The purpose of the study is to evaluate the efficacy and safety of ligelizumab in treating adult and adolescent subjects with chronic spontaneous urticaria

A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016719

Enrollment

1050

Registered

2018-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

None listed

Interventions

Intervention1: Ligelizumab 72mg and 120mg: Subcutaneous injection 52 weeks treatment followed by 12 weeks of follow up Control Intervention1: Omalizumab 300mg: Subcutaneous injection 52 weeks treatm

Eligibility

Inclusion criteria

Inclusion criteria: Signed informed consent must be obtained prior to participation in the study Male and female subjects = 12 years of age at the time of screening CSU diagnosis for=6 months • 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.

Exclusion criteria

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-, cholinergic- or 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

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in UAS7 at week 12Timepoint: Absolute change from baseline in UAS7 at week 12	—

Secondary

Measure	Time frame
•Complete absence of hives and itch •Improvement of severity of itch •No impact on subjects quality of life at Week Timepoint: week 12	—

Countries

Argentina, Austria, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark, France, Germany, Greece, Guatemala, Hungary, India, Malaysia, Morocco, Oman, Peru, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United States of America

Contacts

Public ContactMurugananthan K

Novartis Pharma AG

murugananthan.k@novartis.com9122250243544

Outcome results