Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/26/2019 |
| Start Date: | March 30, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Mary Jo Jackson, BSN |
| Email: | mmj@medicine.wisc.edu |
| Phone: | 608-265-3556 |
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
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.
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.
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 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.
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.
We found this trial at
1
site
Madison, Wisconsin 53705
Principal Investigator: Ravi Viswanathan, MD
Phone: 608-265-3556
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