Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Spontaneous Uriticaria

Treatments: Other: Placebo; Biological: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02329223

CIGE025E2306

Details and patient eligibility

About

This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.

Enrollment: 218 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
• Chronic spontaneous urticaria diagnosis for 6 months

Key Exclusion Criteria:

• Weight less than 20 kg
• 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
• Previous treatment with omalizumab
• Contraindications to diphenhydramine
• History of anaphylactic shock
• History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
• History of hypersensitivity to omalizumab or to drugs of similar chemical classes
• Pregnant or nursing (lactating) women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 3 patient groups, including a placebo group

Omalizumab 300 mg

Experimental group

Description:

Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.

Treatment:

Biological: Omalizumab

Omalizumab 150 mg

Experimental group

Description:

Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.

Treatment:

Biological: Omalizumab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.

Treatment:

Other: Placebo