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
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab; Placebo; H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist; Diphenhydramine
Intervention description: Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.; Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study 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.; 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.
Intervention MeSH terms: Omalizumab; Diphenhydramine; Promethazine; Leukotriene Antagonists; Histamine H1 Antagonists; Histamine Antagonists
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 336.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic idiopathic urticaria (CIU) refractory to H1 antihistamines, H2
             blockers, and/or leukotriene receptor antagonists (LTRA) at the time of randomization.

               -  The presence of itch and hives for > 6 consecutive weeks at any time prior to
                  enrollment despite current use of H1 antihistamine (up to 4 times the approved
                  dosage), H2 blocker, and/or LTRA treatment during this time.

               -  Urticaria activity score over 7 days (UAS7) score (range 0-42) ≥ 16 and itch
                  component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Week 0).

               -  In-clinic UAS ≥ 4 on at least one of the screening visit days (Day -14, Day -7,
                  or Day 1).

          -  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:

          -  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.

          -  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.

          -  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.