Trial Outcomes & Findings for Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy (NCT NCT02966314)
NCT ID: NCT02966314
Last Updated: 2022-11-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
baseline to end of treatment period at 6 months
Results posted on
2022-11-01
Participant Flow
Participants were screened and enrolled at the University of Wisconsin-Madison Allergy and Asthma Clinical Research Unit from March 2017 to April 2019.
Two participants were screened and enrolled but not randomized to an arm to start the study.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
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.
|
Omalizumab
n=5 Participants
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.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
53 years
n=99 Participants
|
53.8 years
n=107 Participants
|
53.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Height
|
171.18 centimeters
n=99 Participants
|
180.86 centimeters
n=107 Participants
|
176.02 centimeters
n=206 Participants
|
|
Weight
|
93.4 kg
n=99 Participants
|
91.2 kg
n=107 Participants
|
92.3 kg
n=206 Participants
|
|
Number of IAE Episodes in past 6 months
|
15.2 IAE Episodes
n=99 Participants
|
10.6 IAE Episodes
n=107 Participants
|
12.9 IAE Episodes
n=206 Participants
|
|
Duration of IAE Episodes
|
14.3 hours
n=99 Participants
|
21.1 hours
n=107 Participants
|
17.7 hours
n=206 Participants
|
|
Number of Urgent Care / Emergency Department Visits in past 6 months
|
0.6 visits
n=99 Participants
|
0.2 visits
n=107 Participants
|
0.4 visits
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline to end of treatment period at 6 monthsThe 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.
Outcome measures
| Measure |
Placebo
n=5 Participants
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.
|
Omalizumab
n=5 Participants
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.
|
|---|---|---|
|
Mean 7-day Angioedema Activity Score (AAS7)
baseline (2 weeks prior to randomization)
|
2.8 score on a scale
Interval 0.0 to 9.0
|
1.6 score on a scale
Interval 0.0 to 4.0
|
|
Mean 7-day Angioedema Activity Score (AAS7)
6 months
|
0.69 score on a scale
Interval 0.0 to 1.75
|
0.20 score on a scale
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: across all visits during treatment period (up to 6 months)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.
Outcome measures
| Measure |
Placebo
n=103 participant visits
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.
|
Omalizumab
n=120 participant visits
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.
|
|---|---|---|
|
Presence of a 7-day Angioedema Activity Score (AAS7) Greater Than 0 Across All Treatment Visits
|
38 participant visits
|
4 participant visits
|
SECONDARY outcome
Timeframe: baseline to end of treatment period at 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Placebo
n=5 Participants
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.
|
Omalizumab
n=5 Participants
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.
|
|---|---|---|
|
Mean Angioedema Quality of Life (AE-QoL) Questionnaire
baseline (2 weeks prior to randomization)
|
28.25 score on a scale
Interval 4.41 to 42.65
|
21.47 score on a scale
Interval 0.0 to 42.65
|
|
Mean Angioedema Quality of Life (AE-QoL) Questionnaire
6 months
|
19.12 score on a scale
Interval 2.94 to 35.29
|
8.53 score on a scale
Interval 0.0 to 23.53
|
SECONDARY outcome
Timeframe: across all visits during treatment period (up to 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.
Outcome measures
| Measure |
Placebo
n=28 participant visits
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.
|
Omalizumab
n=30 participant visits
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.
|
|---|---|---|
|
Mean Angioedema Quality of Life (AE-QoL) Questionnaire Across All Treatment Visits
|
19.0 score on a scale
Standard Deviation 12.9
|
8.5 score on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: baseline to end of treatment period at 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Placebo
n=5 Participants
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.
|
Omalizumab
n=5 Participants
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.
|
|---|---|---|
|
Mean Visual Analog Scale
baseline (2 weeks prior to randomization)
|
91 score on a scale
Interval 70.0 to 100.0
|
84 score on a scale
Interval 30.0 to 100.0
|
|
Mean Visual Analog Scale
6 months
|
88.75 score on a scale
Interval 65.0 to 100.0
|
97 score on a scale
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: across all visits during treatment period (up to 6 months)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.
Outcome measures
| Measure |
Placebo
n=28 participant visits
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.
|
Omalizumab
n=30 participant visits
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.
|
|---|---|---|
|
Presence of Visual Analog Scale Less Than 100 Across All Treatment Visits
|
17 participant visits
|
4 participant visits
|
SECONDARY outcome
Timeframe: baseline to end of treatment period at 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Placebo
n=5 Participants
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.
|
Omalizumab
n=5 Participants
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.
|
|---|---|---|
|
Mean Number of IAE Episodes 2 Weeks Prior to Randomization
baseline (2 weeks prior to randomization)
|
1 episodes
Interval 0.0 to 4.0
|
0.4 episodes
Interval 0.0 to 1.0
|
|
Mean Number of IAE Episodes 2 Weeks Prior to Randomization
6 months
|
0.5 episodes
Interval 0.0 to 1.0
|
0.2 episodes
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: across all visits during treatment period (up to 6 months)Outcome measures
| Measure |
Placebo
n=28 participant visits
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.
|
Omalizumab
n=30 participant visits
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.
|
|---|---|---|
|
Number of IAE Events Across All Treatment Visits
|
1.8 count of events
Standard Deviation 2.3
|
0.2 count of events
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: baseline to end of treatment period at 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Placebo
n=5 Participants
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.
|
Omalizumab
n=5 Participants
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.
|
|---|---|---|
|
Change in Duration of IAE Episodes
baseline (2 weeks prior to randomization)
|
14.3 hours
Interval 2.0 to 36.0
|
21.1 hours
Interval 6.0 to 48.0
|
|
Change in Duration of IAE Episodes
6 months
|
3.25 hours
Interval 0.0 to 7.0
|
0.5 hours
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: baseline, end of treatment period at 6 months, follow up at 9 monthsPopulation: Data not collected due to study communications.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, end of treatment period at 6 months, follow up at 9 monthsPopulation: Data not collected due to study communications.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 26 weeksOutcome measures
| Measure |
Placebo
n=32 instances of rescue medication use
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.
|
Omalizumab
n=8 instances of rescue medication use
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.
|
|---|---|---|
|
Number of Times Rescue Medications Were Used During the Treatment Period
Number of times Rescue Systemic Steroid used
|
5 instances of rescue medication use
|
0 instances of rescue medication use
|
|
Number of Times Rescue Medications Were Used During the Treatment Period
Number of times rescue H1-antagonist used
|
13 instances of rescue medication use
|
7 instances of rescue medication use
|
|
Number of Times Rescue Medications Were Used During the Treatment Period
Number of times rescue H2-antagonist used
|
14 instances of rescue medication use
|
1 instances of rescue medication use
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Omalizumab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=5 participants at risk
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.
|
Omalizumab
n=5 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Delayed Injection Site Reaction
|
0.00%
0/5 • up to 9 months
|
20.0%
1/5 • Number of events 1 • up to 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place