Trial Outcomes & Findings for Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU) (NCT NCT03111628)
NCT ID: NCT03111628
Last Updated: 2021-06-14
Results Overview
The time (in days) to meaningful change in diary-based clinical symptoms as measured by the Urticaria Activity Score (UAS) from baseline (Wk -7 to Day -1) to the date at which an Minimally Important Difference (5 point change in weekly UAS 7) or achievement of \> 50% reduction in daily symptom score for 3 days if in the first week. The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. The UAS7 score obtained 1 week prior to randomization will be used as the baseline. The UAS is a validated measure of CIU disease activity calculated from the average of twice daily recorded itch (0 - 3; 0= no itch, 1= mild itch, 2= moderate itch, 3= severe itch) and hives (0 - 3, 0= no hives, 1= 1-6 hives, 2= 7-12 hives, 3= \> 12 hives in the past 12 hours) scores with a daily maximum of 6. The UAS-7 is the sum of 7 daily average UAS scores with a maximum value of 42 The UAS-7 is the sum of 7 daily average UAS scores with a maximum value of 42.
COMPLETED
PHASE4
18 participants
From first injection to time of meaningful change, up to 12 Weeks
2021-06-14
Participant Flow
Participant milestones
| Measure |
Omalizumab
Omalizumab 300mg every month for 3 doses
Omalizumab: omalizumab 300 mg every 4 weeks by subcutaneous injection
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Omalizumab
n=18 Participants
Omalizumab 300mg every month for 3 doses
Omalizumab: omalizumab 300 mg every 4 weeks by subcutaneous injection
|
|---|---|
|
Age, Continuous
|
44 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
|
Urticaria activity score (UAS) 7
|
29 units on a scale
n=18 Participants
|
PRIMARY outcome
Timeframe: From first injection to time of meaningful change, up to 12 WeeksThe time (in days) to meaningful change in diary-based clinical symptoms as measured by the Urticaria Activity Score (UAS) from baseline (Wk -7 to Day -1) to the date at which an Minimally Important Difference (5 point change in weekly UAS 7) or achievement of \> 50% reduction in daily symptom score for 3 days if in the first week. The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. The UAS7 score obtained 1 week prior to randomization will be used as the baseline. The UAS is a validated measure of CIU disease activity calculated from the average of twice daily recorded itch (0 - 3; 0= no itch, 1= mild itch, 2= moderate itch, 3= severe itch) and hives (0 - 3, 0= no hives, 1= 1-6 hives, 2= 7-12 hives, 3= \> 12 hives in the past 12 hours) scores with a daily maximum of 6. The UAS-7 is the sum of 7 daily average UAS scores with a maximum value of 42 The UAS-7 is the sum of 7 daily average UAS scores with a maximum value of 42.
Outcome measures
| Measure |
Basopenics
n=9 Participants
Subjects with blood basophils less than 8000/ml good
|
Non-basopenic
n=9 Participants
Subjects with \> 8000 basophils/ml
|
|---|---|---|
|
Time to 50% Decline in Clinical Symptoms Measured by the Urticaria Activity Score Seven Day(UAS7)
|
23 days
Standard Error 3
|
12 days
Standard Error 3
|
Adverse Events
Omalizumab
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