Clinical Trials Register

Summary
EudraCT Number:	2012-000416-28
Sponsor's Protocol Code Number:	6043-PG-PSC-192
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-05-15
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

Czechia - SUKL

A.2

EudraCT number

2012-000416-28

A.3

Full title of the trial

A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum in Patients with Allergic Rhinitis and/or Rhinoconjunctivitis with or without Intermittent Asthma

Randomizovaná, multicentrická, dvojitě zaslepená studie s paralelními skupinami pro zhodnocení účinnosti a bezpečnosti čtyř koncentrací Depigoid® Phleum u pacientů s alergickou rýmou a/nebo rinokonjunktivitidou, s nebo bez intermitentního astmatu

A.3.1

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

Blinded, randomly distributed 4-group study for finding the most efficient dose of Depigoid® Phleum in patients with hay fever with/without asthma.

Zaslepená, randomizovaná do čtyřech oddělených skupin pro nalezení nejúčinnější dávky Depigoid® Phleum u pacientů se sennou rýmou s a/nebo bez astmatu.

A.4.1

Sponsor's protocol code number

6043-PG-PSC-192

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	LETI Pharma GmbH
B.1.3.4	Country	Germany
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	LETI Pharma GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LETI Pharma GmbH
B.5.2	Functional name of contact point	Medical Department
B.5.3	Address:
B.5.3.1	Street Address	Stockumer Straße 28
B.5.3.2	Town/ city	Witten
B.5.3.3	Post code	58453
B.5.3.4	Country	Germany
B.5.4	Telephone number	+492302202860
B.5.5	Fax number	+4923022028620
B.5.6	E-mail	info@leti.de

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	Depigoid® Phleum 100 DPP/ml
D.3.2	Product code	Depigoid® Phleum
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.3.9.2	Current sponsor code	Depigoid® Phleum
D.3.9.3	Other descriptive name	Chemically modified extract of grass pollens' allergens
D.3.9.4	EV Substance Code	SUB26420
D.3.10	Strength
D.3.10.1	Concentration unit	Other
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)	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	Depigoid® Phleum 1000 DPP/ml
D.3.2	Product code	Depigoid® Phleum
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.3.9.2	Current sponsor code	Depigoid® Phleum
D.3.9.3	Other descriptive name	Chemically modified extract of grass pollens' allergens
D.3.9.4	EV Substance Code	SUB26420
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
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	Depigoid® Phleum 5000 DPP/ml
D.3.2	Product code	Depigoid® Phleum
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.3.9.2	Current sponsor code	Depigoid® Phleum
D.3.9.3	Other descriptive name	Chemically modified drass pollens' allergens
D.3.9.4	EV Substance Code	SUB26420
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5000
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: 4
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	Depigoid® Phleum 10.000 DPP/ml
D.3.2	Product code	Depigoid® Phleum
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.3.9.2	Current sponsor code	Depigoid® Phleum
D.3.9.3	Other descriptive name	chemically modified extract of grass pollens' allergens
D.3.9.4	EV Substance Code	SUB26420
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10000
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Allergic Rhinitis and/or Rhinoconjunctivitis with or without Intermittent Asthma

E.1.1.1

Medical condition in easily understood language

Hay fever with or without asthma due to grass pollen.

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10001728
E.1.2	Term	Allergic rhinoconjunctivitis
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10001723
E.1.2	Term	Allergic rhinitis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10001705
E.1.2	Term	Allergic asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assessment of effective dose range and the optimum dose of Depigoid® Phleum administered subcutaneously in adult patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma.

E.2.2

Secondary objectives of the trial

Assessment the safety and tolerability of 4 different concentrations of Depigoid® Phleum administered subcutaneously during a 20-week treatment period.

Exploration of mechanism of action of the treatment with Depigoid® Phleum administered subcutaneously by measuring immunology laboratory parameters in adult patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma.

Assessment of the influence of baseline vitamin D levels on the efficacy of a 20-week treatment period with Depigoid® Phleum administered subcutaneously in adult patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must meet ALL the following inclusion criteria to be considered for admission to the study:

1. Has provided appropriately signed and dated informed consent.

2. Is a male or female aged ≥ 18 years and ≤ 70 years of age at Visit 1.

3. Has a perception of disease activity of at least 30 mm on a 100 mm VAS.

4. Has an FEV1 or a PEFR value > 80% of predicted normal value.

5. Has complained about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years, with or without intermittent asthma symptoms, caused by clinical sensitisation against grass pollen. The IgE-mediated sensitisation must be verified by the following: suggestive medical history AND specific IgE against grass pollen using an ImmunoCAP specific IgE radioallergosorbent test (CAP-RAST) ≥ 2 AND a positive SPT AND a positive CPT for grass pollen.

An SPT will be considered positive if the test results in a wheal diameter that is at least 3 mm or - if smaller - equal to the histamine reaction.
A CPT will be considered positive if a score of 5 is achieved after treatment with any one of the following concentrations: 100, 330, 1,000, 3,300 or 10,000 SQ-U/mL.
Patients with co-allergies are allowed to enter the study:
• being asymptomatic against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Ambrosia elatior [ragweed]),
• with specific IgE CAP-RAST co-allergen < grass, as specified below:
- Birch (or other trees): specific IgE CAP-RAST of < 2 with a difference to grass of ≥ 2 and a negative SPT test OR a negative CPT,
- House dust mites: specific IgE CAP RAST of < 2 with a difference to grass of ≥ 2 and a negative SPT,
- Cats and dogs:
- exposed to animal: specific IgE CAP-RAST animal < grass with a difference to grass of ≥ 2 and an SPT wheal diameter co-allergen < grass
- not exposed to animal: CAP-RAST animal < grass.
- other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Ambrosia elatior [ragweed]): specific IgE CAP-RAST of < 2 with a difference to grass of ≥ 2 and a negative SPT test OR a negative CPT.

All other co-allergens: difference in specific IgE CAP RAST co-allergen to grass of ≥ 2 and an SPT wheal diameter co-allergen < grass.

6. If a female is of non-childbearing potential, the patient must be postmenopausal for at least 1 year or surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

7. If a female is of childbearing potential, the patient must be non-lactating and non-pregnant (with a negative pregnancy test result at Visit 1) and must correctly use an effective method of contraception
during the study. An effective method of contraception is defined as one that results in a failure rate of less than 1% per year. The following are allowed methods of contraception when used continuously and properly: hormonal contraceptives administered by implant, injection, or orally; complete abstinence; partner’s vasectomy if the female has
not more than one partner. Barrier methods (e.g., preservatives) are only considered effective if used together with one of the above.

E.4

Principal exclusion criteria

Patients presenting any one of the following exclusion criteria must not be included in the study:

1. Acute, chronic or infectious conjunctivitis.

2. Has a history of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial allergens (e.g., house dust mites).

Patients are not allowed to enter into the study:
• with typical symptoms against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Ambrosia elatior [ragweed]),
• with CAP-RAST co-allergen ≥ grass.

3. Has persistent asthma, according to Global Initiative for Asthma (GINA) Guidelines32.

4. Has acute or chronic inflammatory or infectious airways disease.

5. Has chronic structural disease of the lung (e.g., emphysema or bronchiectasis).

6. Has an autoimmune and/or immune deficiency.

7. Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).

8. Has a severe uncontrolled disease that could increase the risk to the patients while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.

9. Has had active malignant disease during the previous 5 years.

10. Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient.

11. Has abused alcohol, drugs or medications within the past year.

12. Has a severe psychiatric, psychological or neurological disorder.

13. Has used immunotherapy against grass pollen within the last 5 years.

14. Has used systemic and/or topical treatment with β-blockers within 1 week prior to Visit 2.

15. Is using any medication that may interfere with the immune system or has been using any medication which might still have an influence on the immune system at Visit 2.

16. Has used tranquiliser or psychoactive drugs within 1 week prior to Visit 1.

17. Has used systemic corticosteroids within 3 months prior to Visit 1.

18. Has been immunised with vaccines within 7 days prior to Visit 2.

19. Is expected to be non-compliant and/or not cooperative.

20. Has participated in another clinical study within 30 days prior to Visit 2.

21. Has already participated in this study.

22. Is an employee at the investigational centre or first degree relative or partner of the investigator.

23. Plans to donate germ cells, blood, organs or bone marrow during the course of the study.

24. Is not contractually capable.

25. Has a positive pregnancy test at
Visit 1.

26. Is jurisdictionally or governmentally institutionalised.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients who need an increased amount of allergen to elicit a positive CPT performed after 20 weeks of treatment in comparison to baseline (i.e.; comparing the results from follow-up Visit 8 with those at baseline (Visit 1).

E.5.1.1

Timepoint(s) of evaluation of this end point

CPT baseline to visit 7

E.5.2

Secondary end point(s)

Secondary safety endpoints are:
• Patients (%) suffering from systemic reactions (Grades 1 to 4) during the treatment period,
• Patients (%) suffering from local reactions during the treatment period,
• Patients (%) withdrawn from the study due to systemic reactions (Grades 1 to 4) during the build-up phase,
• Patients (%) withdrawn from the study due to local reactions during the build-up phase,
• Patients (%) suffering from different severity levels of systemic reactions during the treatment period,
• Patients (%) suffering from different severity levels of local reactions during the treatment period,
• Patients (%) withdrawn from the study due to systemic reactions during the treatment period,
• Patients (%) withdrawn from the study due to local reactions during the treatment period,
• Change from baseline to the end of the treatment period in the clinical chemistry and haematological parameters,
• Change of lung function parameters before and after the administration of the IMP,
• Physician’s overall tolerability assessment,
• Patients’ overall tolerability assessment
• Immunology laboratory parameters: total and specific IgE, specific IgG1 and IgG4 and FAB assay,
• Baseline vitamin D levels versus efficacy outcome.

E.5.2.1

Timepoint(s) of evaluation of this end point

during treatment period

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

Yes

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

4 doses of Depigoid® Phleum

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.8.5

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

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

Last visit of the last subject.

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

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:

234

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

320

F.4.2.2

In the whole clinical trial

320

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 completing the double-blind study and in accordance with local laws and provisions, patients will be given the option to receive treatment with the marketed dose of Depigoid® Phleum as a patient care measure. This is to allow study participants to benefit from completing a full course of treatment for 3 consecutive years.

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

2012-08-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-08-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-04-25

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IMP with orphan designation in the indication
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Clinical trials