OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: omalizumab; omalizumab
Intervention description: 150mg omalizumab via sub-cutaneous injection once every 4 weeks; 300mg omalizumab via sub-cutaneous injection once every 4 weeks
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic spontaneous urticaria, CSU, chronic idiopathic urticaria, CIU, hives, angioedema, itch

Summary:

      This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or
      300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically
      well-controlled following their first course of treatment with omalizumab (150mg or 300mg).
      The study also assessed the benefit of uptitrating to 300mg dose in participants who were not
      well-controlled following their initial course of treatment with omalizumab 150mg, as well as
      the benefit of treatment extension of those patients who were not well-controlled following
      their initial course of treatment with omalizumab 300mg.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men or women at least 18 years of age at time of screening.

          -  Having a diagnosis of CSU and the presence of symptoms for ≥6 months prior to the
             screening visit.

          -  Presence of itch and hives for ≥6 consecutive weeks at any time prior to the screening
             visit despite concurrent use of non-sedating H1-antihistamine treatment

          -  Patient must have been on an approved dose of non-sedating H1-antihistamine for CSU,
             and no other concomitant CSU treatment, for at least the 7 consecutive days
             immediately prior to the randomization visit and must document current use on the day
             of the randomization visit.

        Key Exclusion Criteria:

          -  Patients having a clearly defined underlying etiology for chronic urticaria other than
             CSU including the following urticarias: acute, solar, cholinergic, heat, cold,
             aquagenic, delayed pressure or contact

          -  Patients with other skin disease associated with itch that could interfere with study
             outcomes and/or compromise the safety of the patient

          -  Patients with evidence of parasitic infection

          -  Patients with a history of malignancy of any organ system (other than localized basal
             cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless
             of whether there is evidence of local recurrence or metastases.

          -  Pregnant or nursing (lactating) women,

          -  Women of child-bearing potential, unless they are using effective methods of
             contraception during dosing of study treatment.

          -  Patients who are unable or unwilling to comply with study procedures, attend scheduled
             study visits, complete questionnaires and daily diaries, or who may otherwise be
             unable to comply with the study requirements.