A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in CSU Patients

An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria (CSU) Patients Who Completed Study CQGE031C2201

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223242

Enrollment

Registered

2016-06-14

Start date

2016-06-04

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: *Patients eligible for inclusion in this study have to fulfill all of the following criteria: a. Written informed consent must be obtained before any assessment is performed. b. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch,>=16 weeks after last injection) and present with active disease as defined by UAS7 >=12. c. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met). d. 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: *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 *Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine *History of anaphylaxis *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 may apply

Design outcomes

Primary

Measure	Time frame
safety Number of participants with treatment-emergent adverse events (AEs) [ Time Frame: 2 years ] The primary objective of this study is to assess the long-term safety of QGE031 in adult CSU patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with AEs of non-serious and serious adverse events including any events of special interest.	—

Secondary

Measure	Time frame
efficacy Number of participants with sustained remission [ Time Frame: 2 years ] The secondary objective of this study is to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations: Sustained remission defined as maintaining UAS7 <= 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.	—

Measure

Time frame

efficacy Number of participants with sustained remission [ Time Frame: 2 years ] The secondary objective of this study is to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations: Sustained remission defined as maintaining UAS7 <= 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.

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Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

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