Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy

• Status: Completed
• Trial end date: 2020-01-06
• Target enrollment: 0
• Participant gender: All

Summary

The overall hospitalizations for a diagnosis of angioedema doubled from the year 2000 to 2009. Although some of the cases represented hereditary angioedema or ace-inhibitor induced angioedema, the majority of episodes were idiopathic. Idiopathic Angioedema (IAE) can be life- threatening especially when affecting tissues within the respiratory tract. No clear guidelines exist for management of this important condition for clinicians. Current therapies typically include avoidance of potential triggers and use of medications either for prophylaxis or for acute events, such as antihistamines, corticosteroids, and epinephrine. There remains a critical need for therapeutic options to provide more effective prophylaxis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Novartis Pharmaceuticals
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Adults or adolescents who are 18 years or older at the time of screening with physician diagnosis of idiopathic angioedema

• Minimum of two episodes of idiopathic angioedema in the past 6 months at the time of screening

• Management of idiopathic angioedema with a stable controller treatment plan for the prior 6 months

• Complement profile (C1 Esterase inhibitor panel) within normal reference values

• If a woman is of child-bearing potential, she must agree to a reliable form of birth control including: abstinence, oral contraceptives (birth control pills), Depo-provera, an IUD (intrauterine device), or double-barrier contraception (partner using condom and participant using diaphragm, contraceptive sponge or cervical cap, and spermicidal)

Exclusion Criteria:

• Diagnosis of HAE, Acquired Angioedema, or Ace-inhibitor associated angioedema, which are forms of angioedema with known mechanisms and alternate treatment options

• Chronic Urticaria (itching and/or hives) with or without Angioedema which are known mast cell mediated processes previously shown to be responsive to the use of omalizumab

• Previous usage of omalizumab in the last 3 months which can affect the patient-related outcomes and biomarker assessments if not "washed out" of the system

• Patients, who in the judgment of the investigator, have a history or condition that might compromise patient safety or compliance, interfere with evaluations, or preclude completion of the study