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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. Identifier: NCT02966314
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : November 19, 2019
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE November 15, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE March 30, 2017
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02966314 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
Quality of Life [ Time Frame: 9 months ]
To estimate the effect of omalizumab in improving quality of life in idiopathic angioedema subjects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
Official Title  ICMJE 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
Brief 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.
Detailed Description This study is a randomized, double-blind, placebo-controlled, parallel group trial which will study the effects of omalizumab on patients with 2 or more episodes of Idiopathic Angioedema (IAE) in the past 6 months, despite current therapy. This study has three periods; screening, treatment, and follow-up. Subjects in the screening period will be consented and screened for eligibility criteria. 40 qualified individuals will enter the treatment period. Individuals will be randomized to either monthly subcutaneous administration of omalizumab 300mg (20 subjects) versus monthly placebo injection (20 subjects) in addition to their previously prescribed management plan for a total of 6 months. Individuals will then enter a follow-up period of 4 months. Study visits will occur monthly during the treatment period for update of clinical status and administration of omalizumab/placebo injection. After, the treatment period individuals will be seen twice for follow-up period. The entire study will consist of 10 study visits and will last approx. 10 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Angioedema
Intervention  ICMJE
  • Drug: Omalizumab
    Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections.
    Other Name: Xolair
  • Drug: Placebos
    Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months.
    Other Name: Control
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.
    Intervention: Drug: Placebos
  • 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.
    Intervention: Drug: Omalizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2016)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2020
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 at the time of screening, which will include patients managed using the following approaches:

    • No prophylaxis and only use of on demand medications for episodes of idiopathic angioedema
    • Use of prophylactic medications and additional on demand medications for episodes of idiopathic angioedema
  • Body Mass Index less than or equal to 50 at the time of screening visit.
  • Complement C4 and C1 inhibitor panel within normal reference ranges.
  • 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 subject using diaphragm).

Exclusion Criteria:

  • Unable to give informed written consent, unable to adhere to the outlined visit schedule or unable to tolerate the procedures required for participation in this trial.
  • Unable, in the judgment of the investigator, to comply with study procedures and/ or directions.
  • Treatment with an investigational agent within 30 days of the screening visit.
  • Medical examination or laboratory findings that may suggest neoplasms, malignancies, or a history of malignancies.
  • Nursing mothers, pregnant women, or women of childbearing potential who are planning a pregnancy during the course of the study.
  • Any history of life-threatening angioedema which affects breathing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Jo Jackson, BSN 608-265-3556
Contact: Tina Palas, BS 608-265-4554
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02966314
Other Study ID Numbers  ICMJE 2016-0645
SMPH/MEDICINE/MEDICINE*A ( Other Identifier: UW, Madison )
A534220 ( Other Identifier: UW, Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Sameer Mathur, MD/PhD UW Madison
Principal Investigator: Ravi Viswanathan, MD UW Madison
PRS Account University of Wisconsin, Madison
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP