Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab 75-375 mg; Placebo to omalizumab; Loratadine; Clemastine
Intervention description: Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection.; Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection.; All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.; All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
Intervention MeSH terms: Omalizumab; Loratadine; Clemastine; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic urticaria, omalizumab, thyroperoxidase, IgE

Summary:

      This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to
      severe chronic urticaria who exhibit IgE against thyroperoxidase.
    

Eligibility criteria:

        Inclusion criteria:

          -  Males or females from 18-70 years of age

          -  Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700
             IU/mL

          -  Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to
             randomization or time of pre-screening

          -  Diagnosis of moderate to severe chronic urticaria

          -  Subject's current episode of chronic urticaria according to the European Academy of
             Allergology and Clinical Immunology/Global Allergy and Asthma European
             Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of
             screening

          -  Current episode of chronic urticaria has not responded to the approved marketed dose
             of antihistamine for 2 weeks or longer

          -  Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the
             screening period

          -  UAS7 ≥ 10 at the time of randomization

        Exclusion criteria:

          -  Females of child-bearing potential or breast feeding

          -  Present or past medical conditions that could have interfered with the study results

          -  Randomized into any other omalizumab study or who had received omalizumab

          -  Received investigational drugs within 30 days of enrollment