A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Biological: Ligelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02649218

2015-003636-13 (EudraCT Number)

CQGE031C2201E1

Details and patient eligibility

About

A safety 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

Full description

A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients

Enrollment: 226 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients eligible for inclusion in this study have to fulfill all of the following criteria:

  1. Written informed consent must be obtained before any assessment is performed.
  2. 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.
  3. 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).
  4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

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 criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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226 participants in 1 patient group

Ligelizumab

Experimental group

Description:

QGE031 240 mg s.c. q4w x 13 treatments

Treatment:

Biological: Ligelizumab