Chronic Idiopathic Urticaria
Conditions
Keywords
Xolair, CIU
Brief summary
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.
Interventions
DRUGomalizumab
Administered by subcutaneous injection
DRUGplacebo
Participants received a single subcutaneous placebo injection on Day 0 of the study.
DRUGH1 antihistamines
Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD
DRUGDiphenhydramine
Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* CIU diagnosis \> 3 months (by history) * No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)
Exclusion criteria
* Pregnant, breastfeeding, or women not taking contraception * Patients \< 40kg * Treatment with any investigational agent within 30 days of screening * Recent history of drug or alcohol abuse * Atopic dermatitis or other skin disease associated with pruritus * Clinically relevant major systemic disease (making interpretation of the study results difficult) * Previously treated with omalizumab (\< 12 months since last injection) * Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or plasmapheresis * Patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Weekly Score for Number of Hives From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | 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. |
| Change in the Weekly Score for Sleep Interference From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | 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. |
| Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | 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. |
| Number of Patients With Adverse Events by Severity | 16 weeks overall (data reported separately for up to 4 weeks and Weeks 5 to 16) | 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. |
| Change in the Weekly Pruritus Score From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | 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. |
| Maximum Observed Concentration (Cmax) of Omalizumab | 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) | Cmax is the maximum (or peak) concentration of omalizumab in serum. |
| Time to Maximum Concentration (Tmax) of Omalizumab | 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) | Tmax is the time to maximum concentration of omalizumab. |
| Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf) | 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) | 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. |
| Terminal Half-Life (t1/2) of Omalizumab | 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) | 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. |
| Number of Participants With Immunogenicity | 16 weeks | Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 23 |
| 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. | 25 |
| 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. | 21 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 1 |
| Overall Study | Disease progression | 3 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 1 |
| Overall Study | Pregnancy | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Omalizumab 75 mg | Omalizumab 300 mg | Omalizumab 600 mg | Total |
|---|---|---|---|---|---|
| Age, Customized 12-<18 years | 2 participants | 2 participants | 1 participants | 0 participants | 5 participants |
| Age, Customized 18-<40 years | 7 participants | 10 participants | 12 participants | 11 participants | 40 participants |
| Age, Customized >=40 years | 12 participants | 11 participants | 12 participants | 10 participants | 45 participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 17 Participants | 12 Participants | 61 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 8 Participants | 9 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 21 | 9 / 23 | 11 / 25 | 8 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 | 1 / 25 | 0 / 21 |
Outcome results
Primary
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | -6.91 scores on a scale | Standard Deviation 9.84 |
| Omalizumab 75 mg | Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | -9.79 scores on a scale | Standard Deviation 11.75 |
| Omalizumab 300 mg | Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | -19.93 scores on a scale | Standard Deviation 12.38 |
| Omalizumab 600 mg | Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | -14.56 scores on a scale | Standard Deviation 10.17 |
p-value: 0.1601van Elteren test
p-value: 0.0003van Elteren test
p-value: 0.0473van Elteren test
Secondary
Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf) | 317 µg*day/mL | Standard Deviation 99.6 |
| Omalizumab 75 mg | Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf) | 1260 µg*day/mL | Standard Deviation 580 |
| Omalizumab 300 mg | Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf) | 2800 µg*day/mL | Standard Deviation 1140 |
Secondary
Change in the Weekly Pruritus Score From Baseline to Week 4
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Weekly Pruritus Score From Baseline to Week 4 | -3.45 scores on a scale | Standard Deviation 5.22 |
| Omalizumab 75 mg | Change in the Weekly Pruritus Score From Baseline to Week 4 | -4.50 scores on a scale | Standard Deviation 5.84 |
| Omalizumab 300 mg | Change in the Weekly Pruritus Score From Baseline to Week 4 | -9.22 scores on a scale | Standard Deviation 5.98 |
| Omalizumab 600 mg | Change in the Weekly Pruritus Score From Baseline to Week 4 | -6.46 scores on a scale | Standard Deviation 5.63 |
p-value: 0.164van Elteren test
p-value: 0.0005van Elteren test
p-value: 0.0558van Elteren test
Secondary
Change in the Weekly Score for Number of Hives From Baseline to Week 4
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Weekly Score for Number of Hives From Baseline to Week 4 | -3.46 scores on a scale | Standard Deviation 5.17 |
| Omalizumab 75 mg | Change in the Weekly Score for Number of Hives From Baseline to Week 4 | -5.28 scores on a scale | Standard Deviation 6.91 |
| Omalizumab 300 mg | Change in the Weekly Score for Number of Hives From Baseline to Week 4 | -10.71 scores on a scale | Standard Deviation 6.75 |
| Omalizumab 600 mg | Change in the Weekly Score for Number of Hives From Baseline to Week 4 | -8.10 scores on a scale | Standard Deviation 6 |
p-value: 0.1411van Elteren test
p-value: 0.0003van Elteren test
p-value: 0.0248van Elteren test
Secondary
Change in the Weekly Score for Sleep Interference From Baseline to Week 4
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Weekly Score for Sleep Interference From Baseline to Week 4 | -3.23 scores on a scale | Standard Deviation 5.93 |
| Omalizumab 75 mg | Change in the Weekly Score for Sleep Interference From Baseline to Week 4 | -3.90 scores on a scale | Standard Deviation 5.03 |
| Omalizumab 300 mg | Change in the Weekly Score for Sleep Interference From Baseline to Week 4 | -5.81 scores on a scale | Standard Deviation 5.36 |
| Omalizumab 600 mg | Change in the Weekly Score for Sleep Interference From Baseline to Week 4 | -6.85 scores on a scale | Standard Deviation 6.23 |
p-value: 0.5507van Elteren test
p-value: 0.1525van Elteren test
p-value: 0.0449van Elteren test
Secondary
Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4 | -1.38 Pills | Standard Deviation 4.39 |
| Omalizumab 75 mg | Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4 | -1.74 Pills | Standard Deviation 4.48 |
| Omalizumab 300 mg | Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4 | -2.64 Pills | Standard Deviation 5.17 |
| Omalizumab 600 mg | Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4 | -1.69 Pills | Standard Deviation 3.56 |
p-value: 0.7261van Elteren test
p-value: 0.162van Elteren test
p-value: 0.6504van Elteren test
Secondary
Maximum Observed Concentration (Cmax) of Omalizumab
Cmax is the maximum (or peak) concentration of omalizumab in serum.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Concentration (Cmax) of Omalizumab | 11.4 micrograms per milliliter (µg/mL) | Standard Deviation 16.4 |
| Omalizumab 75 mg | Maximum Observed Concentration (Cmax) of Omalizumab | 33.1 micrograms per milliliter (µg/mL) | Standard Deviation 10.4 |
| Omalizumab 300 mg | Maximum Observed Concentration (Cmax) of Omalizumab | 67 micrograms per milliliter (µg/mL) | Standard Deviation 26.9 |
Secondary
Number of Participants With Immunogenicity
Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).
Time frame: 16 weeks
Population: Safety-Evaluable Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Immunogenicity | 0 participants |
| Omalizumab 75 mg | Number of Participants With Immunogenicity | 0 participants |
| Omalizumab 300 mg | Number of Participants With Immunogenicity | 0 participants |
| Omalizumab 600 mg | Number of Participants With Immunogenicity | 0 participants |
Secondary
Number of Patients With Adverse Events by Severity
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Adverse Events by Severity | 4 Weeks - Any Adverse Event (n=21,23,25,21) | 10 participants |
| Placebo | Number of Patients With Adverse Events by Severity | 4 Weeks - Mild (n=21,23,25,21) | 8 participants |
| Placebo | Number of Patients With Adverse Events by Severity | 4 Weeks - Moderate (n=21,23,25,21) | 2 participants |
| Placebo | Number of Patients With Adverse Events by Severity | 4 Weeks - Severe (n=21,23,25,21) | 0 participants |
| Placebo | Number of Patients With Adverse Events by Severity | Follow-up period-Any adverse event (n=20,18,23,20) | 7 participants |
| Placebo | Number of Patients With Adverse Events by Severity | Follow-up period-Mild (n=20,18,23,20) | 4 participants |
| Placebo | Number of Patients With Adverse Events by Severity | Follow-up period-Moderate (n=20,18,23,20) | 2 participants |
| Placebo | Number of Patients With Adverse Events by Severity | Follow-up period-Severe (n=20,18,23,20) | 1 participants |
| Omalizumab 75 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Mild (n=20,18,23,20) | 5 participants |
| Omalizumab 75 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Any adverse event (n=20,18,23,20) | 9 participants |
| Omalizumab 75 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Mild (n=21,23,25,21) | 4 participants |
| Omalizumab 75 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Severe (n=20,18,23,20) | 2 participants |
| Omalizumab 75 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Moderate (n=20,18,23,20) | 2 participants |
| Omalizumab 75 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Severe (n=21,23,25,21) | 1 participants |
| Omalizumab 75 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Moderate (n=21,23,25,21) | 3 participants |
| Omalizumab 75 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Any Adverse Event (n=21,23,25,21) | 8 participants |
| Omalizumab 300 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Moderate (n=20,18,23,20) | 6 participants |
| Omalizumab 300 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Moderate (n=21,23,25,21) | 5 participants |
| Omalizumab 300 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Severe (n=21,23,25,21) | 1 participants |
| Omalizumab 300 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Any adverse event (n=20,18,23,20) | 12 participants |
| Omalizumab 300 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Mild (n=20,18,23,20) | 4 participants |
| Omalizumab 300 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Severe (n=20,18,23,20) | 2 participants |
| Omalizumab 300 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Any Adverse Event (n=21,23,25,21) | 12 participants |
| Omalizumab 300 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Mild (n=21,23,25,21) | 6 participants |
| Omalizumab 600 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Moderate (n=21,23,25,21) | 2 participants |
| Omalizumab 600 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Severe (n=21,23,25,21) | 1 participants |
| Omalizumab 600 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Mild (n=21,23,25,21) | 7 participants |
| Omalizumab 600 mg | Number of Patients With Adverse Events by Severity | 4 Weeks - Any Adverse Event (n=21,23,25,21) | 10 participants |
| Omalizumab 600 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Any adverse event (n=20,18,23,20) | 5 participants |
| Omalizumab 600 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Severe (n=20,18,23,20) | 1 participants |
| Omalizumab 600 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Moderate (n=20,18,23,20) | 1 participants |
| Omalizumab 600 mg | Number of Patients With Adverse Events by Severity | Follow-up period-Mild (n=20,18,23,20) | 3 participants |
Secondary
Terminal Half-Life (t1/2) of Omalizumab
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Terminal Half-Life (t1/2) of Omalizumab | 18.2 days | Standard Deviation 4.76 |
| Omalizumab 75 mg | Terminal Half-Life (t1/2) of Omalizumab | 17.1 days | Standard Deviation 4.41 |
| Omalizumab 300 mg | Terminal Half-Life (t1/2) of Omalizumab | 22.5 days | Standard Deviation 5.9 |
Secondary
Time to Maximum Concentration (Tmax) of Omalizumab
Tmax is the time to maximum concentration of omalizumab.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Maximum Concentration (Tmax) of Omalizumab | 7.37 days | Standard Deviation 3.72 |
| Omalizumab 75 mg | Time to Maximum Concentration (Tmax) of Omalizumab | 8.01 days | Standard Deviation 5.54 |
| Omalizumab 300 mg | Time to Maximum Concentration (Tmax) of Omalizumab | 6.24 days | Standard Deviation 3.51 |