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Urticaria Facticia Treatment With Omalizumab (UFO) (UFO)

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ClinicalTrials.gov Identifier: NCT02169115
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : January 18, 2016
Last Update Posted : December 20, 2016
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Martin Metz, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE June 20, 2014
Results First Submitted Date  ICMJE October 28, 2015
Results First Posted Date  ICMJE January 18, 2016
Last Update Posted Date December 20, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2015)
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo [ Time Frame: 70 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo [ Time Frame: 70 days ]
Patients receive provocation test by FricTest (standardized stroking of the skin). The development of wheals within 30 minutes after provocation is monitored.
Change History Complete list of historical versions of study NCT02169115 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
  • To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life [ Time Frame: 70 days ]
    Change in quality of life scores assessed by Dermatology Life Quality Index (DLQI) and UF specific life quality questions from baseline to day 70 after treatment with omalizumab compared to placebo.
  • To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days [ Time Frame: 70 days ]
    Change in number of symptom free days as assessed by a patient diary from baseline to day 70 after treatment with omalizumab compared to placebo
  • To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity [ Time Frame: 70 days ]
    Change in physician global assessment of disease severity assessed by visual analogue scale by a physician from baseline to day 70 after treatment with omalizumab compared to placebo.
  • To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity [ Time Frame: 70 days ]
    Change in patient global assessment of disease severity assessed by visual analogue scale by the patient from baseline to day 70 after treatment with omalizumab compared to placebo.
  • To Assess Long-term Effects of Omalizumab in UF Patients [ Time Frame: 112 days ]
    To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed
  • To Assess the Safety of Omalizumab in UF Patients [ Time Frame: 112 days ]
    Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Urticaria Facticia Treatment With Omalizumab (UFO)
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Symptomatic Dermographism
Intervention  ICMJE
  • Drug: Omalizumab
    150mg, s.c., every 4 weeks
    Other Name: Xolair
  • Drug: Omalizumab
    300mg, s.c., every 4 weeks
    Other Name: Xolair
  • Drug: Placebo
    Placebo, s.c., every 4 weeks
Study Arms  ICMJE
  • Experimental: Omalizumab 150mg
    Intervention: Drug: Omalizumab
  • Experimental: Omalizumab 300mg
    Intervention: Drug: Omalizumab
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Maurer M, Schütz A, Weller K, Schoepke N, Peveling-Oberhag A, Staubach P, Müller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2015)
61
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
60
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169115
Other Study ID Numbers  ICMJE CIGE025EDE17T
2011-005615-87 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Metz, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Martin Metz, MD Charité University
PRS Account Charite University, Berlin, Germany
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP