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

Conditions

• Chronic Idiopathic Urticaria

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
• Placebo — DRUG
  Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
• H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist — DRUG
  Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.
• Diphenhydramine — DRUG
  Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.

Study Details

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 chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).

Key Dates

Start date

Feb 28, 2011

Status verified

Sep 2013

Primary completion

Nov 30, 2012

Completion

Nov 30, 2012

Study Design

Enrollment

336 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
• Experimental: Omalizumab 300 mg
  Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.

Primary Outcome Measure

Percentage of Participants With Adverse Events [ Time Frame: Baseline to the end of study (up to 40 weeks) ]

Locations (40)