Back to resultsEfficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
Primary Purpose
Chronic Urticaria
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Omalizumab 75-375 mg
Placebo to omalizumab
Loratadine
Clemastine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Urticaria focused on measuring Chronic urticaria, omalizumab, thyroperoxidase, IgE
Eligibility Criteria
Inclusion criteria:
- Males or females from 18-70 years of age
- Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL
- Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening
- Diagnosis of moderate to severe chronic urticaria
- Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening
- Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer
- Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period
- UAS7 ≥ 10 at the time of randomization
Exclusion criteria:
- Females of child-bearing potential or breast feeding
- Present or past medical conditions that could have interfered with the study results
- Randomized into any other omalizumab study or who had received omalizumab
- Received investigational drugs within 30 days of enrollment
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omalizumab 75-375 mg
Placebo to omalizumab
Arm Description
Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Outcomes
Primary Outcome Measures
Change in the Weekly Urticaria Activity Score (UAS7) From 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. 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 Outcome Measures
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.
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)
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.
Use of Concomitant and Rescue Medications
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.
Change in the Dermatology Life Quality Index (DLQI) Score From 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.
Change in the Skindex Score From 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.
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From 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.
Patient's Global Assessment of Their Chronic Urticaria Symptoms
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.
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00481676
Brief Title
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
Official Title
A Randomized, 24 Weeks, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Adult Patients With Chronic Urticaria Who Exhibit IgE Against Thyroperoxidase
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria
Keywords
Chronic urticaria, omalizumab, thyroperoxidase, IgE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omalizumab 75-375 mg
Arm Type
Experimental
Arm Description
Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Arm Title
Placebo to omalizumab
Arm Type
Placebo Comparator
Arm Description
Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
Intervention Type
Drug
Intervention Name(s)
Omalizumab 75-375 mg
Other Intervention Name(s)
Xolair
Intervention Description
Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection.
Intervention Type
Drug
Intervention Name(s)
Placebo to omalizumab
Intervention Description
Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection.
Intervention Type
Drug
Intervention Name(s)
Loratadine
Other Intervention Name(s)
Lorano®
Intervention Description
All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
Intervention Type
Drug
Intervention Name(s)
Clemastine
Other Intervention Name(s)
Tavegil®
Intervention Description
All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
Primary Outcome Measure Information:
Title
Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)
Description
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.
Time Frame
Baseline to end of the study (Week 24)
Secondary Outcome Measure Information:
Title
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Description
Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.
Time Frame
At the end of the study (Week 24)
Title
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)
Description
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.
Time Frame
Baseline to the end of the study (Week 24)
Title
Use of Concomitant and Rescue Medications
Description
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.
Time Frame
At Weeks 4, 8, 12, 16, 20, and 24
Title
Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)
Description
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.
Time Frame
Baseline to the end of the study (Week 24)
Title
Change in the Skindex Score From Baseline to the End of the Study (Week 24)
Description
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.
Time Frame
Baseline to the end of the study (Week 24)
Title
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
Description
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.
Time Frame
Baseline to the end of the study (Week 24)
Title
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Description
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.
Time Frame
At Baseline and at the end of the study (Week 24)
Title
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
Description
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.
Time Frame
At Baseline and at the end of the study (Week 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Males or females from 18-70 years of age
Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL
Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening
Diagnosis of moderate to severe chronic urticaria
Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening
Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer
Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period
UAS7 ≥ 10 at the time of randomization
Exclusion criteria:
Females of child-bearing potential or breast feeding
Present or past medical conditions that could have interfered with the study results
Randomized into any other omalizumab study or who had received omalizumab
Received investigational drugs within 30 days of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigative Site
City
Giessen
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Luebeck
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
Country
Germany
Facility Name
Novartis Investigative Site
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
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