Trial · NCT00481676
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
NCT00481676, Phase 2, Completed, Novartis; results first posted 2011-10-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria. Trials, record NCT00481676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00481676
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
- NCT number
- NCT00481676
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Chronic Urticaria
- Interventions
- Omalizumab 75-375 mg, Placebo to omalizumab, Loratadine, Clemastine
- First posted
- 2007-06-04
- Last updated
- 2011-10-21
- Results first posted
- 2011-10-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) | Baseline to end of the study (Week 24) | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement. |
| Secondary | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | At the end of the study (Week 24) | Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study. |
| Secondary | Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time. |
| Secondary | Use of Concomitant and Rescue Medications | At Weeks 4, 8, 12, 16, 20, and 24 | Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study. |
| Secondary | Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement. |
| Secondary | Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients' quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement. |
| Secondary | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement. |
| Secondary | Patient's Global Assessment of Their Chronic Urticaria Symptoms | At Baseline and at the end of the study (Week 24) | Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported. |
| Secondary | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | At Baseline and at the end of the study (Week 24) | The investigator made a global assessment of the patient's chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) | Baseline to end of the study (Week 24) | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Units on a scale | MEAN |
| SECONDARY | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | At the end of the study (Week 24) | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Participants | NUMBER |
| SECONDARY | Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Units on a scale | MEAN |
| SECONDARY | Use of Concomitant and Rescue Medications | At Weeks 4, 8, 12, 16, 20, and 24 | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Pills | MEAN |
| SECONDARY | Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Units on a scale | MEAN |
| SECONDARY | Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Units on a scale | MEAN |
| SECONDARY | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Units on a scale | MEAN |
| SECONDARY | Patient's Global Assessment of Their Chronic Urticaria Symptoms | At Baseline and at the end of the study (Week 24) | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Participants | NUMBER |
| SECONDARY | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | At Baseline and at the end of the study (Week 24) | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) | Omalizumab 75-375 mg | -17.8 | Standard Deviation 10.52 | Units on a scale | |
| Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) | Placebo to Omalizumab | -5.8 | Standard Deviation 11.52 | Units on a scale | |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Omalizumab 75-375 mg | Wheals - None | 19 | Participants | |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Placebo to Omalizumab | Wheals - None | 1 | Participants | |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Omalizumab 75-375 mg | Wheals - < 10 | 3 | Participants | |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Placebo to Omalizumab | Wheals - < 10 | 11 | Participants | |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Omalizumab 75-375 mg | Wheals - 10-50 | 1 | Participants | |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Placebo to Omalizumab | Wheals - 10-50 | 3 | Participants | |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Omalizumab 75-375 mg | Wheals - > 50 | 1 | Participants | |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Placebo to Omalizumab | Wheals - > 50 | 1 | Participants |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omalizumab 75-375 mg | 27 | |
| Overall Study | STARTED | Placebo to Omalizumab | 22 | |
| Overall Study | COMPLETED | Omalizumab 75-375 mg | 25 | |
| Overall Study | COMPLETED | Placebo to Omalizumab | 17 | |
| Overall Study | NOT COMPLETED | Omalizumab 75-375 mg | 2 | |
| Overall Study | NOT COMPLETED | Placebo to Omalizumab | 5 |
Source ClinicalTrials.gov
Adverse events34
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 | Abdominal Pain | Gastrointestinal disorders | Omalizumab 75-375 mg | 0 | 27 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo to Omalizumab | 2 | 22 | |
| other | Diarrhoea | Gastrointestinal disorders | Omalizumab 75-375 mg | 4 | 27 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo to Omalizumab | 2 | 22 | |
| other | Injection Site Pain | General disorders | Omalizumab 75-375 mg | 0 | 27 | |
| other | Injection Site Pain | General disorders | Placebo to Omalizumab | 1 | 22 | |
| other | Gastroenteritis | Infections and infestations | Omalizumab 75-375 mg | 2 | 27 | |
| other | Gastroenteritis | Infections and infestations | Placebo to Omalizumab | 0 | 22 | |
| other | Gastrointestinal Infection | Infections and infestations | Omalizumab 75-375 mg | 3 | 27 | |
| other | Gastrointestinal Infection | Infections and infestations | Placebo to Omalizumab | 2 | 22 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omalizumab 75-375 mg | ||
| Total, all-cause mortality | Placebo to Omalizumab | ||
| Total, other adverse events | Omalizumab 75-375 mg | 19 | 27 |
| Total, other adverse events | Placebo to Omalizumab | 12 | 22 |
| Total, serious adverse events | Omalizumab 75-375 mg | 0 | 27 |
| Total, serious adverse events | Placebo to Omalizumab | 2 | 22 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Omalizumab 75-375 mg vs Placebo to Omalizumab: 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.
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