Trial · NCT00866788
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
NCT00866788, Phase 2, Completed, Genentech, Inc.; results first posted 2011-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1). Trials, record NCT00866788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866788
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
- NCT number
- NCT00866788
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Chronic Idiopathic Urticaria
- Interventions
- omalizumab, placebo, H1 antihistamines, Diphenhydramine
- First posted
- 2009-03-23
- Last updated
- 2017-07-11
- Results first posted
- 2011-09-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 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. | scores on a scale | MEAN |
| SECONDARY | 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) | 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. | scores on a scale | MEAN |
| SECONDARY | 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) | 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. | scores on a scale | MEAN |
| SECONDARY | 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) | 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. | scores on a scale | MEAN |
| SECONDARY | 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) | 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. | Pills | MEAN |
| SECONDARY | Number of Patients With Adverse Events by Severity | 16 weeks overall (data reported separately for up to 4 weeks and Weeks 5 to 16) | Safety-Evaluable Population, which included all randomized patients who received any study drug. number (n) equals (=) number of participants analyzed in the specified category. | participants | NUMBER |
| SECONDARY | Number of Participants With Immunogenicity | 16 weeks | Safety-Evaluable Population | participants | NUMBER |
| SECONDARY | 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) | 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. | micrograms per milliliter (µg/mL) | MEAN |
| SECONDARY | 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) | Pharmacokinetic-Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure. | days | MEAN |
| SECONDARY | 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) | Pharmacokinetic-Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure. | µg*day/mL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | Placebo | -6.91 | Standard Deviation 9.84 | scores on a scale | |
| Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | Omalizumab 75 mg | -9.79 | Standard Deviation 11.75 | scores on a scale | |
| Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | Omalizumab 300 mg | -19.93 | Standard Deviation 12.38 | scores on a scale | |
| Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | Omalizumab 600 mg | -14.56 | Standard Deviation 10.17 | scores on a scale | |
| Change in the Weekly Pruritus Score From Baseline to Week 4 | Placebo | -3.45 | Standard Deviation 5.22 | scores on a scale | |
| Change in the Weekly Pruritus Score From Baseline to Week 4 | Omalizumab 75 mg | -4.50 | Standard Deviation 5.84 | scores on a scale | |
| Change in the Weekly Pruritus Score From Baseline to Week 4 | Omalizumab 300 mg | -9.22 | Standard Deviation 5.98 | scores on a scale | |
| Change in the Weekly Pruritus Score From Baseline to Week 4 | Omalizumab 600 mg | -6.46 | Standard Deviation 5.63 | scores on a scale | |
| Change in the Weekly Score for Number of Hives From Baseline to Week 4 | Placebo | -3.46 | Standard Deviation 5.17 | scores on a scale | |
| Change in the Weekly Score for Number of Hives From Baseline to Week 4 | Omalizumab 75 mg | -5.28 | Standard Deviation 6.91 | scores on a scale |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 21 | |
| Overall Study | STARTED | Omalizumab 75 mg | 23 | |
| Overall Study | STARTED | Omalizumab 300 mg | 25 | |
| Overall Study | STARTED | Omalizumab 600 mg | 21 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | COMPLETED | Omalizumab 75 mg | 17 | |
| Overall Study | COMPLETED | Omalizumab 300 mg | 23 | |
| Overall Study | COMPLETED | Omalizumab 600 mg | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Omalizumab 75 mg | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 0 | 21 | |
| other | Upper respiratory tract infection | Infections and infestations | Omalizumab 75 mg | 2 | 23 | |
| other | Upper respiratory tract infection | Infections and infestations | Omalizumab 300 mg | 3 | 25 | |
| other | Upper respiratory tract infection | Infections and infestations | Omalizumab 600 mg | 2 | 21 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 21 | |
| other | Nasopharyngitis | Infections and infestations | Omalizumab 75 mg | 4 | 23 | |
| other | Nasopharyngitis | Infections and infestations | Omalizumab 300 mg | 3 | 25 | |
| other | Nasopharyngitis | Infections and infestations | Omalizumab 600 mg | 1 | 21 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 21 | |
| other | Headache | Nervous system disorders | Omalizumab 75 mg | 0 | 23 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Omalizumab 75 mg | ||
| Total, all-cause mortality | Omalizumab 300 mg | ||
| Total, all-cause mortality | Omalizumab 600 mg | ||
| Total, other adverse events | Placebo | 5 | 21 |
| Total, other adverse events | Omalizumab 75 mg | 9 | 23 |
| Total, other adverse events | Omalizumab 300 mg | 11 | 25 |
| Total, other adverse events | Omalizumab 600 mg | 8 | 21 |
| Total, serious adverse events | Placebo | 0 | 21 |
| Total, serious adverse events | Omalizumab 75 mg | 0 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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