Study of efficacy and safety of ligelizumab in chronic spontaneous urticaria patients who completed a previous study with ligelizumab

A multi-center, double-blinded and open-label extension study to evaluate the efficacy and safety of ligelizumab as retreatment, self-administered therapy and monotherapy in Chronic Spontaneous Urticaria patients who completed studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225155

Enrollment

100

Registered

2020-04-07

Start date

2020-04-08

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic Spontaneous Urticaria

Interventions

investigational material(s) Generic name etc : INN of investigational material : Ligelizumab Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Written informed consent *Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301 *Male and female, adult and adolescent subjects >=12 years of age *Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule

Exclusion criteria

Exclusion criteria: *Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment *Use of omalizumab within 16 weeks of Screening *History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes *New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202. *Diseases with possible symptoms of urticaria or angioedema *Subjects with evidence of helminthic parasitic infection *Documented history of anaphylaxis *Pregnant or nursing (lactating) women

Design outcomes

Primary

Measure	Time frame
efficacy * The proportion of subjects with well-controlled disease (UAS7 <= 6) at Week 12	—

Secondary

Measure	Time frame
safety efficacy other * The proportion of subjects with completely controlled disease (UAS7 = 0) at Week 12 * Absolute change from extension study baseline in the UAS7 and its components (ISS7 and HSS7) at Week 12 * Cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12 * Percentage of subjects achieving DLQI = 0-1 at Week 12 * The proportion of subjects with well-controlled disease (UAS7 <= 6), 12 weeks after starting self-administration * To assess the safety and tolerability of ligelizumab in all subjects. Occurrence of treatment emergent adverse events during the study * To assess the safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer. Occurrence of treatment emergent adverse events	—

Measure

Time frame

safety efficacy other * The proportion of subjects with completely controlled disease (UAS7 = 0) at Week 12 * Absolute change from extension study baseline in the UAS7 and its components (ISS7 and HSS7) at Week 12 * Cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12 * Percentage of subjects achieving DLQI = 0-1 at Week 12 * The proportion of subjects with well-controlled disease (UAS7 <= 6), 12 weeks after starting self-administration * To assess the safety and tolerability of ligelizumab in all subjects. Occurrence of treatment emergent adverse events during the study * To assess the safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer. Occurrence of treatment emergent adverse events

—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactRyohei Iwasaki

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026