Cold Urticaria Treatment With Xolair
Condition: Cold Contact Urticaria
MeSH terms: Urticaria
Intervention: Omalizumab; Omalizumab; Placebo
Intervention description: 150mg, s.c., every 4 weeks; 300mg, s.c., every 4 weeks; Placebo, s.c., every 4 weeks
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Urticaria is a very frequent skin condition characterised by transient wheal and flare type
      skin reactions associated with severe pruritus. Cold contact urticaria (CCU) is a frequent
      form of physical urticaria that is characterized by the development of wheal and flare type
      skin reactions due to the release of histamine and other proinflammatory mast cell mediators
      following exposure of the skin to cold. Among all physical urticaria subtypes the frequency
      of CCU varies between 5.7% and 33.8% in different studies. Physical urticarias including CCU
      are known to severely impair the quality of life of affected patients.

      The treatment of choice in CCU, as well as in other inducible forms and spontaneous
      urticaria, are non-sedating H1 antihistamines. Recent data have shown that updosing of H1
      blockers is significantly more effective in reducing symptoms in cold urticaria than
      standard-dose treatment. Thus, patients who cannot be sufficiently controlled with
      standard-dose antihistamines should receive high-dose H1 blockers up to 4 times the standard
      dose as recommended by the new international guidelines for the management of urticaria.

      Previous phase II studies in patients with chronic spontaneous urticaria have shown favorable
      results for the treatment with omalizumab (Xolair®). Proof-of-concept data from completed
      studies suggest that omalizumab improves urticaria in patients with chronic spontaneous
      urticaria who have failed treatment with H1 antihistamines as well as those who have failed
      treatment with a combination of H1 and H2 antihistamines and a leukotriene receptor
      antagonist. In addition, two case reports of patients with severe therapy refractory CCU
      treated with omalizumab reported a complete response with no urticarial symptoms after cold
      challenge. In summary, these data suggest that omalizumab may have a beneficial effect in the
      treatment of CCU.
    

Eligibility criteria:

        Inclusion Criteria:

        Adults (18 years or older) Informed consent signed and dated Able to read, understand and
        willing to sign the informed consent form and abide with study procedures Diagnosis of CCU
        lasting for at least 6 months Willing, committed and able to return for all clinic visits
        and complete all study-related procedures, including willingness to have SC injections
        administered by a qualified person In females of childbearing potential: Negative pregnancy
        test; females willing to use highly effective contraception (Pearl-Index < 1). A woman will
        be considered not of childbearing potential if she is post-menopausal for greater than two
        years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
        hysterectomy) No participation in other clinical trials 4 weeks before and after
        participation in this study

        Exclusion Criteria:

        Patients with acute urticaria Concurrent/ongoing treatment with immunosuppressives (e.g.
        systemic steroids, cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half
        lives prior to day 0, whichever is longer Significant medical condition rendering the
        patient immunocompromised or not suitable for a clinical trial Significant concomitant
        illness that would adversely affect the subject's participation or evaluation in this study
        History of malignancies within five years prior to screening other than a successfully
        treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
        Presence of clinically significant laboratory abnormalities Lactating females or pregnant
        females Subjects for whom there is concern about compliance with the protocol procedures
        Any medical condition which, in the opinion of the Investigator, would interfere with
        participation in the study or place the subject at risk History of substance abuse (drug or
        alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years
        that could limit the subject's ability to comply with study procedures Subjects who are
        detained officially or legally to an official institute Previous use of omalizumab within
        the last 6 months Intake of antihistamines or leukotriene antagonists within 7 days prior
        to visit 1 Intake of oral corticosteroids within 14 days prior to visit 1 Use of depot
        corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the
        study Known hypersensitivity to any ingredients, including excipients (sucrose, histidine,
        polysorbate 20) of the study medication or drugs related to omalizumab (e.g.: monoclonal
        antibodies, polyclonal gammaglobulin)