Urticaria factitia MedDRA version: 16.0 Level: LLT Classification code 10012499 Term: Dermatographic urticaria System Organ Class: 100000004858
Conditions
Sponsors
Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion 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 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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of 150 and 300 mg omalizumab on wheal development in UF patients ;Secondary Objective: To assess the safety of omalizumab in subjects with UF To assess the effects of omalizumab in UF patients on quality of life, on number of symptom free days, on physician global assessment of disease severity, on patient global assessment of disease severity To assess long-term effects of omalizumab in UF patients ;Primary end point(s): Change in critical friction thresholds from baseline to day 70 after treatment with omalizumab compared to placebo. ;Timepoint(s) of evaluation of this end point: day 70 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess the safety of omalizumab in subjects with UF • To assess the effects of omalizumab in UF patients on quality of life, on number of symptom free days, on physician global assessment of disease severity, on patient global assessment of disease severity • To assess long-term effects of omalizumab in UF patients ;Timepoint(s) of evaluation of this end point: Day 28, 56, 70, 112 | — |
Countries
Germany
Contacts
Public ContactHesna Gözlükaya
Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin
Outcome results
None listed