Phase 4
Completed N=10
Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
Idiopathic Angioedema
Source: ClinicalTrials.gov NCT02966314 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Mean 7-day Angioedema Activity Score (AAS7) — 2.8; 1.6; 0.69; 0.20 score on a scale
◆ Published Evidence
Emerging
15citations · ~4 / year
Omalizumab for treatment of idiopathic angioedema.
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.
Linked Publications
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Omalizumab for treatment of idiopathic angioedema.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean 7-day Angioedema Activity Score (AAS7) |
2.8; 1.6; 0.69; 0.20 | — |
| PRIMARY Presence of a 7-day Angioedema Activity Score (AAS7) Greater Than 0 Across All Treatment Visits |
38; 4 | 0.003 sig |
| SECONDARY Mean Angioedema Quality of Life (AE-QoL) Questionnaire |
28.25; 21.47; 19.12; 8.53 | — |
| SECONDARY Mean Angioedema Quality of Life (AE-QoL) Questionnaire Across All Treatment Visits |
19.0; 8.5 | 0.03 sig |
| SECONDARY Mean Visual Analog Scale |
91; 84; 88.75; 97 | — |
| SECONDARY Presence of Visual Analog Scale Less Than 100 Across All Treatment Visits |
17; 4 | 0.03 sig |
| SECONDARY Mean Number of IAE Episodes 2 Weeks Prior to Randomization |
1; 0.4; 0.5; 0.2 | — |
| SECONDARY Number of IAE Events Across All Treatment Visits |
1.8; 0.2 | 0.005 sig |
| SECONDARY Change in Duration of IAE Episodes |
14.3; 21.1; 3.25; 0.5 | — |
| SECONDARY Number of Participants Who Visited Urgent Care or Emergency Room |
— | — |
| SECONDARY Number of Participants Who Used Rescue Medication or Corticosteroids |
— | — |
| SECONDARY Number of Times Rescue Medications Were Used During the Treatment Period |
5; 0; 13; 7; 14; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02966314) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.