Overview

A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
The study is a global 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 patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Treatments:
Histamine Antagonists
Histamine H1 Antagonists
Omalizumab
Criteria
Inclusion Criteria:

- Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU)
CIU/CSU refractory to H1 antihistamines at the time of randomization.

Exclusion Criteria:

- Treatment with an investigational agent within 30 days prior to screening.

- Weight < 20 kg (44 lbs).

- Clearly defined underlying etiology for chronic urticarias other than CIU.

- Evidence of parasitic infection.

- Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or
other skin disease associated with itch.

- Previous treatment with omalizumab within a year prior to screening.

- Routine doses of the following medications within 30 days prior to screening: Systemic
or cutaneous (topical) corticosteroids (prescription or over the counter),
hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.

- Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to
screening.

- Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.

- Any H2 antihistamine use within 7 days prior to screening.

- Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days
prior to screening.

- Any H1 antihistamines at greater than approved doses within 3 days prior to screening.

- Patients with current malignancy, history of malignancy, or currently under work-up
for suspected malignancy except non-melanoma skin cancer that has been treated or
excised and is considered resolved.

- Hypersensitivity to omalizumab or any component of the formulation.

- History of anaphylactic shock.

- Presence of clinically significant cardiovascular, neurological, psychiatric,
metabolic, or other pathological conditions that could interfere with the
interpretation of the study results and or compromise the safety of the patients.

- Evidence of current drug or alcohol abuse.

- Nursing women or women of childbearing potential, unless they meet the following
definition of post-menopausal: 12 months of natural amenorrhea or 6 months of
spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40
milli-international units per milliliter (mIU/mL) or 6 weeks post surgical bilateral
oophorectomy (with or without hysterectomy) or hysterectomy or are using one or more
of the following acceptable methods of contraception: surgical sterilization, hormonal
contraception, and double-barrier methods.