Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02966314|
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Angioedema||Drug: Omalizumab Drug: Placebos||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Phase IV, Randomized, Double-Blind, Placebo-Controlled Exploratory Study of Xolair (Omalizumab) for Treatment of Idiopathic Angioedema in Patients Who Remain Symptomatic Despite Current Therapy|
|Actual Study Start Date :||March 30, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Placebo Comparator: Placebo
Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.
Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months.
Other Name: Control
Active Comparator: Omalizumab
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.
Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections.
Other Name: Xolair
- Number of angioedema episodes [ Time Frame: 9 months ]To estimate the effect of omalizumab in reducing the severity of angioedema episodes in patients with idiopathic angioedema
- Quality of Life [ Time Frame: 9 months ]To estimate the effect of omalizumab in improving quality of life in idiopathic angioedema subjects using the Quality of Life Questionnaire for Patients with Recurrent Swelling Episodes (AE-QOL).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966314
|Contact: Mary Jo Jackson, BSNfirstname.lastname@example.org|
|Contact: Tina Palas, BSemail@example.com|
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Contact: Mary Jo Jackson, G+BSN 608-265-3556 firstname.lastname@example.org|
|Contact: Tina Palas, BS 608-265-4554 email@example.com|
|Principal Investigator: Ravi Viswanathan, MD|
|Principal Investigator:||Sameer Mathur, MD/PhD||UW Madison|
|Principal Investigator:||Ravi Viswanathan, MD||UW Madison|