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

Phase 1

• Conditions: Allergic rhinoconjunctivitis. Urticaria.; MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; MedDRA version: 20.0Level: PTClassification code 10046735Term: UrticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-003011-26-PL
• Lead Sponsor: FAES FARMA S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-04
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 39

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 39
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: 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.;Primary end point(s): Value (ng/mL) for bilastine plasma concentrations.;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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Frequency of treatment emergent adverse events (TEAEs).<br>• Frequency of non-serious TEAEs.<br>• Frequency of related TEAEs.<br>• Frequency of TEAEs by severity.<br>• Frequency of serious TEAEs (related/unrelated).<br>• Frequency of TEAEs leading to discontinuation of investigational medicinal product (IMP).<br>• Incidence of TEAEs leading to death.<br>• Physical examination, clinically significant changes from baseline to V3 and V4.<br>• Vital signs (body temperature, heart rate), clinically significant changes from baseline to V3 and V4.;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.