Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Other: Placebo; Biological: QGE031; Biological: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02477332

2014-005559-16 (EudraCT Number)

CQGE031C2201

Details and patient eligibility

About

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

Enrollment: 382 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic spontaneous urticaria for at least 6 months
• Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Exclusion criteria

• Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
• Evidence of parasitic infection
• Any other skin disease with chronic itching
• Previous treatment with omalizumab or QGE031
• 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: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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382 participants in 6 patient groups, including a placebo group

QGE031 24 mg s.c. q4w

Experimental group

Description:

ligelizumab 24 mg injection subcutaneous every 4 weeks

Treatment:

Biological: QGE031

QGE031 72 mg s.c. q4w

Experimental group

Description:

ligelizumab 72 mg injection subcutaneous every 4 weeks

Treatment:

Biological: QGE031

QGE031 240 mg s.c. q4w

Experimental group

Description:

ligelizumab 240 mg injection subcutaneous every 4 weeks

Treatment:

Biological: QGE031

Omalizumab 300 mg s.c. q4w

Active Comparator group

Description:

omalizumab 300 mg injection subcutaneous every 4 weeks

Treatment:

Biological: Omalizumab

Placebo s.c. q4w

Placebo Comparator group

Description:

placebo injection subcutaneous every 4 weeks

Treatment:

Other: Placebo

QGE031 120 mg s.c. s.d.

Experimental group

Description:

ligelizumab 120 mg injection subcutaneous single dose

Treatment:

Biological: QGE031