Conditions: Chronic Idiopathic Urticaria
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 336
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period. arm 2: Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.

Interventions: intervention 1: Omalizumab intervention 2: Placebo intervention 3: H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist intervention 4: Diphenhydramine
Intervention descriptions: intervention 1: Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial. intervention 2: Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug. intervention 3: 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. intervention 4: 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.

Protocol document: