Cold contact urticaria MedDRA version: 15.1 Level: PT Classification code 10009869 Term: Cold urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Allergie-Centrum-Charité, Department of Dermatology and Allergy, 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 • CCU diagnosis based on positive cold stimulation test by TEMPTest 3.0 • 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: • 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 critical temperature thresholds (CTT) in CCU patients challenged with defined temperatures using TEMPTest 3.0.;Secondary Objective: To assess the effects of 150 and 300 mg omalizumab on critical stimulation time thresholds (CSTT) in CCU patients using TEMPTest 3.0. To assess the safety of omalizumab in subjects with CCU ;Primary end point(s): Change in critical temperature thresholds (CTT) from baseline to day 70 after treatment with omalizumab compared to placebo. ;Timepoint(s) of evaluation of this end point: after 10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting;Timepoint(s) of evaluation of this end point: after 10 weeks | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin
Outcome results
None listed