rticaria facticia Treatment with Omalizumab

Phase 2

• Conditions: rticaria facticia; L50.3; Dermatographic urticaria

• Registration Number: DRKS00004643
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-21
• Study Completion: 2015-12-01
• Results First Posted: 2017-04-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

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 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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in provocation thresholds from baseline to day 70 in urticaria factitia patients after treatment with omalizumab compared to placebo.<br><br>During the visits, threshold will be assessed by using a standardised dermographometer, the Fric Test device.

Secondary Outcome Measures

Name	Time	Method
Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting<br>Change in quality of life scores, in number of symptom free days, and in physician and patient global assessment of disease severity from baseline to day 70 after treatment with omalizumab compared to placebo.<br>Long-term effects of omalizumab in UF patients on change in friction thresholds from day 70 (week 10) to day 112 (week 16).<br><br>quality of lifet: DLQI, disease activity (Patient and Investigator global assessment)