Trial Outcomes & Findings for Cold Urticaria Treatment With Xolair (NCT NCT01580592)
NCT ID: NCT01580592
Last Updated: 2017-04-07
Results Overview
The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
day 70
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Omalizumab 150mg
Omalizumab: 150mg, s.c., every 4 weeks
|
Omalizumab 300mg
Omalizumab: 300mg, s.c., every 4 weeks
|
Placebo
Placebo: Placebo, s.c., every 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
12
|
|
Overall Study
COMPLETED
|
10
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cold Urticaria Treatment With Xolair
Baseline characteristics by cohort
| Measure |
Omalizumab 150mg
n=10 Participants
Omalizumab: 150mg, s.c., every 4 weeks
|
Omalizumab 300mg
n=9 Participants
Omalizumab: 300mg, s.c., every 4 weeks
|
Placebo
n=12 Participants
Placebo: Placebo, s.c., every 4 weeks
|
Total
n=31 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: day 70Population: female and male
The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.
Outcome measures
| Measure |
Omalizumab 150mg
n=10 Participants
Omalizumab: 150mg, s.c., every 4 weeks
|
Omalizumab 300mg
n=9 Participants
Omalizumab: 300mg, s.c., every 4 weeks
|
Placebo
n=12 Participants
Placebo: Placebo, s.c., every 4 weeks
|
|---|---|---|---|
|
Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo
|
-10.6 degree celcius
Standard Deviation 7.6
|
-10.4 degree celcius
Standard Deviation 9.4
|
-0.3 degree celcius
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: day 70This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting
Outcome measures
| Measure |
Omalizumab 150mg
n=10 Participants
Omalizumab: 150mg, s.c., every 4 weeks
|
Omalizumab 300mg
n=9 Participants
Omalizumab: 300mg, s.c., every 4 weeks
|
Placebo
n=12 Participants
Placebo: Placebo, s.c., every 4 weeks
|
|---|---|---|---|
|
Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events
|
7 participants
|
7 participants
|
9 participants
|
Adverse Events
Omalizumab 150mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Omalizumab 300mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omalizumab 150mg
n=10 participants at risk
Omalizumab: 150mg, s.c., every 4 weeks
|
Omalizumab 300mg
n=9 participants at risk
Omalizumab: 300mg, s.c., every 4 weeks
|
Placebo
n=12 participants at risk
Placebo: Placebo, s.c., every 4 weeks
|
|---|---|---|---|
|
General disorders
Headache
|
20.0%
2/10
|
22.2%
2/9
|
33.3%
4/12
|
|
Infections and infestations
upper respiratory tract infection
|
20.0%
2/10
|
22.2%
2/9
|
33.3%
4/12
|
Additional Information
Professor Dr. Martin Metz
Charité - University of Berlin; Dpt. of Dermatology and Allergy
Phone: +49 30 450 518 159
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place