A clinical trial to compare three oral treatments and a placebo in preventing skin reactions caused by histamine in healthy volunteers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

9 May 2025 → 11 Jul 2025

Decision date (initial)

2025-04-10

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: Therapy

The primary objective of this study is to determine the onset of action of the peripheral antihistaminic activity of bilastine 20 mg orodispersible tablet, ebastine 10 mg oral lyophilized, and desloratadine 5 mg orodispersible tablet versus placebo orodispersible tablet

Secondary objectives 5

1. To evaluate the peripheral antihistaminic activity at each time point of the different study drugs versus that of placebo and versus their corresponding baseline values measured as percentage of inhibition of wheal and flare areas
2. To determine the maximum effect, maximum effect time and duration of effect of the treatments.
3. To evaluate the suppression of subjective sensation of itching after histamine inoculation.
4. To assess the safety and tolerability of the treatments.
5. To characterize the pharmacokinetic profile of bilastine 20 mg orodispersible tablets.

Conditions and MedDRA coding

Allergy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Free acceptance to participate in the study by obtaining signed informed consent form, approved by the hospital’s IEC.
2. Subjects of either sex (male or female) aged ≥ 18 and ≤ 50 years at the time of the enrolment.
3. Subjects not affected by any organic or psychic conditions.
4. No evidence of clinically significant abnormalities in medical records and physical examination, at screening.
5. No clinically significant abnormalities in haematology, biochemistry, or serology (hepatitis B surface antigen - HBsAg, hepatitis C antibodies – HCV Ab, or human immunodeficiency virus antibodies - HIV) assessments, at screening.
6. Vital signs (blood pressure, body temperature and heart rate) and electrocardiogram (ECG) record within normal range, at screening.
7. Body mass index within the range (BMI ≥ 18.5 and ≤ 30.0 kg/m2) expressed as weight (kg) / height (m2).
8. Women of childbearing potential must be willing to use a medically acceptable barrier method of contraception throughout the study and one week after the last IMP intake. Hormonal contraceptives and intrauterine hormone-releasing system (IUS) are not permitted.
9. Induced wheal area values within the reference range of the Research Institute [0.5521 cm2 – 2.5941 cm2], in the histamine skin reaction test performed during the selection.
10. Be willing to avoid excessive sun exposure or any procedure that could modify the colour of the skin.

Exclusion criteria 17

1. Background of allergy, idiosyncrasy or hypersensitivity to the IMP or any related products (including excipients of the formulations).
2. Heavy consumer of stimulating drinks (> 5 cups of coffee, tea, chocolate, or cola drinks per day).
3. History of alcohol dependence or drug abuse in the last 5 years, or daily alcohol consumption > 40 g/day for men or > 24 g/day for women.
4. Intake of any medication within 14 days prior to taking the IMP (except for use of paracetamol in short-term symptomatic treatments, according to the investigator’s criteria, and specified contraceptives), or intake of over-the-counter products (including natural food supplements, vitamins and medicinal plant products) within 7 days prior to taking the IMP.
5. Positive HBsAg, HCV Ab or HIV results.
6. Positive results for abuse drugs in urine test or ethanol in breath test.
7. History or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
8. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
9. Positive dermographism.
10. Females with positive results from the pregnancy test, breast-feeding or planning a pregnancy.
11. Smoking within 6 months prior to the study treatment phase. Smokers must refrain from any tobacco usage, including smokeless tobacco, nicotine patches, electronic cigarettes, etc. at least for 6 months prior to study treatment phase).
12. Have participated in another clinical trial during the 3 months prior to study start (screening visit) in which an investigational drug, medical device or a commercially available drug was tested.
13. Have donated blood within the 4 weeks period before the screening visit.
14. Having undergone major surgery during the previous 6 months before screening visit, or have an intervention programmed during the study.
15. Mentally or legally incapacitated at screening.
16. Unwillingness or inability to follow the procedures outlined in the protocol.
17. Any condition that, in the opinion of the investigator, may jeopardise the subject’s well-being or the trial conduct according to the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Onset of action: defined as the first time point (h) in which active treatments show a statistically significant difference in the inhibition of wheal and flare surface areas in comparison to that induced by placebo

Secondary endpoints 9

1. Percentage of reduction vs placebo: % of reduction of wheal and flare surface areas obtained in each time point after studies drugs administration versus placebo.
2. Percentage of reduction vs baseline: % of reduction of wheal and flare surface areas obtained in each time point after studies drugs administration, in comparison to their corresponding baseline value expressed in cm2
3. Maximum effect: maximum percentage of reduction of wheal and flare surface areas
4. Maximum effect time: time point (h) in which the maximum percentage of reduction of wheal and flare surface areas is reached
5. Duration of effect: last time point (h) where wheal and surface areas show statistically significant differences, compared to placebo and versus baseline
6. Subjective itching assessment: Mean change versus baseline on subjective itching sensation (VAS).
7. Tolerability: Changes in the tolerability parameters (clinical laboratory tests, vital signs recording, ECG parameters) evaluated in terms of clinical relevance.
8. Safety: Incidence of adverse events.
9. Pharmacokinetic parameters: Drug plasma concentration and pharmacokinetic parameters (AUC0t, AUC0∞, Cmax, tmax, t1/2, Kel, Cl, Vd) calculated from those plasma levels.

Investigational products

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

Test 3

Placebo 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

Rosa Mª Antonijoan

Public contact point

Organisation

Faes Farma S.A.

Contact name

Evidenze Health España

Third parties 2

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

1 EU/EEA country · 1 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 7 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