A Phase III study of efficacy and safety of ligelizumab in the treatment of Chronic Spontaneous Urticaria in adolescents and adults inadequately controlled with H1-antihistamines

Phase 1

• Conditions: Chronic Spontaneous Urticaria; MedDRA version: 20.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-000839-28-ES
• Lead Sponsor: ovartis Farmacéutica, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-13
• Study Completion: 2022-06-14
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1072

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study. The subject’s, parent’s or legal guardian’s signed written informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed.
? Male and female subjects = 12 years of age at the time of screening.
? CSU diagnosis for = 6 months.
? Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
? The presence of itch and hives for = 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
? UAS7 score (range 0-42) = 16 and HSS7 (range 0-21) = 8 during the 7 days prior to randomization (Visit 110, Day 1)
? Subjects must be on H1-antihistamine at only approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
? Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
? Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 950
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
? Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergicor contact-urticaria.
? Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
? Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
? Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
? Prior exposure to ligelizumab or omalizumab.
? Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.
? Other protocol-defined exclusion criteria may apply

Study & Design

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