Trial · NCT01264939
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
NCT01264939, Phase 3, Completed, Genentech, Inc.; results first posted 2013-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists. Trials, record NCT01264939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01264939
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
- NCT number
- NCT01264939
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 336 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Chronic Idiopathic Urticaria
- Interventions
- Omalizumab, Placebo, H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist, Diphenhydramine
- First posted
- 2010-12-22
- Last updated
- 2013-11-26
- Results first posted
- 2013-11-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | Baseline to the end of study (up to 40 weeks) | The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below. |
| Secondary | Change From Baseline to Week 12 in the Weekly Itch Severity Score | Baseline to Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7) | Baseline to Week 12 | The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement. |
| Secondary | Change From Baseline to Week 12 in the Weekly Number of Hives Score | Baseline to Week 12 | The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (\> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement. |
| Secondary | Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 | Baseline to Week 12 | The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score. 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. |
| Secondary | Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 | Week 12 | The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. |
| Secondary | Percentage of Weekly Itch Severity Score MID Responders at Week 12 | Baseline to Week 12 | The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline. 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. |
| Secondary | Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score | Baseline to Week 12 | The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (\> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size. |
| Secondary | Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 | Baseline to Week 12 | The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated 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 (Very much). 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. |
| Secondary | Percentage of Angioedema-free Days From Week 4 to Week 12 | Week 4 to Week 12 | The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded "No" to the angioedema question 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. |
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 |
|---|---|---|---|---|---|
| SECONDARY | Change From Baseline to Week 12 in the Weekly Itch Severity Score | Baseline to Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7) | Baseline to Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Weekly Number of Hives Score | Baseline to Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. | Units on a scale | MEAN |
| SECONDARY | Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 | Baseline to Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Only patients with a MID response were included in the analysis. | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 | Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Weekly Itch Severity Score MID Responders at Week 12 | Baseline to Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score | Baseline to Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 | Baseline to Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug and who had a DLQI score at Week 12. | Units on a scale | MEAN |
| SECONDARY | Percentage of Angioedema-free Days From Week 4 to Week 12 | Week 4 to Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis. | Percentage of days | MEAN |
| SECONDARY | Percentage of Complete Responders (UAS7 = 0) at Week 12 | Week 12 | Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in the Weekly Itch Severity Score | Placebo | -4.01 | Standard Deviation 5.87 | Units on a scale | |
| Change From Baseline to Week 12 in the Weekly Itch Severity Score | Omalizumab 300 mg | -8.55 | Standard Deviation 6.01 | Units on a scale | |
| Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7) | Placebo | -8.50 | Standard Deviation 11.71 | Units on a scale | |
| Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7) | Omalizumab 300 mg | -19.01 | Standard Deviation 13.15 | Units on a scale | |
| Change From Baseline to Week 12 in the Weekly Number of Hives Score | Placebo | -4.49 | Standard Deviation 6.33 | Units on a scale | |
| Change From Baseline to Week 12 in the Weekly Number of Hives Score | Omalizumab 300 mg | -10.46 | Standard Deviation 7.74 | Units on a scale | |
| Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 | Placebo | 5.0 | 95% Confidence Interval 3.0 to 7.0 | Weeks | |
| Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 | Omalizumab 300 mg | 2.0 | 95% Confidence Interval 1.0 to 2.0 | Weeks | |
| Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 | Placebo | 12.0 | Percentage of participants | ||
| Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 | Omalizumab 300 mg | 52.4 | Percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 84 | |
| Overall Study | STARTED | Omalizumab 300 mg | 252 | |
| Overall Study | COMPLETED | Placebo | 66 | |
| Overall Study | COMPLETED | Omalizumab 300 mg | 224 | |
| Overall Study | NOT COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Omalizumab 300 mg | 28 |
Source ClinicalTrials.gov
Adverse events68
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 | Nausea | Gastrointestinal disorders | Placebo | 5 | 83 | |
| other | Nausea | Gastrointestinal disorders | Omalizumab 300 mg | 15 | 252 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 83 | |
| other | Diarrhoea | Gastrointestinal disorders | Omalizumab 300 mg | 13 | 252 | |
| other | Sinusitis | Infections and infestations | Placebo | 9 | 83 | |
| other | Sinusitis | Infections and infestations | Omalizumab 300 mg | 31 | 252 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 8 | 83 | |
| other | Nasopharyngitis | Infections and infestations | Omalizumab 300 mg | 30 | 252 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 4 | 83 | |
| other | Upper respiratory tract infection | Infections and infestations | Omalizumab 300 mg | 29 | 252 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Omalizumab 300 mg | ||
| Total, other adverse events | Placebo | 41 | 83 |
| Total, other adverse events | Omalizumab 300 mg | 142 | 252 |
| Total, serious adverse events | Placebo | 5 | 83 |
| Total, serious adverse events | Omalizumab 300 mg | 18 | 252 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Omalizumab 300 mg vs Placebo: serious adverse events |
Source Trial comparisons
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01264939/results?page=2