Cold Urticaria Treatment With Xolair (CUTEX)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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)|
- Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo [ Time Frame: day 70 ] [ Designated as safety issue: No ]The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.
- Safety of Patients Treated With Omalizumab: This Includes Physical Examination, Routine Safety Laboratory Assessments, Vital Signs and Adverse Event Reporting [ Time Frame: day 70 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Study Completion Date:||February 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Omalizumab 150mg||
150mg, s.c., every 4 weeks
Other Name: Xolair
|Experimental: Omalizumab 300mg||
300mg, s.c., every 4 weeks
Other Name: Xolair
|Placebo Comparator: Placebo||
Placebo, s.c., every 4 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580592
|Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Principal Investigator:||Martin Metz, MD||Charité|