Trial Outcomes & Findings for Sputum-derived Cellular Targets After Xolair (Omalizumab) (NCT NCT02658877)
NCT ID: NCT02658877
Last Updated: 2019-09-30
Results Overview
TERMINATED
PHASE4
3 participants
16 Weeks of Treatment of omalizumab or placebo
2019-09-30
Participant Flow
Participant milestones
| Measure |
Omalizumab
Omalizumab: Omalizumab will be dosed according to dosing and U.S. administration guidelines for omalizumab. Omalizumab will be dosed every 2-4 weeks based on the patient's pre treatment serum IgE level (IU/mL) and initial visit body weight (kg). Omalizumab will be delivered as a subcutaneous injection. Standard safety precautions for dosing will be observed, including clinical observation after dosing, and provision of an epinephrine pen. Maintenance asthma treatment will remain unchanged.
|
Placebo
Placebo: Saline with a volume of injection frequency indicated based on the patient's serum IgE and body weight, delivered subcutaneously and supplied by Novartis Pharma.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sputum-derived Cellular Targets After Xolair (Omalizumab)
Baseline characteristics by cohort
| Measure |
Omalizumab
n=3 Participants
Omalizumab: Omalizumab will be dosed according to dosing and U.S. administration guidelines for omalizumab. Omalizumab will be dosed every 2-4 weeks based on the patient's pre treatment serum IgE level (IU/mL) and initial visit body weight (kg). Omalizumab will be delivered as a subcutaneous injection. Standard safety precautions for dosing will be observed, including clinical observation after dosing, and provision of an epinephrine pen. Maintenance asthma treatment will remain unchanged.
|
Placebo
Placebo: Saline with a volume of injection frequency indicated based on the patient's serum IgE and body weight, delivered subcutaneously and supplied by Novartis Pharma.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: Most (n=124) of these patients failed screening criteria and investigator did not move forward
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 Weeks of Treatment of omalizumab or placeboPopulation: No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Omalizumab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place