Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
Idiopathic Angioedema
About this trial
This is an interventional treatment trial for Idiopathic Angioedema focused on measuring Angioedema, Idiopathic Angioedema, IAE
Eligibility 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 intrauterine device (IUD), or double-barrier contraception (partner using condom and participant using diaphragm, contraceptive sponge or cervical cap, and spermicidal)
Exclusion Criteria:
- Diagnosis of Hereditary Angioedema (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
Sites / Locations
- UW Madison
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Omalizumab
Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.
Omalizumab is a sterile, white, preservative-free, lyophilized powder, contained in a single-use vial that will be reconstituted with sterile water for injection (SWFI), USP, and administered as a subcutaneous injection. Each omalizumab vial contains 202.5 mg of omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial is designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.