Urticaria Facticia Treatment With Omalizumab (UFO)
Condition: Symptomatic Dermographism
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: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Urticaria is a very frequent skin condition characterized by transient wheal and flare type
      skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients
      are thought to suffer from persisting urticaria symptoms, which either occur spontaneously,
      i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental physical stimuli
      such as friction, pressure, UV irradiation or cold (physical urticaria). Urticaria factitia
      (also known as dermographic urticaria and symptomatic dermographism) is characterized by
      whealing and itching following a minor stroking pressure, rubbing or scratching of the skin.
      The majority of patients with urticaria factitia benefits from treatment with nonsedating
      antihistamines. Some patients, however, do not achieve adequate symptom control even with
      updosing of antihistamines and may suffer from substantial quality of life impairment . Since
      even very minor stroking of the skin can lead to the development of wheals and severe
      itching, these patients are for example limited in their choice of clothing and are impaired
      in their social interaction and partnership.

      In all patients with a history of wheals after stroking of the skin, a provocation test
      should be performed. This can be done by stroking of the skin lightly with a smooth blunt
      object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built
      instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the
      smooth blunt object should be held perpendicular to the skin and should be used to apply a
      light stroking pressure to the skin of the upper back or volar forearm. The reaction is
      considered positive in patients who show a weal response and report pruritus at the site of
      provocation.

      Patients with a positive test reaction should be evaluated for individual pressure
      thresholds. For this purpose a provocation device (FricTest) has been developed that allows
      for reproducible and standardized threshold testing. Threshold testing enables physicians to
      assess disease severity and treatment response more precisely.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (18-75 years)

          -  Informed consent signed and dated

          -  Able to read, understand and willing to sign the informed consent form and abide with
             study procedures

          -  Diagnosis of UF 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 4 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)