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A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01264939
First received: December 20, 2010
Last updated: December 13, 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 safety and efficacy 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 CIU who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to four times above the approved dose level), H2 blockers, and/or LTRA.


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, Placebo-Controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • ATA evaluation at the end of the follow-up period [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
  • Change in vital signs [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
  • Clinical laboratory evaluations [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events and serious adverse events [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in weekly itch score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: February 2011
Estimated Study Completion Date: April 2013
Primary Completion Date: November 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:

Inclusion Criteria

  • Diagnosis of CIU refractory to H1 antihistamines, H2 blockers, and/or LTRAs at the time of randomization
  • For women of childbearing potential, agreement to use an acceptable form of contraception and to continue its use for the duration of the study

Exclusion Criteria:

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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264939

  Show 72 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Edward R. Conner, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01264939     History of Changes
Other Study ID Numbers: Q4883g, GA00889
Study First Received: December 20, 2010
Last Updated: December 13, 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
Histamine H2 Antagonists
Leukotriene Antagonists
Omalizumab
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 19, 2013