Clinical Trials Register

Summary
EudraCT Number:	2021-003011-26
Sponsor's Protocol Code Number:	BILA-4021/PED
National Competent Authority:	Lithuania - SMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-09-13
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

Lithuania - SMCA

A.2

EudraCT number

2021-003011-26

A.3

Full title of the trial

A multicentre, open-label clinical trial to assess plasma levels and safety of bilastine in children from 2 to 5 years of age with seasonal and/or perennial allergic rhinoconjunctivitis or urticaria

A.3.1

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

A clinical trial investigating the plasma concentration and the safety of bilastine in children between 2 and 5 years old treated for allergic rhinoconjunctivitis or urticaria

A.4.1

Sponsor's protocol code number

BILA-4021/PED

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	FAES FARMA S.A.
B.1.3.4	Country	Spain
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	FAES FARMA S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FAES FARMA S.A.
B.5.2	Functional name of contact point	R&D and Innovation Department
B.5.3	Address:
B.5.3.1	Street Address	Av. Autonomía 10
B.5.3.2	Town/ city	Leioa (Bizkaia)
B.5.3.3	Post code	48940
B.5.3.4	Country	Spain
B.5.4	Telephone number	34663626137
B.5.6	E-mail	itziarmartin@faes.es

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.2.1.1.1	Trade name	Bilaxten
D.2.1.1.2	Name of the Marketing Authorisation holder	FAES FARMA, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Bilastine 10 mg orodispersible tablets
D.3.4	Pharmaceutical form	Orodispersible tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BILASTINE
D.3.9.1	CAS number	202189-78-4
D.3.9.3	Other descriptive name	BILASTINE
D.3.9.4	EV Substance Code	SUB37845
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Allergic rhinoconjunctivitis.
Urticaria.

E.1.1.1

Medical condition in easily understood language

Stuffy and runny nose with or without pink eye.
Skin rash with red raised, itchy bumps.

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10046735
E.1.2	Term	Urticaria
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue 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

To obtain bilastine plasma concentrations after the administration of multiple oral doses over a treatment period of 7 (+3) days in children between the ages of 2 and 5 years old with seasonal and/or perennial allergic rhinoconjunctivitis (SAR/PAR) or urticaria.

E.2.2

Secondary objectives of the trial

To evaluate the safety of bilastine after the administration of multiple oral doses over a treatment period of 7 (+3) or 14 (+6) days in children between the ages of 2 and 5 years with SAR/PAR or urticaria.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Boys and girls between the ages of 2 and 5 years, inclusive, at V1 screening.
2. Weight ≥ 10 kg.
3. Documented history of mild to moderate seasonal and/or perennial allergic rhinoconjunctivitis or urticaria before or during V1. Subjects must be symptomatic at screening as judged by the investigator, and therefore, susceptible to oral antihistamine treatment.
4. For subjects with allergic rhinoconjunctivitis: Documented positive skin prick test and/or any positive validated IgE test to at least one seasonal (e.g. grass, ragweed, and/or tree pollen etc.) and/or perennial allergen (e.g. cat dander, dog dander, dust mites and/or cockroach etc.) within lifetime before V1 or a positive skin prick test / test for specific IgE at V1. A positive skin prick test is defined as one with diameter of the wheal 3 mm greater than the diluent control. A positive IgE test is defined to have a Class 3 positivity of ≥ 3.5 – 17.5 kUA/L.
5. Subjects who have written consent from their legally accepted representatives (LARs) to participate in the clinical trial.

E.4

Principal exclusion criteria

1. Non-allergic rhinoconjunctivitis diagnosis.
2. Known allergy/hypersensitivity to bilastine or its inactive ingredients.
3. Intake of prohibited prior and concomitant medication.
4. Any clinical conditions or relevant history of acute or chronic conditions that in the opinion of the investigator would make the subject unsuitable for the clinical trial or interfere with the objectives of the clinical trial.
5. Subjects or LARs who are unable to comply with the clinical trial requirements (e.g. attendance to visits, prohibited medication intake etc.) or subjects who are unable to take the trial treatment.
6. Participation in another clinical trial within 30 days prior to screening or 5 half-lives of IMP (whichever is longer).
7. Subjects, whose LARs are employees of the investigator or clinical trial site, with direct involvement in the proposed clinical trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator.
8. Subjects, whose LARs are committed to an institution by virtue of an order issued either by the judicial or other authorities.

E.5 End points

E.5.1

Primary end point(s)

Value (ng/mL) for bilastine plasma concentrations.

E.5.1.1

Timepoint(s) of evaluation of this end point

Bilastine plasma concentrations after the administration of multiple oral doses over a treatment period of 7 (+3) days.

E.5.2

Secondary end point(s)

• Frequency of treatment emergent adverse events (TEAEs).
• Frequency of non-serious TEAEs.
• Frequency of related TEAEs.
• Frequency of TEAEs by severity.
• Frequency of serious TEAEs (related/unrelated).
• Frequency of TEAEs leading to discontinuation of investigational medicinal product (IMP).
• Incidence of TEAEs leading to death.
• Physical examination, clinically significant changes from baseline to V3 and V4.
• Vital signs (body temperature, heart rate), clinically significant changes from baseline to V3 and V4.

E.5.2.1

Timepoint(s) of evaluation of this end point

Safety of bilastine after the administration of multiple oral doses over a treatment period of 7 (+3) or 14 (+6) days.

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

E.6.6

Pharmacokinetic

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Children aged 2-5 years

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

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 termination of IMP intake, 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

2021-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-11-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-04-21

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