Trial Outcomes & Findings for A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1) (NCT NCT00866788)
NCT ID: NCT00866788
Last Updated: 2017-07-11
Results Overview
The UAS is a composite diary-recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
25
|
21
|
|
Overall Study
COMPLETED
|
15
|
17
|
23
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
2
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
|
Overall Study
Disease progression
|
3
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=21 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age, Customized
12-<18 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Age, Customized
18-<40 years
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
11 participants
n=4 Participants
|
40 participants
n=21 Participants
|
|
Age, Customized
>=40 years
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
10 participants
n=4 Participants
|
45 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)Population: Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
The UAS is a composite diary-recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=20 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
|
-6.91 scores on a scale
Standard Deviation 9.84
|
-9.79 scores on a scale
Standard Deviation 11.75
|
-19.93 scores on a scale
Standard Deviation 12.38
|
-14.56 scores on a scale
Standard Deviation 10.17
|
SECONDARY outcome
Timeframe: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)Population: Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=20 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Change in the Weekly Pruritus Score From Baseline to Week 4
|
-3.45 scores on a scale
Standard Deviation 5.22
|
-4.50 scores on a scale
Standard Deviation 5.84
|
-9.22 scores on a scale
Standard Deviation 5.98
|
-6.46 scores on a scale
Standard Deviation 5.63
|
SECONDARY outcome
Timeframe: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)Population: Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=20 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Change in the Weekly Score for Number of Hives From Baseline to Week 4
|
-3.46 scores on a scale
Standard Deviation 5.17
|
-5.28 scores on a scale
Standard Deviation 6.91
|
-10.71 scores on a scale
Standard Deviation 6.75
|
-8.10 scores on a scale
Standard Deviation 6.00
|
SECONDARY outcome
Timeframe: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)Population: Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
The extent to which hives or itch interfered with participants' sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=20 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Change in the Weekly Score for Sleep Interference From Baseline to Week 4
|
-3.23 scores on a scale
Standard Deviation 5.93
|
-3.90 scores on a scale
Standard Deviation 5.03
|
-5.81 scores on a scale
Standard Deviation 5.36
|
-6.85 scores on a scale
Standard Deviation 6.23
|
SECONDARY outcome
Timeframe: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)Population: Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=20 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4
|
-1.38 Pills
Standard Deviation 4.39
|
-1.74 Pills
Standard Deviation 4.48
|
-2.64 Pills
Standard Deviation 5.17
|
-1.69 Pills
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: 16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")Population: Safety-Evaluable Population, which included all randomized patients who received any study drug. number (n) equals (=) number of participants analyzed in the specified category.
The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities. Additional AE data is provided in the AE section below. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE. A "Serious" AE is defined below.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=21 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Number of Patients With Adverse Events by Severity
4 Weeks - Any Adverse Event (n=21,23,25,21)
|
10 participants
|
8 participants
|
12 participants
|
10 participants
|
|
Number of Patients With Adverse Events by Severity
4 Weeks - Mild (n=21,23,25,21)
|
8 participants
|
4 participants
|
6 participants
|
7 participants
|
|
Number of Patients With Adverse Events by Severity
4 Weeks - Moderate (n=21,23,25,21)
|
2 participants
|
3 participants
|
5 participants
|
2 participants
|
|
Number of Patients With Adverse Events by Severity
4 Weeks - Severe (n=21,23,25,21)
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Patients With Adverse Events by Severity
Follow-up period-Any adverse event (n=20,18,23,20)
|
7 participants
|
9 participants
|
12 participants
|
5 participants
|
|
Number of Patients With Adverse Events by Severity
Follow-up period-Mild (n=20,18,23,20)
|
4 participants
|
5 participants
|
4 participants
|
3 participants
|
|
Number of Patients With Adverse Events by Severity
Follow-up period-Moderate (n=20,18,23,20)
|
2 participants
|
2 participants
|
6 participants
|
1 participants
|
|
Number of Patients With Adverse Events by Severity
Follow-up period-Severe (n=20,18,23,20)
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Safety-Evaluable Population
Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=21 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Number of Participants With Immunogenicity
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)Population: Pharmacokinetic-Evaluable Population included all randomized participants who received omalizumab and had pharmacokinetic data available. Here, number of participants analyzed = participants with available data for this outcome measure.
Cmax is the maximum (or peak) concentration of omalizumab in serum.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=20 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Omalizumab
|
11.4 micrograms per milliliter (µg/mL)
Standard Deviation 16.4
|
33.1 micrograms per milliliter (µg/mL)
Standard Deviation 10.4
|
67 micrograms per milliliter (µg/mL)
Standard Deviation 26.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)Population: Pharmacokinetic-Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.
Tmax is the time to maximum concentration of omalizumab.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=20 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Omalizumab
|
7.37 days
Standard Deviation 3.72
|
8.01 days
Standard Deviation 5.54
|
6.24 days
Standard Deviation 3.51
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)Population: Pharmacokinetic-Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.
AUCinf is the area under the concentration-time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg\*day/mL). Only participants having complete profiles and completed the study were included in the analysis.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=22 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=19 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)
|
317 µg*day/mL
Standard Deviation 99.6
|
1260 µg*day/mL
Standard Deviation 580
|
2800 µg*day/mL
Standard Deviation 1140
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)Population: Pharmacokinetic-Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.
Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=22 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=19 Participants
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of Omalizumab
|
18.2 days
Standard Deviation 4.76
|
17.1 days
Standard Deviation 4.41
|
22.5 days
Standard Deviation 5.9
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Omalizumab 75 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Omalizumab 300 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Omalizumab 600 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=21 participants at risk
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 participants at risk
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 participants at risk
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=21 participants at risk
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/23 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
4.0%
1/25 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
Other adverse events
| Measure |
Placebo
n=21 participants at risk
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 75 mg
n=23 participants at risk
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 300 mg
n=25 participants at risk
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
Omalizumab 600 mg
n=21 participants at risk
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
8.7%
2/23 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
12.0%
3/25 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
9.5%
2/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
17.4%
4/23 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
12.0%
3/25 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
4.8%
1/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/23 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
8.0%
2/25 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
14.3%
3/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
4.8%
1/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/23 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
8.0%
2/25 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
8.7%
2/23 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/25 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
|
Skin and subcutaneous tissue disorders
Idiopathic Uticaria
|
0.00%
0/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
4.3%
1/23 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
4.0%
1/25 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
9.5%
2/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.5%
2/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/23 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/25 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
0.00%
0/21 • Adverse Events were recorded from Day -7 until end of study at 16 weeks.
A Serious AE is any AE that is either: * Fatal * Life threatening * Requires or prolongs inpatient hospitalization * Results in persistent or significant disability/incapacity * A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment * Considered a significant medical event by the investigator
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights."
- Publication restrictions are in place
Restriction type: OTHER