Pilot study on efficacy and safety of bilastine in preventing angioedema attacks in patients with recurrent angioedema of unkown etiology (idiopatic angioedema, rIAE)

Pilot study on efficacy and safety of bilastine in preventing angioedema attacks in patients with recurrent angioedema of unkown etiology (idiopatic angioedema, rIAE) - Right

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003002-91-IT

Enrollment

Registered

2013-08-12

Start date

2013-11-04

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent idiopathic angioedema

Interventions

Trade Name: ROBILAS Product Name: ROBILAS Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Subjects must have given a written informed consent; 2.Male or female; 3.Age = 18 years; 4.Diagnosis of recurrent IAE (according to Kaplan-Greaves 2005 criteria - Annex ) 5.History of = 9 days of moderate to severe cutaneous or mucosal angioedema during the last 12 weeks; 6.C1-inhibitor functional levels = 60% of normal values; 7.Able to complete screening and assessments; 8.Women of childbearing potential must have a negative urine pregnancy test; 9.Willingness and ability to participate in the study; 10.No other experimental treatments; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1.Diagnosis of angioedema of any defined cause: allergic, hereditary/acquired C1-Inhibitor deficiency, ACE (Angiotensin Converting Enzyme) inhibitor or NSAID induced angioedema, drug and/or food/disease induced angioedema (according to Kaplan-Greaves 2005 criteria); 2.Participation in a clinical trial of another Investigational Product (IP) within the past month; 3.Chronic use within the last 3 month before recruitment of systemic or topical corticosteroids, any other systemic antihistamine, anti-leukotrienes, sodium cromoglycate or nedocromil, tricyclic antidepressants, ACE-inibhitors, ARB (Angiotensin Receptor Blockers), tranexamic acid, with the exception of the case in which some of them have been used for the angioedema attacks. 4.Use of antihistamines or corticosteroids within the week prior to study randomization. 5.Evidence of clinically relevant or chronic disease or condition that upon the judgment of the investigator contraindicates participation to the study (eg history of autoimmune disorders, Hodgkin’s disease, cardiovascular, neurological, hepatic, renal or malignant diseases); 6.Pregnancy and/or breast-feeding; 7.Mental condition rendering the subject, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study; 8.Unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason; 9.Known hypersensitivity to bilastine, its excipients, H1-antihistamines, benzimidazoles

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of the antihistamine bilastine, in comparison to placebo, in preventing angioedema attacks evaluated as reduction in the number of days with moderate to severe angioedema in patients with rIAE, angioedema in 12 weeks of treatment; Secondary Objective: 1.To assess the proportion of subjects with = 4 days with moderate to severe angioedema at the end of 12 weeks of treatment. 2.To assess the duration (days) of treatment for angioedema attacks. 3.To assess the safety and tolerability of bilastine. ;Primary end point(s): To assess the efficacy of the antihistamine bilastine, in comparison to placebo, in preventing angioedema attacks evaluated as reduction in the number of days with moderate to severe angioedema in patients with rIAE, angioedema in 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: Baseline assessment prior to randomization; final assessment at the end of treatment	—

Measure

Time frame

Main Objective: To assess the efficacy of the antihistamine bilastine, in comparison to placebo, in preventing angioedema attacks evaluated as reduction in the number of days with moderate to severe angioedema in patients with rIAE, angioedema in 12 weeks of treatment; Secondary Objective: 1.To assess the proportion of subjects with = 4 days with moderate to severe angioedema at the end of 12 weeks of treatment. 2.To assess the duration (days) of treatment for angioedema attacks. 3.To assess the safety and tolerability of bilastine. ;Primary end point(s): To assess the efficacy of the antihistamine bilastine, in comparison to placebo, in preventing angioedema attacks evaluated as reduction in the number of days with moderate to severe angioedema in patients with rIAE, angioedema in 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: Baseline assessment prior to randomization; final assessment at the end of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 1.To assess the proportion of subjects with = 4 days with moderate to severe angioedema at the end of 12 weeks of treatment. 2.To assess the duration (days) of treatment for angioedema attacks. 3.To assess the safety and tolerability of bilastine. ;Timepoint(s) of evaluation of this end point: Randomization visit until 30 days after the end of treatment	—

Countries

Italy

Contacts

Public ContactAlessandra Spinali

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

ASpinali@menarini.it003905556801

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026