Clinical Trials Register

Summary
EudraCT Number:	2020-000408-13
Sponsor's Protocol Code Number:	PQGrass309
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:	2020-04-28
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

Germany - PEI

A.2

EudraCT number

2020-000408-13

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled exploratory study to explore the efficacy and safety of PQ Grass 27600 SU in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure

A.3.1

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

An exploratory study of PQ Grass 27600 SU

A.3.2

Name or abbreviated title of the trial where available

An exploratory study of PQ Grass 27600 SU

A.4.1

Sponsor's protocol code number

PQGrass309

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	Allergy Therapeutics (UK) Ltd.
B.1.3.4	Country	United Kingdom
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	Allergy Therapeutics (UK) Ltd.
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bencard Allergie GmbH
B.5.2	Functional name of contact point	Clinical Research Management
B.5.3	Address:
B.5.3.1	Street Address	Leopoldstr. 175
B.5.3.2	Town/ city	Munich
B.5.3.3	Post code	80804
B.5.3.4	Country	Germany
B.5.6	E-mail	pqgrass309@allergytherapeutics.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.3.1	Product name	PQ Grass
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	MODIFIED ALLERGEN TYROSINE-ADSORBED
D.3.9.2	Current sponsor code	PQGrass
D.3.9.3	Other descriptive name	GRASS POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
D.3.9.4	EV Substance Code	SUB186988
D.3.10	Strength
D.3.10.1	Concentration unit	SU/ml Standardised Unit(s)/millilitre (Deprecated)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	900
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	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	PQ Grass
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	MODIFIED ALLERGEN TYROSINE-ADSORBED
D.3.9.2	Current sponsor code	PQGrass
D.3.9.3	Other descriptive name	GRASS POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
D.3.9.4	EV Substance Code	SUB186988
D.3.10	Strength
D.3.10.1	Concentration unit	SU/ml Standardised Unit(s)/millilitre (Deprecated)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2700
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: 3
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	PQ Grass
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	MODIFIED ALLERGEN TYROSINE-ADSORBED
D.3.9.2	Current sponsor code	PQGrass
D.3.9.3	Other descriptive name	GRASS POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
D.3.9.4	EV Substance Code	SUB186988
D.3.10	Strength
D.3.10.1	Concentration unit	SU/ml Standardised Unit(s)/millilitre (Deprecated)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6000
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	Suspension for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution 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

seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure

E.1.1.1

Medical condition in easily understood language

grass pollen allergy

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

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	10001728
E.1.2	Term	Allergic rhinoconjunctivitis
E.1.2	System Organ Class	100000004853

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 explore the efficacy of PQ Grass 27600 SU in grass pollen-induced seasonal allergic rhinitis and/or rhinoconjunctivitis in a field setting

E.2.2

Secondary objectives of the trial

To explore the treatment effect of PQ Grass on the CSMS and TCS over the GPS
To explore the treatment effect of PQ Grass on the dSS and dMS components of the CSMS over the GPS
To explore the treatment effect of PQ Grass on the dSS and dMS components of the TCS over the GPS
To explore the relationship between TSS during CPT and CSMS, TCS, dSS (for CSMS and TCS) and dMS (for CSMS and TCS) over the GPS compared to baseline
To evaluate well days and severe days during the GPS
To evaluate TSS during CPT at the same dose eliciting a positive response at baseline
To evaluate immunological parameters
To evaluate the quality of life
To evaluate the safety and tolerability of PQ Grass in subjects with grass pollen induced seasonal allergic rhinitis and/or rhinoconjunctivitis

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Title: Biomarker
Version and date: protocol version 4.0, 11Nov2020
Objective: Immunologic biomarkers will be evaluated in a sub-set of the subjects taking part in this study (EU subjects only). Leftover sample volume could be used for evaluation of additional allergy related biomarkers up to 10 years of the date of collection. The biomarker evaluation will include:
a. Serum immunoglobulins
b. Nasal immunoglobulins
c. Peripheral blood mononuclear cells (PBMCs)

E.3

Principal inclusion criteria

1. Capable of giving signed informed consent
2. Subject who has signed and dated the ICF.
3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol
6. Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass pollen.
For Detailed list see the protocol

E.4

Principal exclusion criteria

1. Pregnant or lactating subject.
2. Moderate to severe allergy symptoms during the screening and treatment periods, and/or GPS caused by perennial allergens or seasonal allergens (other than grass).
3. Subjects with a positive SPT at US sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure.
4. Moderate to severe symptoms during the 3 years prior to Visit 1 to another seasonal or perennial allergen not tested in the SPT that cannot be avoided during the study and the symptoms of which may interfere with administration of treatment and/or impact the data collected, as determined by the investigator.
5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
6. History of autoimmune disease including Hashimoto’s thyroiditis or other immunological disorder or other diseases that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment.
7. Presence of severe or uncontrolled or partly controlled Asthma.
8. History of any allergen SIT.
For Detailed List see the Protocol

E.5 End points

E.5.1

Primary end point(s)

The CSMS averaged over the peak grass pollen season (GPS)

E.5.1.1

Timepoint(s) of evaluation of this end point

daily during the GPS

E.5.2

Secondary end point(s)

CSMS averaged over the entire (or truncated) GPS
TCS averaged over the peak GPS
TCS averaged over the entire (or truncated) GPS
dSS component of the CSMS averaged over the peak GPS and entire (or truncated) GPS
dMS component of the CSMS averaged over the peak GPS and entire (or truncated) GPS
dSS component of the TCS averaged over the peak GPS and entire (or truncated) GPS
dMS component of the TCS averaged over the peak GPS and entire (or truncated) GPS
TSS during CPT, CSMS, TCS, dSS (for CSMS and TCS) and dMS (for CSMS and TCS) over the peak and entire (or truncated) GPS for subjects with a positive CPT at baseline
The probability of well days and severe days during the peak and entire (or truncated) GPS
Pre-GPS (Visit 12) TSS measured during CPT
Serum Ig responses (total IgE; grass-specific IgE and IgG4; specific IgE/total IgE and specific IgE/specific IgG4) at Visit 12 and Visit 15
Rhinoconjunctivitis quality of life questionnaire with standardised activities (RQLQ(S)) measured within the GPS
Frequency, severity and relationship of AEs to treatment
Frequency of AEs leading to premature discontinuation from treatment or study
Frequency of AESI
Changes in clinical laboratory values (chemistry, haematology,
urinalysis) between screening and Visit 15
Changes in vital signs (all subjects) and PEFR (only in subjects with past or current asthma) at all treatment visits

E.5.2.1

Timepoint(s) of evaluation of this end point

daily / during the GPS / during the course of the study as indicated in the protocol

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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)

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

Yes

E.8.2.3.1

Comparator description

different treatment schedule - extended posology

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

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

Germany

United States

E.8.7

Trial has a data monitoring committee

Yes

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 study (EoS) is defined as the date of the last 6 months telephone follow-up call of the last subject in the study.

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:

135

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

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

F.4.2.2

In the whole clinical trial

150

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)

At the end of the study participation, subjects will be treated according to local practices.

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

2020-08-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-09-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-10-28

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