Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222941

Enrollment

Registered

2015-08-19

Start date

2015-08-19

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 : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational materia

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: *Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria *Evidence of parasitic infection *Any other skin diseases than chronic spontaneous urticaria with chronic itching *Previous treatment with omalizumab or QGE031 *Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine *History of anaphylactic shock *History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study *History of hypersensitivity to any of the study drugs or its components of similar chemical classes *Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply Other protocol defined inclusion/exclusion may apply

Design outcomes

Primary

Measure	Time frame
Complete hives response (HSS7=0) [Time Frame: Week 12] Complete hives response is defined as Hives Severity Score (HSS7) of 0	—

Secondary

Measure	Time frame
Complete hives response (HSS7=0) compared with omalizumab [Time Frame: Week 12] Complete hives response is defined as Hives Severity Score (HSS7=0) Complete hives response (HSS7=0) of individual QGE031 doses compared with omalizumab [Time Frame: Week 20] Complete hives response is defined as Hives Severity Score (HSS7) of 0	—

Outcome results

None listed

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