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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01292473
First received: February 7, 2011
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Idiopathic Urticaria
 Drug: omalizumab
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Change from baseline in weekly hives score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Time to weekly itch score minimally important difference (MID) response [ Time Frame: By Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of adverse events and serious adverse events [ Time Frame: Up to week 28 ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: omalizumab
Repeating subcutaneous injection
Placebo Comparator: B Drug: placebo
Repeating subcutaneous injection

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of 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 less than 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
  • 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 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 FSH levels >40 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292473

  Show 61 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01292473     History of Changes
Other Study ID Numbers: Q4882g, GA00888
Study First Received: February 7, 2011
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Omalizumab
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013