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

Registry ID

EUCTR2015-003636-13

Source registry

EUCTR

Status

Completed

Phase

PHASE2

Sponsor

Novartis Pharma Services AG

Start date

2016-01-21

Completion date

2019-05-02

Last update

2026-08-16

Conditions

• Chronic Spontaneous Urticaria

Summary

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

Locations

• , , Greece
• , , Germany
• , , UK
• , , Spain

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