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

Phase 1

• Conditions: Chronic Spontaneous Urticaria; MedDRA version: 18.1 Level: LLT Classification code 10009159 Term: Chronic urticaria System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-003636-13-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 240

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified