Urticaria Facticia Treatment With Omalizumab (UFO)

NCT02169115 | Completed Phase 2 Results

• 2 other identifiers: CIGE025EDE17T2011-005615-87
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Symptomatic Dermographism

Outcome Measures

Primary Outcomes (1)

• Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo

  Patients receive provocation test by FricTest (standardized stroking of the skin). FricTest ratings are from 0 (no wheal development to the longest pin) to 4 (wheal development to all four pins). The development of wheals within 30 minutes after provocation is monitored.

  70 days

Secondary Outcomes (6)

• To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life

  70 days

• To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days

  70 days

• To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity

  70 days

• To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity

  70 days

• To Assess Long-term Effects of Omalizumab in UF Patients

  112 days

Study Arms (3)

Omalizumab 150mg

EXPERIMENTAL

Drug: Omalizumab

Omalizumab 300mg

EXPERIMENTAL

Drug: Omalizumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Omalizumab DRUG

150mg, s.c., every 4 weeks

Also known as: Xolair

Omalizumab 150mg

Placebo DRUG

Placebo, s.c., every 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (2)

University Dermatology Freiburg

Freiburg im Breisgau, 79104, Germany

Location

Dermatology University Mainz

Mainz, 55131, Germany

Location

Related Publications (1)

• Maurer M, Schutz A, Weller K, Schoepke N, Peveling-Oberhag A, Staubach P, Muller S, Jakob T, Metz M. Omalizumab is effective in symptomatic dermographism-results of a randomized placebo-controlled trial. J Allergy Clin Immunol. 2017 Sep;140(3):870-873.e5. doi: 10.1016/j.jaci.2017.01.042. Epub 2017 Apr 4. No abstract available.

  PMID: 28389391 DERIVED

MeSH Terms

Conditions

Familial dermographism

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Professor Martin Metz
• Organization: Charité- Dpt. of Dermatology and Allergy

martin.metz@charite.de

+49 30 450 518 159

Study Officials

• Martin Metz, MD

  Charité University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 20, 2014
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 3, 2020
• Results First Posted: January 18, 2016

Record last verified: 2020-10

Locations

DE (2)