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

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

JPRN

Registry ID

JPRN-jRCT2080224087

Enrollment

Registered

2018-10-10

Start date

2018-10-20

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 : QGE031 INN of investigational material : Ligelizumab Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Diagnosis of chronic spontaneous urticaria for at least 6 months *Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Exclusion criteria

Exclusion criteria: *History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes *Clearly defined cause of chronic urticaria other than chronic spontaneous urticaria *Evidence of parasitic infection *Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results *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 inclusion/exclusion may apply

Design outcomes

Primary

Measure	Time frame
efficacy Absolute change from baseline in UAS7 at Week 12 [ Time Frame: Week 12 ] The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42. Complete hives response is defined as HSS7 (average daily HSS over the preceding 7 days) = 0. Complete itch response is defined as ISS7 (average daily ISS over the preceding 7 days) = 0. Complete UAS7 response is defined as UAS7=0.	—

Measure

Time frame

efficacy Absolute change from baseline in UAS7 at Week 12 [ Time Frame: Week 12 ] The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42. Complete hives response is defined as HSS7 (average daily HSS over the preceding 7 days) = 0. Complete itch response is defined as ISS7 (average daily ISS over the preceding 7 days) = 0. Complete UAS7 response is defined as UAS7=0.

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Secondary

Measure	Time frame
efficacy Complete absence of hives and itch at Week 12 [ Time Frame: Week 12 ] Assessed as percentage of subjects achieving UAS7 = 0 efficacy Improvement of severity of itch [ Time Frame: Week 12] Assessed as absolute change from baseline in ISS7 score at Week 12 efficacy No impact on subject's quality of life at Week 12 [ Time Frame: Week 12 ] Assessed as percentage of subjects achieving DLQI = 0-1 efficacy Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 [ Time Frame: Weekly to Week 12 ] To assess the cumulative period of time that treated subjects are angioedema occurrence-free safety Occurrence of treatment emergent adverse events and serious adverse events during the study [ Time Frame: 52 weeks ] Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started	—

Measure

Time frame

efficacy Complete absence of hives and itch at Week 12 [ Time Frame: Week 12 ] Assessed as percentage of subjects achieving UAS7 = 0 efficacy Improvement of severity of itch [ Time Frame: Week 12] Assessed as absolute change from baseline in ISS7 score at Week 12 efficacy No impact on subject's quality of life at Week 12 [ Time Frame: Week 12 ] Assessed as percentage of subjects achieving DLQI = 0-1 efficacy Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 [ Time Frame: Weekly to Week 12 ] To assess the cumulative period of time that treated subjects are angioedema occurrence-free safety Occurrence of treatment emergent adverse events and serious adverse events during the study [ Time Frame: 52 weeks ] Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started

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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