Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/MEDICINE/MEDICINE*A | Other Identifier | UW Madison | |
| A534220 | Other Identifier | UW Madison | |
| Protocol Version 5/22/2018 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection. |
|
| Omalizumab | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 7-day Angioedema Activity Score (AAS7) | The AAS7 Score is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. | baseline to end of treatment period at 6 months |
| Presence of a 7-day Angioedema Activity Score (AAS7) Greater Than 0 Across All Treatment Visits | The AAS7 Score is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. | across all visits during treatment period (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Angioedema Quality of Life (AE-QoL) Questionnaire | The AE-QoL Questionnaire is a 17-item survey, the total possible range of scores is transformed to a scale of 1-100 where higher score indicate increased impairment. | baseline to end of treatment period at 6 months |
| Mean Angioedema Quality of Life (AE-QoL) Questionnaire Across All Treatment Visits |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sameer Mathur, MD/PhD | UW Madison | Principal Investigator |
| Ravi Viswanathan, MD | UW Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Madison | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35914662 | Result | Goswamy VP, Lee KE, McKernan EM, Fichtinger PS, Mathur SK, Viswanathan RK. Omalizumab for treatment of idiopathic angioedema. Ann Allergy Asthma Immunol. 2022 Nov;129(5):605-611.e1. doi: 10.1016/j.anai.2022.07.017. Epub 2022 Jul 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two participants were screened and enrolled but not randomized to an arm to start the study.
Participants were screened and enrolled at the University of Wisconsin-Madison Allergy and Asthma Clinical Research Unit from March 2017 to April 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection. Placebos: Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months. |
| FG001 | 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: Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two participants enrolled onto the study were screened but not randomized to an arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection. Placebos: Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months. |
| BG001 | Omalizumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean 7-day Angioedema Activity Score (AAS7) | The AAS7 Score is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. | Posted | Mean | Full Range | score on a scale | baseline to end of treatment period at 6 months |
|
up to 9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo contains sodium chloride 0.9% and will be provided by Novartis. Placebo will be administered as a subcutaneous injection. Placebos: Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Injection Site Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravi Viswanathan | University of Wisconsin - Madison | (608) 263-1081 | rviswanathan@medicine.wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2018 | Aug 5, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebos | Drug | Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months. |
|
The AE-QoL Questionnaire is a 17-item survey, the total possible range of scores is transformed to a scale of 1-100 where higher score indicate increased impairment. |
| across all visits during treatment period (up to 6 months) |
| Mean Visual Analog Scale | The effect of treatment compared to placebo on the change in IAE severity from baseline to the end of the treatment period as recorded on a 0-100 visual analog scale. Lower numbers indicate increased severity. | baseline to end of treatment period at 6 months |
| Presence of Visual Analog Scale Less Than 100 Across All Treatment Visits | The effect of treatment compared to placebo on the change in IAE severity from baseline to the end of the treatment period as recorded on a 0-100 visual analog scale. Lower numbers indicate increased severity. | across all visits during treatment period (up to 6 months) |
| Mean Number of IAE Episodes 2 Weeks Prior to Randomization | Idiopathic angioedema (IAE) refers to episodes of angioedema without urticaria for which no explanation can be found despite a thorough investigation. Patients are sometimes referred to as having IAE while further investigations are being performed, and therefore this term does not necessarily represent a distinct condition, but rather a diagnostic challenge in which the pathway of swelling is yet to be determined. | baseline to end of treatment period at 6 months |
| Number of IAE Events Across All Treatment Visits | across all visits during treatment period (up to 6 months) |
| Change in Duration of IAE Episodes | Duration of IAE Episodes is participant reported for the 6 months prior to study (baseline) and again at the 6 month time point for the time on study. | baseline to end of treatment period at 6 months |
| Number of Participants Who Visited Urgent Care or Emergency Room | Count of participants who visited urgent care or the emergency room is participant reported. The baseline measure is for the 6 months prior to study, at the 6 month time point for the time on study, and the 9 month time point for the previous 3 months on study. | baseline, end of treatment period at 6 months, follow up at 9 months |
| Number of Participants Who Used Rescue Medication or Corticosteroids | baseline, end of treatment period at 6 months, follow up at 9 months |
| Number of Times Rescue Medications Were Used During the Treatment Period | up to 26 weeks |
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: Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Full Range | centimeters |
|
| Weight | Mean | Full Range | kg |
|
| Number of IAE Episodes in past 6 months | Idiopathic Angioedema (IAE) | Mean | Full Range | IAE Episodes |
|
| Duration of IAE Episodes | Average number of hours that each IAE event lasted over the previous month, as reported by participant at baseline | Mean | Full Range | hours |
|
| Number of Urgent Care / Emergency Department Visits in past 6 months | Mean | Full Range | visits |
|
|
|
| Primary | Presence of a 7-day Angioedema Activity Score (AAS7) Greater Than 0 Across All Treatment Visits | The AAS7 Score is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. | Posted | Count of Units | participant visits | across all visits during treatment period (up to 6 months) | participant visits | participant visits |
|
|
|
|
| Secondary | Mean Angioedema Quality of Life (AE-QoL) Questionnaire | The AE-QoL Questionnaire is a 17-item survey, the total possible range of scores is transformed to a scale of 1-100 where higher score indicate increased impairment. | 1 participant in the placebo arm was lost to follow up at the 6 month measure, but was able to be analyzed for the Primary Outcome | Posted | Mean | Full Range | score on a scale | baseline to end of treatment period at 6 months |
|
|
|
| Secondary | Mean Angioedema Quality of Life (AE-QoL) Questionnaire Across All Treatment Visits | The AE-QoL Questionnaire is a 17-item survey, the total possible range of scores is transformed to a scale of 1-100 where higher score indicate increased impairment. | Posted | Mean | Standard Deviation | score on a scale | across all visits during treatment period (up to 6 months) | participant visits | participant visits |
|
|
|
|
| Secondary | Mean Visual Analog Scale | The effect of treatment compared to placebo on the change in IAE severity from baseline to the end of the treatment period as recorded on a 0-100 visual analog scale. Lower numbers indicate increased severity. | 1 participant in the placebo arm was lost to follow up at the 6 month measure, but was able to be analyzed for the Primary Outcome | Posted | Mean | Full Range | score on a scale | baseline to end of treatment period at 6 months |
|
|
|
| Secondary | Presence of Visual Analog Scale Less Than 100 Across All Treatment Visits | The effect of treatment compared to placebo on the change in IAE severity from baseline to the end of the treatment period as recorded on a 0-100 visual analog scale. Lower numbers indicate increased severity. | Posted | Count of Units | participant visits | across all visits during treatment period (up to 6 months) | participant visits | participant visits |
|
|
|
|
| Secondary | Mean Number of IAE Episodes 2 Weeks Prior to Randomization | Idiopathic angioedema (IAE) refers to episodes of angioedema without urticaria for which no explanation can be found despite a thorough investigation. Patients are sometimes referred to as having IAE while further investigations are being performed, and therefore this term does not necessarily represent a distinct condition, but rather a diagnostic challenge in which the pathway of swelling is yet to be determined. | 1 participant in the placebo arm was lost to follow up at the 6 month measure, but was able to be analyzed for the Primary Outcome | Posted | Mean | Full Range | episodes | baseline to end of treatment period at 6 months |
|
|
|
| Secondary | Number of IAE Events Across All Treatment Visits | Posted | Mean | Standard Deviation | count of events | across all visits during treatment period (up to 6 months) | participant visits | participant visits |
|
|
|
|
| Secondary | Change in Duration of IAE Episodes | Duration of IAE Episodes is participant reported for the 6 months prior to study (baseline) and again at the 6 month time point for the time on study. | 1 participant in the placebo arm was lost to follow up at the 6 month measure, but was able to be analyzed for the Primary Outcome | Posted | Mean | Full Range | hours | baseline to end of treatment period at 6 months |
|
|
|
| Secondary | Number of Participants Who Visited Urgent Care or Emergency Room | Count of participants who visited urgent care or the emergency room is participant reported. The baseline measure is for the 6 months prior to study, at the 6 month time point for the time on study, and the 9 month time point for the previous 3 months on study. | Data not collected due to study communications. | Posted | baseline, end of treatment period at 6 months, follow up at 9 months |
|
|
|
| Secondary | Number of Participants Who Used Rescue Medication or Corticosteroids | Data not collected due to study communications. | Posted | baseline, end of treatment period at 6 months, follow up at 9 months |
|
|
| Secondary | Number of Times Rescue Medications Were Used During the Treatment Period | Posted | Count of Units | instances of rescue medication use | No | up to 26 weeks | instances of rescue medication use | instances of rescue medication use |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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: Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections. | 0 | 5 | 0 | 5 | 1 | 5 |
Not provided
Not provided
Not provided
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 6 months |
|
|
| 6 months |
|
|
| 6 months |
|
|
| 6 months |
|
|
| Number of times rescue H2-antagonist used |
|