Urticaria Facticia Treatment With Omalizumab (UFO)

Charité University Medicine Berlin

Status and phase

Completed

Phase 2

Conditions

Symptomatic Dermographism

Treatments

Drug: Omalizumab

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02169115

CIGE025EDE17T

2011-005615-87 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)