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Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy

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ClinicalTrials.gov Identifier: NCT02966314
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Idiopathic Angioedema Drug: Omalizumab Drug: Placebos Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection.
Drug: Placebos
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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

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


Contacts
Contact: Mary Jo Jackson, BSN 608-265-3556 mmj@medicine.wisc.edu
Contact: Tina Palas, BS 608-265-4554 tmp@medicine.wisc.edu

Locations
United States, Wisconsin
UW Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Mary Jo Jackson, G+BSN    608-265-3556    mmj@medicine.wisc.edu   
Contact: Tina Palas, BS    608-265-4554    tmp@medicine.wisc.edu   
Principal Investigator: Ravi Viswanathan, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Novartis Pharmaceuticals
Investigators
Principal Investigator: Sameer Mathur, MD/PhD UW Madison
Principal Investigator: Ravi Viswanathan, MD UW Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02966314     History of Changes
Other Study ID Numbers: 2016-0645
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
Angioedema
Idiopathic Angioedema
IAE

Additional relevant MeSH terms:
Urticaria
Angioedema
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents