Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Urticaria

Treatments: Drug: Clemastine; Drug: Loratadine; Drug: Placebo to omalizumab; Drug: Omalizumab 75-375 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00481676

CIGE025ADE05

Details and patient eligibility

About

This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.

Enrollment: 49 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females from 18-70 years of age
• Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL
• Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening
• Diagnosis of moderate to severe chronic urticaria
• Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening
• Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer
• Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period
• UAS7 ≥ 10 at the time of randomization

Exclusion criteria

• Females of child-bearing potential or breast feeding
• Present or past medical conditions that could have interfered with the study results
• Randomized into any other omalizumab study or who had received omalizumab
• Received investigational drugs within 30 days of enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

Omalizumab 75-375 mg

Experimental group

Description:

Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.

Treatment:

Drug: Omalizumab 75-375 mg

Drug: Loratadine

Placebo to omalizumab

Placebo Comparator group

Description:

Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.

Treatment:

Drug: Clemastine

Drug: Loratadine

Drug: Placebo to omalizumab