-04
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

Austria - BASG

A.2

EudraCT number

2015-004551-43

A.3

Full title of the trial

Study to evaluate the effect of different pre-seasonal BM32 dosing schedules on the induction of a protective allergen-specific IgG Immune response

A.3.1

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

Study to evaluate the effect of different pre-seasonal BM32 dosing schedules on the induction of a protective allergen-specific IgG Immune response

A.4.1

Sponsor's protocol code number

CS-BM32-004

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	Biomay AG
B.1.3.4	Country	Austria
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	Biomay AG
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Biomay AG
B.5.2	Functional name of contact point	Product Development Department
B.5.3	Address:
B.5.3.1	Street Address	Lazarettgasse 19/1
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	A-1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	004317966296101
B.5.6	E-mail	a.neubauer@biomay.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	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.3.2	Product code	BM32
D.3.4	Pharmaceutical form	Suspension 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	BM321
D.3.9.2	Current sponsor code	BM321
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BM322
D.3.9.2	Current sponsor code	BM322
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BM325
D.3.9.2	Current sponsor code	BM325
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BM326
D.3.9.2	Current sponsor code	BM326
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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)	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	Yes
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.2.1.1.1	Trade name	Physiologische Kochsalzlösung Fresenius
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Austria GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	Physiologische Kochsalzlösung Fresenius
D.3.4	Pharmaceutical form	Solution 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	Sodium Chloride
D.3.9.3	Other descriptive name	NaCl
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.9
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	Suspension 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

Grass pollen allergy

E.1.1.1

Medical condition in easily understood language

Grass pollen allergy

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

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 level of allergen-specific IgG4 and IgG1 antibodies at the peak of the grass pollen season comparing the different dosing schedules of BM32 at the dose of 20µg per API with placebo.

E.2.2

Secondary objectives of the trial

• effects of different dosing schedules of BM32 (at a dose of 20µg per API) compared to placebo by studying the grass pollen-specific Total Nasal Symptom Score (TNSS) of grass pollen-induced allergic rhinitis provoked by spending 6 hours in the VCC before the treatment, and at Visit 9.
• effect of treatment with different dosing schedules of BM32 on the Symptom-Scores (SS), Medication-Scores (MS) and Combined Symptom/Medication Scores (SMS) recorded in the Patient Diary during the peak of the grass pollen season.
• Effect of treatment with BM32 dosing schedules on the “Well-being” of subjects during the grass pollen season as measured via a visual analogue score (VAS) recorded in the Patient Diary.
• Development of immunological parameters during the study by measuring grass pollen allergen-specific IgG, IgG1, IgG4 in serum samples collected from subjects at different time points.
• Relative safety and tolerability of the different BM32 dosing schedules vs. placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• The subjects are grass pollen allergic but otherwise healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
• They are aged 18 to 60 years inclusive.
• They have a history of seasonal allergic rhinitis (SAR) to grass pollen.
• They have a normal electrocardiogram without clinically significant abnormalities.
• They exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as a nasal symptom score (TNSS) of at least 6. (Nasal symptom score is the sum of nasal obstruction, rhinorrhea, itchy nose and sneezing, each of which have been scored on a categorical scale from 0 to 3 as given in Appendix II).
• They have a positive skin prick test with a wheal diameter over 4mm for grass pollen extract at the screening visit.
• They have a positive serum IgE test for timothy grass pollen and to rPhl p 1+rPhl p 5 at the screening visit or within the previous six months (timothy grass (g6): ImmunoCAP IgE level
≥ 3.5 kUA/l ; rPhl p 1/rPhl p 5 (g213): ImmunoCAP IgE level
≥ 2.0 kUA/l)
• There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours.
• They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
• They are available to complete all study measurements

E.4

Principal exclusion criteria

• Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test).
• They have a positive serum IgE test for rPhl p 7 at the screening visit or within the previous six months (ImmunoCAP IgE level ≥0,35 kUA/l)
• They have a positive skin prick test for alternaria and this is confirmed by their ISAC sensitization profile
• On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study.
• Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists or low-dose inhaled corticosteroid and associated with normal lung function.
• The subject is concurrently participating or has participated in any clinical study in the previous month. However, participation solely in the form of blood donation and/or without other interventions will be acceptable.
• Participation in a SIT trial for grass pollen allergy in the three years prior to this study.
• Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
• Documented autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies as judged by the investigator
• Suspected hypersensitivity to any ingredients of the study medication
• Use of prohibited medication:
o Depot corticosteroids – 12 weeks prior to Visit 1
o Oral corticosteroids – 8 weeks prior to Visit 1
o long-acting inhaled corticosteroids – 4 weeks
prior to Visit 1
o depot corticosteroids or long-acting inhaled corticosteroids throughout the study
o anti-histamines (histamine H1 blockers) three days prior to pollen chamber sessions
• The subject is at risk of non-compliance with the study procedures/restrictions.
• Allergic symptoms at the time of screening

E.5 End points

E.5.1

Primary end point(s)

• Level of allergen-specific IgG4 antibodies at the peak of the grass pollen season
(Visit 8) comparing the sum of IgG levels against Phl p 1 + Phl p 5 of each BM32 group vs. placebo.
• Level of allergen-specific IgG1 antibodies at the peak of the grass pollen season
(Visit 8) comparing the sum of IgG levels against Phl p 1 + Phl p 5 of each BM32 group vs. placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 3 (baseline levels, before treatment)
Visit 8 (at the peak of the grass pollen season)

E.5.2

Secondary end point(s)

• Difference in the total Nasal Symptom Score (TNSS) (nasal obstruction, rhinorrhea, itchy nose and sneezing) between spending 6 hours in the VCC at Visit 2 and spending 6 hours in the VCC at Visit 9.
• The mean daily Symptom-Score (SS), Medication-Score (MS), and Combined Symptom-/ Medication Score (SMS) measured during the grass pollen season and the peak of the grass pollen season.
• Mean level of “well-being” during the grass pollen season of patients receiving BM32 compared to placebo based on daily records on a visual analogue score (VAS)
• Mean allergen-specific antibodies (IgG. IgG1, IgG4) as measured at different time points during the study (Visits 1,3,4,5,6,7,8, 9, 10, and 11) compared between verum treated and placebo treated patients.
• Frequency of AEs concerning occurrence, seriousness, intensity and relationship to study drug.
• Frequency and grading of SIT-specific local and systemic reactions.
• Lung function (FEV1), blood pressure, pulse rate, body temperature, and breathing frequency at screening, and throughout the study
• Findings of physical examination at screening, and at the follow-up Visit

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy endpoints will be evaluated during the peak of the grass pollen season or after the grass pollen season (visit 9) respectively.
Immunogenicity endpoints and safety endpoints will be evaluated throughout 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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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 end of trial is defined as "data base lock".

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

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:

140

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

140

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-01-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-11-17

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