- ICH GCP
- EU klinikai vizsgálatok nyilvántartása
Klinikai vizsgálatok Nct
Clinical Trial Results:
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, RESPONSE DURATION AND SAFETY OF XOLAIR (OMALIZUMAB) IN PATIENTS WITH CHRONIC IDIOPATHIC URTICARIA (CIU) WHO REMAIN SYMPTOMATIC DESPITE ANTIHISTAMINE TREATMENT (H1)
Summary | |
EudraCT number | 2010-022785-27 |
Trial protocol | FR DE DK IT ES |
Global end of trial date | 27 Jun 2012 |
Results information | |
Results version number | v1(current) |
This version publication date | 08 Apr 2016 |
First version publication date | 08 Apr 2016 |
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification | |||
Sponsor protocol code | Q4882g | ||
Additional study identifiers | |||
ISRCTN number | - | ||
US NCT number | NCT01292473 | ||
WHO universal trial number (UTN) | - | ||
Sponsors | |||
Sponsor organisation name | Genentech, Inc. | ||
Sponsor organisation address | Grenzacherstrasse 124, Basel, Switzerland, CH-4070 | ||
Public contact | Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com | ||
Scientific contact | Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com | ||
Paediatric regulatory details | |||
Is trial part of an agreed paediatric investigation plan (PIP) | No | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? | No | ||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? | No | ||
Results analysis stage | |||
Analysis stage | Final | ||
Date of interim/final analysis | 29 Aug 2012 | ||
Is this the analysis of the primary completion data? | Yes | ||
Primary completion date | 27 Jun 2012 | ||
Global end of trial reached? | Yes | ||
Global end of trial date | 27 Jun 2012 | ||
Was the trial ended prematurely? | No | ||
General information about the trial | |||
Main objective of the trial | To evaluate the efficacy of omalizumab compared with placebo in participants with refractory chronic idiopathic urticaria (CIU) receiving concomitant H1 antihistamine therapy | ||
Protection of trial subjects | This study was conducted in accordance with the United States (U.S.) Food and Drug Administration (FDA) regulations, ICH E6 Guideline for Good Clinical Practice (GCP), Declaration of Helsinki, and applicable local, state, and federal laws, as well as other applicable country laws. For example, the U.S. sites, investigators were trained in GCP according to Genentech and Quintiles standard operating procedures and a written commitment from investigators to comply with GCP was obtained. Approval from the independent ethics committee/institutional review board was obtained before study start-up and prior to implementation of any protocol amendments. The approval from the relevant competent authority prior to starting the study was also obtained. An Independent data monitoring committee was established to monitor safety and study conduct; the members of whom were external to the Sponsor and met at regular intervals (at least once every 6 months) until the end of the trial. A separate anaphylaxis review committee comprised of external experts in CIU and anaphylaxis was convened to clinically review anaphylaxis cases in a blinded fashion. | ||
Background therapy | All participants received standard-of-care H1 antihistamine treatment at approved doses during the screening, treatment, and follow-up periods. Diphenhydramine (25 mg) treatment was provided on an as-needed basis (up to a maximum of three doses in 24 hours, based on local regulations) during the screening, treatment, and follow-up periods. The medications approved for use in the countries outside the U. S. where the study was conducted were cetirizine 5 or 10 mg once per day (QD), levocetirizine dihydrochloride 2.5 or 5 mg QD, fexofenadine 60 mg twice per day or 180 mg QD, loratadine 10 mg QD, and desloratadine 5 mg QD. Medications for diseases other than CIU (asthma or gastroesophageal reflux disease) were permitted during the study. | ||
Evidence for comparator | - | ||
Actual start date of recruitment | 10 Mar 2011 | ||
Long term follow-up planned | Yes | ||
Long term follow-up rationale | Safety | ||
Long term follow-up duration | 6 Months | ||
Independent data monitoring committee (IDMC) involvement? | Yes | ||
Population of trial subjects | |||
Number of subjects enrolled per country | |||
Country: Number of subjects enrolled | United States: 234 | ||
Country: Number of subjects enrolled | Turkey: 5 | ||
Country: Number of subjects enrolled | Poland: 18 | ||
Country: Number of subjects enrolled | Spain: 10 | ||
Country: Number of subjects enrolled | Denmark: 4 | ||
Country: Number of subjects enrolled | France: 3 | ||
Country: Number of subjects enrolled | Germany: 44 | ||
Country: Number of subjects enrolled | Italy: 4 | ||
Worldwide total number of subjects | 322 | ||
EEA total number of subjects | 83 | ||
Number of subjects enrolled per age group | |||
In utero | 0 | ||
Preterm newborn - gestational age | 0 | ||
Newborns (0-27 days) | 0 | ||
Infants and toddlers (28 days-23 months) | 0 | ||
Children (2-11 years) | 0 | ||
Adolescents (12-17 years) | 10 | ||
Adults (18-64 years) | 294 | ||
From 65 to 84 years | 18 | ||
85 years and over | 0 |
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Recruitment | ||||||||||||||||||||||||||||||||||||||||||||||
Recruitment details | The study was conducted in six European countries along with Turkey and the U.S. from 11 Mar 2011 to 27 Jun 2012. A total of 466 participants were enrolled. | |||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment | ||||||||||||||||||||||||||||||||||||||||||||||
Screening details | Out of 466 participants, 322 were randomized (79 in the Placebo group, 82 in the Omalizumab 75 mg group, 82 in the Omalizumab 150 mg group, and 79 in the Omalizumab 300 mg group). The most frequent reasons for screen failures were evidence of current drug or alcohol abuse, contraindications to diphenhydramine, and other. | |||||||||||||||||||||||||||||||||||||||||||||
Period 1 | ||||||||||||||||||||||||||||||||||||||||||||||
Period 1 title | Overall trial (overall period) | |||||||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? | Yes | |||||||||||||||||||||||||||||||||||||||||||||
Allocation method | Randomised - controlled | |||||||||||||||||||||||||||||||||||||||||||||
Blinding used | Double blind | |||||||||||||||||||||||||||||||||||||||||||||
Roles blinded | Subject, Investigator, Carer, Assessor | |||||||||||||||||||||||||||||||||||||||||||||
Blinding implementation details | Study drug supplies were shipped blinded to each site. An individual not involved with evaluating the participant was identified to administer the study drug. There were no treatment assignment unblindings during the study. | |||||||||||||||||||||||||||||||||||||||||||||
Arms | ||||||||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive | Yes | |||||||||||||||||||||||||||||||||||||||||||||
Arm title | Placebo | |||||||||||||||||||||||||||||||||||||||||||||
Arm description | Participants received only placebo injections (i.e., no active treatment) | |||||||||||||||||||||||||||||||||||||||||||||
Arm type | Placebo | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name | Placebo | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code | ||||||||||||||||||||||||||||||||||||||||||||||
Other name | ||||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms | Powder for injection | |||||||||||||||||||||||||||||||||||||||||||||
Routes of administration | Subcutaneous use | |||||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details | Participants received the placebo subcutaneously every 4 weeks on Day 1, Week 4, and Week 8 upon reconstitution with 1.4 mL sterile water for injection (SWFI). Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site. Each placebo vial contained 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial was designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP. | |||||||||||||||||||||||||||||||||||||||||||||
Arm title | Omalizumab 75 mg | |||||||||||||||||||||||||||||||||||||||||||||
Arm description | Participants received at least one 75 mg omalizumab injection but no higher active dose level (150 mg or 300 mg) injections during the treatment period. Six participants were randomized to the Omalizumab 75 mg group received at least one dose of omalizumab 150 mg during the treatment period and were therefore included in the Omalizumab 150 mg group. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type | Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name | Omalizumab | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code | RO5489789 | |||||||||||||||||||||||||||||||||||||||||||||
Other name | Xolair | |||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms | Powder for injection | |||||||||||||||||||||||||||||||||||||||||||||
Routes of administration | Subcutaneous use | |||||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details | Participants received 75 mg omalizumab subcutaneously on Day 1, Week 4, and Week 8, reconstituted with 1.4 mL SWFI. Each omalizumab vial contained 202.5 mg omalizumab, 145.5 mg sucrose, 2.8 mg, L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial was designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP. | |||||||||||||||||||||||||||||||||||||||||||||
Arm title | Omalizumab 150 mg | |||||||||||||||||||||||||||||||||||||||||||||
Arm description | Participants who received at least one 150 mg omalizumab injection but no higher active dose level (300 mg) injections during the treatment period. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type | Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name | Omalizumab | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code | RO5489789 | |||||||||||||||||||||||||||||||||||||||||||||
Other name | Xolair | |||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms | Powder for injection | |||||||||||||||||||||||||||||||||||||||||||||
Routes of administration | Subcutaneous use | |||||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details | Participants received 150 mg omalizumab subcutaneously on Day 1, Week 4, and Week 8, reconstituted with 1.4 mL SWFI. Each omalizumab vial contained 202.5 mg omalizumab, 145.5 mg sucrose, 2.8 mg, L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial was designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP. | |||||||||||||||||||||||||||||||||||||||||||||
Arm title | Omalizumab 300 mg | |||||||||||||||||||||||||||||||||||||||||||||
Arm description | Participants received at least one 300 mg omalizumab injection during the treatment period. Two participants were randomized to the Omalizumab 300 mg group; however, they received one dose of omalizumab 150 mg during the treatment period. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type | Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name | Omalizumab | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code | RO5489789 | |||||||||||||||||||||||||||||||||||||||||||||
Other name | Xolair | |||||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms | Powder for injection | |||||||||||||||||||||||||||||||||||||||||||||
Routes of administration | Subcutaneous use | |||||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details | Participants received 300 mg omalizumab subcutaneously on Day 1, Week 4, and Week 8, with 1.4 mL SWFI. Each omalizumab vial contained 202.5 mg omalizumab, 145.5 mg sucrose, 2.8 mg, L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20. Each vial was designed to deliver 150 mg of omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP. | |||||||||||||||||||||||||||||||||||||||||||||
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Baseline characteristics reporting groups | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | Participants received only placebo injections (i.e., no active treatment) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Omalizumab 75 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | Participants received at least one 75 mg omalizumab injection but no higher active dose level (150 mg or 300 mg) injections during the treatment period. Six participants were randomized to the Omalizumab 75 mg group received at least one dose of omalizumab 150 mg during the treatment period and were therefore included in the Omalizumab 150 mg group. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Omalizumab 150 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | Participants who received at least one 150 mg omalizumab injection but no higher active dose level (300 mg) injections during the treatment period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Omalizumab 300 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | Participants received at least one 300 mg omalizumab injection during the treatment period. Two participants were randomized to the Omalizumab 300 mg group; however, they received one dose of omalizumab 150 mg during the treatment period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups | |||
Reporting group title | Placebo | ||
Reporting group description | Participants received only placebo injections (i.e., no active treatment) | ||
Reporting group title | Omalizumab 75 mg | ||
Reporting group description | Participants received at least one 75 mg omalizumab injection but no higher active dose level (150 mg or 300 mg) injections during the treatment period. Six participants were randomized to the Omalizumab 75 mg group received at least one dose of omalizumab 150 mg during the treatment period and were therefore included in the Omalizumab 150 mg group. | ||
Reporting group title | Omalizumab 150 mg | ||
Reporting group description | Participants who received at least one 150 mg omalizumab injection but no higher active dose level (300 mg) injections during the treatment period. | ||
Reporting group title | Omalizumab 300 mg | ||
Reporting group description | Participants received at least one 300 mg omalizumab injection during the treatment period. Two participants were randomized to the Omalizumab 300 mg group; however, they received one dose of omalizumab 150 mg during the treatment period. | ||
Subject analysis set title | Safety population | ||
Subject analysis set type | Safety analysis | ||
Subject analysis set description | This population included participants who received at least one dose of either placebo or the study drug (omalizumab 75 mg/150 mg/ 300 mg according to the actual treatment received). | ||
Subject analysis set title | Modified intent to treat population | ||
Subject analysis set type | Intention-to-treat | ||
Subject analysis set description | Modified intent to treat (mITT) population included all participants randomized in the study who received at least one dose of study drug. | ||
Subject analysis set title | Pharmacokinetic population | ||
Subject analysis set type | Sub-group analysis | ||
Subject analysis set description | Pharmacokinetic (PK-evaluable) population included all randomized participants who received at least one dose of the study drug and had provided at least one serum sample for determination of omalizumab concentration. |
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End point title | Mean change in weekly itch severity score from Baseline at Week 12 | ||||||||||||||||||||
End point description | Weekly itch severity score is a component of the urticaria activity score over 7 days (UAS7). Daily itch severity score is the average of the morning and evening scores with use of a scale of 0 (none) to 3 (severe). Weekly itch severity score is the sum of the daily scores over 7 days; thus, the weekly score represents pruritus (itch) severity on a scale from 0 (minimum) to 21 (maximum). Negative value indicated decrease in mean weekly itch severity score from the baseline in all treatment groups during the 28-week study period. Change from Baseline was defined as itch severity score at Week 12 minus the baseline score and was calculated using baseline observation carried forward (BOCF) method. This analysis was performed on mITT population. | ||||||||||||||||||||
End point type | Primary | ||||||||||||||||||||
End point timeframe | Baseline (Screening [Days -18 to -7]) and Week 12 | ||||||||||||||||||||
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Statistical analysis title | Change from Baseline in weekly itch severity score | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | superiority | ||||||||||||||||||||
P-value | = 0.4637 [1] | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -0.69 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -2.54 | ||||||||||||||||||||
upper limit | 1.16 | ||||||||||||||||||||
Notes [1] - ANCOVA t-test was used to derive the 'p-value'. | |||||||||||||||||||||
Statistical analysis title | Change from Baseline in weekly itch severity score | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | superiority | ||||||||||||||||||||
P-value | = 0.0011 [2] | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -3.04 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -4.85 | ||||||||||||||||||||
upper limit | -1.24 | ||||||||||||||||||||
Notes [2] - ANCOVA t-test was used to derive the 'p-value'. | |||||||||||||||||||||
Statistical analysis title | Change from Baseline in weekly itch severity score | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | ||||||||||||||||||||
Number of subjects included in analysis | 158 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | superiority | ||||||||||||||||||||
P-value | < 0.0001 [3] | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -4.81 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -6.49 | ||||||||||||||||||||
upper limit | -3.13 | ||||||||||||||||||||
Notes [3] - ANCOVA t-test was used to derive the 'p-value'. |
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End point title | Mean change from Baseline in urticaria activity score over 7 days at Week 12 | ||||||||||||||||||||
End point description | The UAS7 is a composite of recorded score with numeric severity intensity ratings for the number of wheals (hives); and the intensity of the itch, measured twice daily (morning and evening). It was measured on a scale of 0 (none ) to 3 (intense/severe) . Daily UAS is the average of morning and evening scores (range, 0−6 points/day) and the UAS7 is the sum of the daily UAS scores over 7 days (range, 0−42). Negative value indicated decrease in mean UAS from the baseline in all treatment groups during the 28-week study period. Change from Baseline was defined as urticaria activity score over 7 days at Week 12 minus the baseline score and was calculated using BOCF method. This analysis was performed on mITT population. | ||||||||||||||||||||
End point type | Secondary | ||||||||||||||||||||
End point timeframe | Baseline (Screening [Days -18 to -7]) and Week 12 | ||||||||||||||||||||
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Statistical analysis title | Change from Baseline in UAS7 at Week 12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.1575 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -2.73 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -6.53 | ||||||||||||||||||||
upper limit | 1.07 | ||||||||||||||||||||
Statistical analysis title | Change from Baseline in UAS7 at Week 12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.0001 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -7.69 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -11.49 | ||||||||||||||||||||
upper limit | -3.88 | ||||||||||||||||||||
Statistical analysis title | Change from Baseline in UAS 7 at Week 12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | ||||||||||||||||||||
Number of subjects included in analysis | 158 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | < 0.0001 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -12.4 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -16.13 | ||||||||||||||||||||
upper limit | -8.66 |
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End point title | Mean change from Baseline in weekly number of hives score at Week 12 | ||||||||||||||||||||
End point description | Number of hives is measured twice daily (morning and evening), on a scale from 0 (none) to 3 (> 12 hives per 12 hours). Daily hives score is the average of morning and evening scores, and the weekly hives score is the sum of the daily hives scores over 7 days (range, 0−21). Change from Baseline was defined as itch severity score at Week 12 minus the baseline score and was calculated using BOCF method. This analysis was performed on mITT population. | ||||||||||||||||||||
End point type | Secondary | ||||||||||||||||||||
End point timeframe | Baseline (Screening [Days -18 to -7]) and Week 12 | ||||||||||||||||||||
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Statistical analysis title | Change from Baseline in weekly number of hives | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.0603 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -2.01 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -4.11 | ||||||||||||||||||||
upper limit | 0.09 | ||||||||||||||||||||
Statistical analysis title | Change from Baseline in weekly number of hives | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | < 0.0001 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -4.51 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -6.65 | ||||||||||||||||||||
upper limit | -2.36 | ||||||||||||||||||||
Statistical analysis title | Change from Baseline in weekly number of hives | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | ||||||||||||||||||||
Number of subjects included in analysis | 158 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | < 0.0001 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -7.09 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -9.26 | ||||||||||||||||||||
upper limit | -4.93 |
| |||||||||||||||||||||
End point title | Median time to minimally important difference response in the weekly itch severity score by Week 12 | ||||||||||||||||||||
End point description | The minimally important difference (MID) response for weekly itch severity score was defined as a reduction from Baseline in weekly itch severity score of >= 5 points. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved. This analysis was performed on mITT population. | ||||||||||||||||||||
End point type | Secondary | ||||||||||||||||||||
End point timeframe | Up to Week 12 | ||||||||||||||||||||
| |||||||||||||||||||||
Statistical analysis title | Time to MID response in weekly itch severity score | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.0478 | ||||||||||||||||||||
Method | Cochran-Mantel-Haenszel | ||||||||||||||||||||
Parameter type | Hazard ratio (HR) | ||||||||||||||||||||
Point estimate | 1.43 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | 1 | ||||||||||||||||||||
upper limit | 2.05 | ||||||||||||||||||||
Statistical analysis title | Time to MID response in weekly itch severity score | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.0101 | ||||||||||||||||||||
Method | Cochran-Mantel-Haenszel | ||||||||||||||||||||
Parameter type | Hazard ratio (HR) | ||||||||||||||||||||
Point estimate | 1.59 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | 1.12 | ||||||||||||||||||||
upper limit | 2.26 | ||||||||||||||||||||
Statistical analysis title | Time to MID response in weekly itch severity score | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | ||||||||||||||||||||
Number of subjects included in analysis | 158 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | < 0.0001 | ||||||||||||||||||||
Method | Cochran-Mantel-Haenszel | ||||||||||||||||||||
Parameter type | Hazard ratio (HR) | ||||||||||||||||||||
Point estimate | 2.12 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | 1.48 | ||||||||||||||||||||
upper limit | 3.03 |
| ||||||||||||||||
End point title | Number of participants with urticaria activity score 7 less than or equal to 6 at Week 12 | |||||||||||||||
End point description | The UAS7 less than or equal to (<=) 6 identifies participants whose conditions are considered clinically well controlled. The UAS is a composite of recorded scores with numeric severity intensity ratings on a scale of 0 (none) to 3 (intense/severe) for analysis of the number of wheals (hives) and the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (range, 0−6 points per day) and the UAS7 is the sum of the daily UAS scores over 7 days (range, 0−42). Baseline UAS7 was calculated using data from the 7 days prior to the first treatment date. A higher UAS indicated more urticaria activity. A negative change score indicated improvement. This analysis was performed on mITT population. | |||||||||||||||
End point type | Secondary | |||||||||||||||
End point timeframe | Week 12 | |||||||||||||||
| ||||||||||||||||
Statistical analysis title | Participants with UAS7 | |||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | |||||||||||||||
Number of subjects included in analysis | 161 | |||||||||||||||
Analysis specification | Pre-specified | |||||||||||||||
Analysis type | other | |||||||||||||||
P-value | = 0.3419 | |||||||||||||||
Method | Cochran-Mantel-Haenszel | |||||||||||||||
Confidence interval | ||||||||||||||||
Statistical analysis title | Participants with UAS7 | |||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | |||||||||||||||
Number of subjects included in analysis | 161 | |||||||||||||||
Analysis specification | Pre-specified | |||||||||||||||
Analysis type | other | |||||||||||||||
P-value | = 0.001 | |||||||||||||||
Method | Cochran-Mantel-Haenszel | |||||||||||||||
Confidence interval | ||||||||||||||||
Statistical analysis title | participants with UAS7 | |||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | |||||||||||||||
Number of subjects included in analysis | 158 | |||||||||||||||
Analysis specification | Pre-specified | |||||||||||||||
Analysis type | other | |||||||||||||||
P-value | < 0.0001 | |||||||||||||||
Method | Cochran-Mantel-Haenszel | |||||||||||||||
Confidence interval |
| ||||||||||||||||
End point title | Number of participants with minimally important difference in weekly itch severity score at Week 12 | |||||||||||||||
End point description | The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement. The MID response for weekly itch severity score was defined as a reduction from Baseline in weekly itch severity score of 5 points or more. This outcome measure shows number of participants classified as MID responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than that at the Baseline. This analysis was performed on mITT population. | |||||||||||||||
End point type | Secondary | |||||||||||||||
End point timeframe | Week 12 | |||||||||||||||
| ||||||||||||||||
Statistical analysis title | Participants with weekly itch score MID response | |||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | |||||||||||||||
Number of subjects included in analysis | 161 | |||||||||||||||
Analysis specification | Pre-specified | |||||||||||||||
Analysis type | other | |||||||||||||||
P-value | = 0.4366 | |||||||||||||||
Method | Cochran-Mantel-Haenszel | |||||||||||||||
Confidence interval | ||||||||||||||||
Statistical analysis title | Participants with weekly itch score MID Response | |||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | |||||||||||||||
Number of subjects included in analysis | 161 | |||||||||||||||
Analysis specification | Pre-specified | |||||||||||||||
Analysis type | other | |||||||||||||||
P-value | = 0.0045 | |||||||||||||||
Method | Cochran-Mantel-Haenszel | |||||||||||||||
Confidence interval | ||||||||||||||||
Statistical analysis title | Participants with weekly itch score MID response | |||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | |||||||||||||||
Number of subjects included in analysis | 158 | |||||||||||||||
Analysis specification | Pre-specified | |||||||||||||||
Analysis type | other | |||||||||||||||
P-value | < 0.0001 | |||||||||||||||
Method | Cochran-Mantel-Haenszel | |||||||||||||||
Confidence interval |
| |||||||||||||||||||||
End point title | Mean change from Baseline in the weekly size of the largest hive score at Week 12 | ||||||||||||||||||||
End point description | The size of the largest hive is assessed twice daily (morning and evening) on a scale of largest hive score (LHC) as 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores over the 7 days prior to the first treatment and was calculated using BOCF method. A higher score indicates larger hives. A negative change score indicates a reduction in hive size. This analysis was performed on mITT population. | ||||||||||||||||||||
End point type | Secondary | ||||||||||||||||||||
End point timeframe | Baseline (Screening [Days -18 to -7]) and Week 12 | ||||||||||||||||||||
| |||||||||||||||||||||
Statistical analysis title | Change from Baseline in the weekly size of the LHC | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.0082 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -2.48 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -4.32 | ||||||||||||||||||||
upper limit | -0.65 | ||||||||||||||||||||
Statistical analysis title | Change from Baseline in the weekly size of the LHC | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | < 0.0001 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -3.76 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -5.61 | ||||||||||||||||||||
upper limit | -1.9 | ||||||||||||||||||||
Statistical analysis title | Change from Baseline in the weekly size of the LHC | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | ||||||||||||||||||||
Number of subjects included in analysis | 158 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | < 0.0001 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -7.15 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -9.03 | ||||||||||||||||||||
upper limit | -5.27 |
| |||||||||||||||||||||
End point title | Mean change from Baseline in the overall dermatology life quality index at Week 12 | ||||||||||||||||||||
End point description | Dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (not at all) to 3 (high). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement. This analysis was performed on mITT population. | ||||||||||||||||||||
End point type | Secondary | ||||||||||||||||||||
End point timeframe | Baseline (Screening [Days -18 to -7]) and Week 12 | ||||||||||||||||||||
| |||||||||||||||||||||
Statistical analysis title | Change From Baseline in DLQI at Week 12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.1207 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -1.68 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -3.82 | ||||||||||||||||||||
upper limit | 0.45 | ||||||||||||||||||||
Statistical analysis title | Change From Baseline in DLQI at Week 12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | ||||||||||||||||||||
Number of subjects included in analysis | 161 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.0215 [4] | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -2.51 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -4.64 | ||||||||||||||||||||
upper limit | -0.38 | ||||||||||||||||||||
Notes [4] - p-value is derived from ANCOVA t-test. | |||||||||||||||||||||
Statistical analysis title | Change From Baseline in DLQI at Week 12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | ||||||||||||||||||||
Number of subjects included in analysis | 158 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.0004 | ||||||||||||||||||||
Method | ANCOVA | ||||||||||||||||||||
Parameter type | Mean difference (final values) | ||||||||||||||||||||
Point estimate | -3.79 | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | -5.85 | ||||||||||||||||||||
upper limit | -1.73 |
| |||||||||||||||||||||
End point title | Mean percentage of angioedema-free days from Week 4 to Week 12 | ||||||||||||||||||||
End point description | The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a participant reported as angioedema-free in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit. This analysis was performed on mITT population. | ||||||||||||||||||||
End point type | Secondary | ||||||||||||||||||||
End point timeframe | From Week 4 to Week 12 | ||||||||||||||||||||
| |||||||||||||||||||||
Notes [5] - Data is presented for the participants available at the time of assessment. [6] - Data is presented for the participants available at the time of assessment. [7] - Data is presented for the participants available at the time of assessment. [8] - Data is presented for the participants available at the time of assessment. | |||||||||||||||||||||
Statistical analysis title | Percentage of angioedema-free days from W4 to W12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 75 mg | ||||||||||||||||||||
Number of subjects included in analysis | 141 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.1361 | ||||||||||||||||||||
Method | Wilcoxon (Mann-Whitney) | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | 90 | ||||||||||||||||||||
upper limit | 97 | ||||||||||||||||||||
Statistical analysis title | Percentage of angioedema-free days from W4 to W12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 150 mg | ||||||||||||||||||||
Number of subjects included in analysis | 144 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | = 0.0905 | ||||||||||||||||||||
Method | Wilcoxon (Mann-Whitney) | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | 87.6 | ||||||||||||||||||||
upper limit | 95.6 | ||||||||||||||||||||
Statistical analysis title | Percentage of angioedema-free days from W4 to W12 | ||||||||||||||||||||
Comparison groups | Placebo v Omalizumab 300 mg | ||||||||||||||||||||
Number of subjects included in analysis | 144 | ||||||||||||||||||||
Analysis specification | Pre-specified | ||||||||||||||||||||
Analysis type | other | ||||||||||||||||||||
P-value | < 0.0001 | ||||||||||||||||||||
Method | Wilcoxon (Mann-Whitney) | ||||||||||||||||||||
Confidence interval | |||||||||||||||||||||
level | 95% | ||||||||||||||||||||
sides | 2-sided | ||||||||||||||||||||
lower limit | 92.1 | ||||||||||||||||||||
upper limit | 98.8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events | Up to 28 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description | Safety evaluable set: All randomized participants who received at least one dose of study drug (omalizumab or the placebo). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type | Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name | MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version | 15.0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Placebo | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | Participants received only placebo injections (i.e., no active treatment) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Omalizumab 75 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | Participants received at least one 75 mg omalizumab injection, but no higher active dose level (150 mg or 300 mg) injections during the treatment period. Six participants were randomized to the Omalizumab 75 mg group received at least one dose of omalizumab 150 mg during the treatment period and were therefore included in the Omalizumab 150 mg group. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Omalizumab 150 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | Participants who received at least one 150 mg omalizumab injection but no higher active dose level (300 mg) injections during the treatment period. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title | Omalizumab 300 mg | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description | Participants received at least one 300 mg omalizumab injection during the treatment period. Two participants were randomized to the Omalizumab 300 mg group; however, they received one dose of omalizumab 150 mg during the treatment period. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) | |||
Were there any global substantial amendments to the protocol? Yes | |||
Date | Amendment | ||
11 Jan 2011 | The purpose of the protocol amendment on 11 January 2011 was to modify the study design according to recommendations by the FDA, internal Genentech staff, and external experts. Secondary objective was modified as to provide information about recurrence of disease after withdrawal of omalizumab in participants with refractory CIU. The second treatment period, including the re-randomization portion was removed, accordingly secondary end-points were modified. The planned number of participants within each treatment group were changed from 80 in the Omalizumab treatment group and 60 in the Placebo group to 75 per group. The screening period was modified from 14−18 to 12−18 days prior to Day 1. Post-hoc analyses were conducted on the number of participants who achieved a complete response (UAS7 = 0), at Week 12 and at Week 28. | ||
Interruptions (globally) | |||
Were there any global interruptions to the trial? No | |||
Limitations and caveats | |||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references | |||
http://www.ncbi.nlm.nih.gov/pubmed/25046337 |