Study to evaluate the effectiveness, safety, and quality of life of Bilaxten, an allergy medication, in children

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

30 Mar 2026 → ongoing

Decision date (initial)

2026-01-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the efficacy of bilastine 10 mg ODT in children from ≥ 6 to < 12 years old with allergic rhinoconjunctivitis (AR), after 14 days of daily treatment, through the variation in AR symptoms, usinig a combined five symptoms score (mean change vs baseline in the T5CSS: sneezing, rhinorrhoea, nasal pruritus, tearing and ocular pruritus). Reflective AR symptoms will be collected daily, referring to the preceeding 12-24 hours, and these scores will be used fo the efficacy assessment.

Secondary objectives 10

1. Assessment of the variation of QoL in children with AR, as measured by the mean change from baseline in PRQLQ, after 14 days (with bilastine 10 mg ODT once daily).
2. Assessment of evolution of AR symptoms in children using variations in the T5CSS: a. as the daily change in the T5CSS after 7 days of treatment. b. as the daily change in the T5CSS after 14 days of treatment. c. as mean change from baseline in the T5CSS after 7 days of treatment.
3. Assessment of the variation of nasal AR symptoms [runny nose, nasal itching, nasal congestion and sneezing], in children with AR, after 7 and 14 days of treatment compared to baseline, using the TNSS
4. Assessment of the variation of non-nasal AR symptoms [ocular itching, tearing, ocular redness and itchy ears/palate], in children with AR, after 7 and 14 days of treatment compared to baseline, using the TNNSS.
5. Assessment of the variation of overall AR symptoms [sum of symptoms included in the TNSS and TNNSS], in children with AR, after 7 and 14 days of treatment compared to baseline, using the TSS
6. To determine whether there is a correlation between AR symptoms evolution (global and specific) and participants’ QoL after 14 days of treatment
7. Evaluation of the variation in the disease evaluation, after 14 days of treatment vs. baseline, as assessed by participants, parents and investigators, using the Global Disease Evaluation
8. Assessment of satisfaction with AR treatment from the perspective of participants and parents after 14 days of treatment with bilastine 10 mg ODT (once daily), using a satisfaction questionnarie
9. Assessment of treatment adherence with bilastine 10 mg ODT (once daily) during a 14-day treatment period
10. Assessment of the safety and tolerability of bilastine 10 mg ODT (once daily) during a 14-day treatment period

Conditions and MedDRA coding

Allergic rhinoconjunctivitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Participants of either sex (male or female) aged ≥ 6 and < 12 years with a body weight of at least 15 kg at the time of enrolment
2. Participants must have a documented clinical history (at least 1 year) of AR and must present mild-moderate clinical symptoms at the time of inclusion in the study
3. Participants with AR must have a positive skin reaction/RAST test documented in their clinical history within a year prior to the date of their inclusion in the study: a positive prick test (papule diameter of at least 3 mm) or specific IgE > 0.70 KUA/L, at least against one allergen.
4. Participants must have a clinical history of positive response to oral antihistamine treatment
5. Participants must have a T5CSS score ≥ 8 points (out of 15) instantaneous symptoms at the screening visit
6. Participants must have at least one analytical determination (haemogram, biochemistry) prior to entering in the study without clinically relevant abnormalities. Should there have been any past anomalies, it should be verified and documented with the corresponding analytical determination that they have been normalized and presents values within the normal range before inclusion in the study.
7. Participants should have a 12-lead ECG without clinically relevant abnormalities.
8. Written consent must be obtained from parents/LAR of the children for them to be included in the study. A signed assent form might be obtained from the participants, if required

Exclusion criteria 15

1. Rhinitis of non-allergic origin.
2. Administration of drugs with sedative properties
3. Known allergy and/or hypersensitivity to H1 antihistamines (specifically to the study medications -bilastine - or to their inactive ingredients) or to benzimidazoles
4. Participants who are taking or have taken any of the following medications prior to inclusion in the study and who have not complied with the specific washout period indicated below: a. Oral and nasal corticosteroids (within the 30 days before inclusion) b. Topical ocular or nasal antihistamines (within the 7 days before inclusion) c. Systemic antihistamines: i. loratadine and desloratadine: 10 days before inclusion ii. dexchlorpheniramine: 8 days before inclusion iii. ebastine and hydroxyzine: 6 days before inclusion iv. bilastine, fexofenadine, promethazine, cyproheptadine, oxatomide and clemastine: 5 days before inclusion v. cetirizine and levocetirizine: 3 days before inclusion vi. rupatadine: 2 days before inclusion d. Decongestants, anticholinergics (nasal spray or drops) (within the 3 days before inclusion) e. Anti-leukotrienes (within the 7 days before inclusion) f. Ketotifen (within the 2 weeks before inclusion) g. Delayed-acting corticosteroids (within the 3 months before inclusion) h. Macrolide antibiotics and imidazole fungicides (systemic) (within the 7 days before inclusion) i. Investigational medication or antibodies (within the 30 days before inclusion)
5. Participants with asthma treated with treatments other than β2 inhaled agonists
6. 6. Participants under treatment with drugs that are contraindicated or interact with the study drugs according to its SmPC, such as P-glycoprotein inhibitors (ketoconazole, erythromycin, cyclosporine, diltiazem), anticholinergics, drugs that prolong the QT interval and/or induce Torsade de Pointes, such as class IA antiarrhythmics (quinidine, etc. ) and class III (amiodarone, etc.), antipsychotics (haloperidol), antidepressants (citalopram, etc.), antimalarials (mefloquine, etc.), antibiotics (such as moxifloxacin) and antifungals (such as pentamidine). The association with some gastrointestinal drugs (such as prucalopride), cancer drugs (e.g. toremifene) or methadone should also be avoided.
7. Participants under treatment with Allergen-Specific Immunotherapy in the two years prior to inclusion in the study.
8. Participants under treatment with stimulant drugs and/or Central Nervous System depressants.
9. Girls with menarche.
10. Current or planned consumption of grapefruit, apple, orange, or other fruit juices known to affect drug absorption during the treatment period.
11. Any relevant clinical condition (or history) of renal, hepatic, gastrointestinal, cardiovascular, respiratory, hematologic, endocrine, or neurologic disease that would preclude the child from being suitable for participate in the study or that may interfere with the objectives of the study, in the opinion of the investigator.
12. Clinically relevant abnormalities in laboratory parameters (including ECG abnormalities) indicative of disease, in the opinion of the investigator.
13. Children or parents/LAR of the children unable to comply with the requirements of the study (attendance at visits), or children unable to adequately take the study treatment
14. Participation in another clinical trial within 30 days prior to ingestion of the first dose of study medication.
15. Any other characteristic of the participant or his/her environment, which in the investigator's judgment makes him/her unsuitable to participate in the study (e.g., detection or suspicion of drug or other substance abuse; if participation in the study may harm the child's health, etc.).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall AR symptoms will be evaluated through the mean change of the T5CSS score measured at baseline (V1) and after 14 days (V3) of treatment by a participant’s e-diary

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Faes Farma S.A.

Sponsor organisation

Faes Farma S.A.

Address

Autonomia Etorbidea 10

City

Leioa

Postcode

48940

Country

Spain

Scientific contact point

Organisation

Faes Farma S.A.

Contact name

Cristina Campo

Public contact point

Organisation

Faes Farma S.A.

Contact name

Evidenze Health España

Third parties 1

A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Sponsor organisation

A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Address

Via Dei Sette Santi 3

City

Florence

Postcode

50131

Country

Italy

Sponsor responsibilities

Article 77 compliance

Faes Farma S.A.

Contact point sponsor

Faes Farma S.A.

Article 77 implementation

Faes Farma S.A.

Locations

3 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications