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Cold Urticaria Treatment With Xolair (CUTEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580592
Recruitment Status : Completed
First Posted : April 19, 2012
Results First Posted : February 15, 2016
Last Update Posted : April 7, 2017
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Martin Metz, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE April 18, 2012
First Posted Date  ICMJE April 19, 2012
Results First Submitted Date  ICMJE October 27, 2015
Results First Posted Date  ICMJE February 15, 2016
Last Update Posted Date April 7, 2017
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo [ Time Frame: day 70 ]
The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2012)
Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo [ Time Frame: day 70 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events [ Time Frame: day 70 ]
This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2012)
Safety of Patients Treated With Omalizumab: This Includes Physical Examination, Routine Safety Laboratory Assessments, Vital Signs and Adverse Event Reporting [ Time Frame: day 70 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Cold Urticaria Treatment With Xolair
Official Title  ICMJE A Two-center, Double Blind, Placebo-controlled Study in Parallel Design to Assess the Efficacy and Safety of 150 and 300 mg Omalizumab in Subjects With Antihistamine-resistant Cold Contact Urticaria (CCU)
Brief Summary

Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus. Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Among all physical urticaria subtypes the frequency of CCU varies between 5.7% and 33.8% in different studies. Physical urticarias including CCU are known to severely impair the quality of life of affected patients.

The treatment of choice in CCU, as well as in other inducible forms and spontaneous urticaria, are non-sedating H1 antihistamines. Recent data have shown that updosing of H1 blockers is significantly more effective in reducing symptoms in cold urticaria than standard-dose treatment. Thus, patients who cannot be sufficiently controlled with standard-dose antihistamines should receive high-dose H1 blockers up to 4 times the standard dose as recommended by the new international guidelines for the management of urticaria.

Previous phase II studies in patients with chronic spontaneous urticaria have shown favorable results for the treatment with omalizumab (Xolair®). Proof-of-concept data from completed studies suggest that omalizumab improves urticaria in patients with chronic spontaneous urticaria who have failed treatment with H1 antihistamines as well as those who have failed treatment with a combination of H1 and H2 antihistamines and a leukotriene receptor antagonist. In addition, two case reports of patients with severe therapy refractory CCU treated with omalizumab reported a complete response with no urticarial symptoms after cold challenge. In summary, these data suggest that omalizumab may have a beneficial effect in the treatment of CCU.

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 Cold Contact Urticaria
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 * Metz M, Schütz A, Weller K, Gorczyza M, Zimmer S, Staubach P, Merk HF, Maurer M. Omalizumab is effective in cold urticaria-results of a randomized placebo-controlled trial. J Allergy Clin Immunol. 2017 Sep;140(3):864-867.e5. doi: 10.1016/j.jaci.2017.01.043. Epub 2017 Apr 4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2012)
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Adults (18 years or older) Informed consent signed and dated Able to read, understand and willing to sign the informed consent form and abide with study procedures Diagnosis of CCU 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)

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 NCT01580592
Other Study ID Numbers  ICMJE CIGE025EDE14T
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
PRS Account Charite University, Berlin, Germany
Verification Date February 2017

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