Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Idiopathic Urticaria

Treatments: Drug: IGE025; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01599637

CIGE025E2201

2011-004216-31 (EudraCT Number)

Details and patient eligibility

About

The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamines at Baseline

Exclusion criteria

• Clearly defined underlying etiology for chronic urticarias other than CIU (main manifestation being physical urticaria). This includes the following urticarias: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact, as well as the following diseases as these diseases may have symptoms of urticaria or angioedema: Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer.
• Previous treatment with omalizumab.
• A history or presence of atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

IGE025

Experimental group

Description:

Patients will receive omalizumab administered subcutaneously every 4 weeks at the study center.

Treatment:

Drug: IGE025

Placebo to IGE025

Placebo Comparator group

Description:

Placebo administered subcutaneously every 4 weeks at the study center.

Treatment:

Drug: placebo