A long-term safety study for QGE031 as an add-on therapy for adults with CSU who have completed study CQGE031C2201

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 patients who completed study CQGE031C2201

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003636-13-ES

Enrollment

240

Registered

2016-02-03

Start date

2016-03-18

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Chronic Spontaneous Urticaria MedDRA version: 18.1 Level: LLT Classification code 10009159 Term: Chronic urticaria System Organ Class: 100000004858

Interventions

Product Code: QGE031 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ligelizumab Current Sponsor code: QGE031 Other des

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who complete study treatment epoch and at least visit 203 in the follow-up epoch in study QGE031C2201 - Present with active disease as defined by UAS7 ?12 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - New onset of chronic urticaria other than CSU during the follow-up epoch of study CQGE031C2201.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the long-term safety of QGE031 (240 mg s.c.) given every 4 weeks for 12 months in patients who completed study CQGE301C2201 by evaluation of: - Incidence and severity of all adverse events - Changes in vital signs, laboratory assessments, and ECGs ; Secondary Objective: To evaluate long-term treatment outcomes of QGE031 in adult patients with CSU by evaluation of: - Sustained remission defined as maintaining UAS7 ? 6 over 48 weeks post-treatment follow up epoch among the subjects achieving remission at the end of treatment epoch ; Primary end point(s): assess the long-term safety of QGE031 in adult CSU patients who completed the core study CQGE031C2201 using the following evaluations: - Incidence and severity of non-serious and serious adverse events including any events of special interest - Changes in vital signs, laboratory assessments, and ECGs ;Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the long-term safety of QGE031 (240 mg s.c.) given every 4 weeks for 12 months in patients who completed study CQGE301C2201 by evaluation of: - Incidence and severity of all adverse events - Changes in vital signs, laboratory assessments, and ECGs ; Secondary Objective: To evaluate long-term treatment outcomes of QGE031 in adult patients with CSU by evaluation of: - Sustained remission defined as maintaining UAS7 ? 6 over 48 weeks post-treatment follow up epoch among the subjects achieving remission at the end of treatment epoch ; Primary end point(s): assess the long-term safety of QGE031 in adult CSU patients who completed the core study CQGE031C2201 using the following evaluations: - Incidence and severity of non-serious and serious adverse events including any events of special interest - Changes in vital signs, laboratory assessments, and ECGs ;Timepoint(s) of evaluation of this end point: 52 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - Sustained remission defined as maintaining UAS7 ? 6 over 48 weeks post-treatment follow up epoch among the subjects achieving remission at the end of treatment epoch;Timepoint(s) of evaluation of this end point: 48 weeks	—

Countries

Australia, Canada, Germany, Greece, Japan, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactDepartamento Médico (ICRO)

Novartis Farmacéutica, S.A.

eecc.novartis@novartis.com+34900353036

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026