Urticaria Facticia Treatment With Omalizumab (UFO)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02169115
• Date of registration: 12/06/2014
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Urticaria Facticia Treatment With Omalizumab (UFO) UFO
• Scientific title: Double-blind, Placebo-controlled 12-week, Parallel-group Study With a 6 Weeks Follow up Period to Demonstrate Efficacy and Safety of Subcutaneous Omalizumab in Patients With Urticaria Factitia Refractory to Standard Treatment
• Date of first enrolment: December 2012
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02169115
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Martin Metz, MD
• Affiliation: Charité University

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Symptomatic Dermographism

Intervention(s)

Drug: Placebo

Drug: Omalizumab

Primary Outcome(s)

Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo [Time Frame: 70 days]

Secondary Outcome(s)

To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days [Time Frame: 70 days]

To Assess Long-term Effects of Omalizumab in UF Patients [Time Frame: 112 days]

Number of Participants With Serious Adverse Events and Adverse Events [Time Frame: 112 days]

To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life [Time Frame: 70 days]

To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity [Time Frame: 70 days]

To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity [Time Frame: 70 days]

Secondary ID(s)

2011-005615-87

CIGE025EDE17T

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 18/01/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02169115