Clinical Trials Logo

Clinical Trial Summary

This study is being done to find out if a drug called Xolair (omalizumab), an anti-IgE antibody, is safe and effective for people with chronic urticaria (hives) with persistent symptoms in spite of taking antihistamines.


Clinical Trial Description

Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that binds specifically to the FcEpsilonR1 binding site on human IgE. The binding of omalizumab inhibits the ability of IgE to bind to basophils or mast cells. Free IgE levels fall by 89% and 98% over 16 and 24 weeks of therapy respectively (Busse, 2001). Total IgE levels rise in patients treated with omalizumab though almost all IgE is bound and thus inactive. Omalizumab has also been shown to decrease expression of the FcEpsilonR1 receptor on both basophils and mast cells (Beck et al, 2004). Omalizumab recently received FDA approval for the treatment of moderate to severe persistent allergic asthma in pediatric (12 years of age and above) and adult patients. Studies have also shown efficacy in the treatment of allergic rhinitis and similar anti-IgE compounds have been efficacious as food allergy therapeutics (Casale, 2001, and Leung 2003).

Given the efficacy of omalizumab in the treatment of moderate to severe allergic asthma, the researchers will conduct a double-blind study to evaluate the safety and efficacy of omalizumab in a small number of patients with chronic urticaria with persistent symptoms in spite of background antihistamine therapy. Omalizumab is currently not indicated for patients with chronic urticaria. The primary hypothesis is that omalizumab will lead to a reduction in serum IgE levels and blood basophil high affinity IgE receptor expression in subjects with chronic idiopathic urticaria. Additionally, clinical outcomes such as quality of life, symptoms scores, and medication use will be explored. This study should allow for further understanding of the role IgE plays in chronic urticaria. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00130234
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 2
Start date November 2004
Completion date September 2007

See also
  Status Clinical Trial Phase
Terminated NCT03693625 - A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study Phase 2
Recruiting NCT03545464 - COrticosteroids in acUte uRticAria in emerGency dEpartment Phase 3
Completed NCT00541255 - A Long-Term Examination of Asthma From Childhood Through Adolescence
Not yet recruiting NCT00163839 - The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema N/A
Terminated NCT00069329 - Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease N/A
Completed NCT00876369 - Vitamin D Levels in Subjects With Chronic Urticaria and Angioedema
Terminated NCT00199238 - Efficacy of Rupatadine 5, 10 and 20 mg in Chronic Idiopathic Urticaria Phase 2
Completed NCT02576041 - Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria Phase 4
Completed NCT00724698 - Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Completed NCT02238249 - Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria N/A
Completed NCT00001150 - Induction of Suction Blisters in Patients With Urticaria, Blistering Diseases, Inflammatory Dermatoses and Neoplastic Disorders, and in Normal Volunteers N/A
Completed NCT03296358 - Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines in Emergency Department. N/A
Completed NCT00795158 - How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988) Phase 3
Completed NCT00368823 - A Trial of Point of Care Information in Ambulatory Pediatrics Phase 3
Completed NCT02424799 - Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264 Phase 1
Completed NCT01371877 - The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment N/A
Completed NCT00751218 - A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735) Phase 4
Completed NCT03137069 - A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU). Phase 2
Recruiting NCT05115136 - Using Doxepin for Urticaria Phase 3
Terminated NCT02382562 - Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients N/A