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This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.
This study will be conducted using a double-blind, placebo-controlled, randomized, multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or inhibiting the occurrence, time-course and severity of angioedema episodes.
Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed by an 8-week follow-up. The study aims to enroll approximately 70 patients.
The study is divided into a 2-week screening period, a 28-week double-blind treatment phase with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Omalizumab | Experimental | omalizumab once a month via subcutaneous injection. |
|
| 2 Placebo | Placebo Comparator | placebo of omalizumab once a month via subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Biological | Humanized monoclonal antibody against human IgE |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) | The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants 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). An overall score is calculated and normalized to a scale of 1 to 100. | Baseline, 4, 12, 20, 28 and 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation) | Baseline, week 28; and the follow-up period (weeks 29-36) | |
| Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes | Baseline to week 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Mannheim | Baden-Wurttemberg | 68305 | Germany | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27010957 | Derived | Staubach P, Metz M, Chapman-Rothe N, Sieder C, Brautigam M, Canvin J, Maurer M. Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial. Allergy. 2016 Aug;71(8):1135-44. doi: 10.1111/all.12870. Epub 2016 Mar 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab | Omalizumab once a month via subcutaneous injection. |
| FG001 | Placebo | Placebo of omalizumab once a month via subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo to omalizumab |
|
|
| Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) | A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. min. score = 0 ; max. score= 100 | Baseline to week 28; and follow-up period (to week 36) |
| Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) | data points per group | week -2 to -1 |
| Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) | data points per group | weeks 25 to 28 |
| Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) | data points per group | weeks 33 to 36 |
| Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) | data points per group | weeks -2 to -1 |
| Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) | data points per group | weeks 25 to 28 |
| Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) | data points per group | weeks 33 to 36 |
| Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) | The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement. Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respectively. The total score is calculated, which is then transformed into a linear scale that ranges from 0 to 100, with a score of 100 indicating the worst possible impairment of HRQoL | baseline to week 28; and then follow-up to week 36 |
| Rescue Medication During the Treatment Period | baseline to 28 weeks |
| Days of Rescue Medication During the Treatment Period | data points per group | baseline to 28 weeks |
| Days of Rescue Medication During the Follow-up Period | data points per group | weeks 33 to 36 |
| Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) | The UAS7 is the sum of urticaria activity scores over a seven day period. The possible range of the weekly UAS7 score is 0-42. 0 means complete response and a better outcome and 42 means no response and a worse outcome. Complete UAS7 response is defined as UAS7=0. The UAS7 is the sum of the Hive Severity Score over seven days (HSS7) and the Itch Severity Score over seven days (ISS7) . The Hive Severity Score has a scale of 0 (none) to 3 (intense/severe). Complete hives response is defined as HSS7=0. The Itch Severity Score has a scale of 0 (None) to 3 (Severe (difficult to tolerate)). Complete itch response is defined as ISS7=0 | baseline to week 28; and then follow-up to week 36 |
| Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) | change in Dermatology Quality of Life Index scores The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | baseline to week 28; and follow-up to week 36 |
| Regensburg |
| Bavaria |
| 93053 |
| Germany |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Novartis Investigative Site | Aachen | 52074 | Germany |
| Novartis Investigative Site | Augsburg | 86179 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Bochum | 44791 | Germany |
| Novartis Investigative Site | Bonn | 53105 | Germany |
| Novartis Investigative Site | Darmstadt | 64283 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Gera | 07548 | Germany |
| Novartis Investigative Site | Halle | 06120 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Homburg | 66421 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Oldenburg | 26133 | Germany |
| Novartis Investigative Site | Selters | 56242 | Germany |
| Novartis Investigative Site | Wiesbaden | 65199 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab | Omalizumab once a month via subcutaneous injection. |
| BG001 | Placebo | Placebo of omalizumab once a month via subcutaneous injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| BMI group | Body Mass Index group | Count of Participants | Participants |
| |||||||||||||||
| Smoking status | Count of Participants | Participants |
| ||||||||||||||||
| Disease history and baseline characteristics of angioedema (FAS) | Frequency of prior angioedema episodes | Count of Participants | Participants |
| |||||||||||||||
| [Disease history and baseline characteristics of angioedema (FAS)] | Duration of symptoms of angioedema (usually) | Count of Participants | Participants |
| |||||||||||||||
| Disease history and baseline characteristics of angioedema (FAS) | Location of prior angioedema (any) | Number | participants |
| |||||||||||||||
| Disease history and baseline charactaristics | Duration of disease before baseline | Mean | Standard Deviation | years |
| ||||||||||||||
| Disease history and baseline charactaristics | Duration of disease group - n | Count of Participants | Participants |
| |||||||||||||||
| Disease history and baseline charactaristics | Previous systemic corticosteroid use - n | Count of Participants | Participants |
| |||||||||||||||
| Disease history and baseline charactaristics | Previous number of nsH1-n antihistamines - n | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) | The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants 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). An overall score is calculated and normalized to a scale of 1 to 100. | full analysis set | Posted | Mean | Standard Deviation | score | Baseline, 4, 12, 20, 28 and 36 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation) | full analysis set | Posted | Mean | Standard Deviation | days | Baseline, week 28; and the follow-up period (weeks 29-36) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes | full analysis set | Posted | Mean | Standard Deviation | days | Baseline to week 28 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation) | A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary. min. score = 0 ; max. score= 100 | full analysis set | Posted | Mean | Standard Deviation | AAS (Angioedema Activity Score) | Baseline to week 28; and follow-up period (to week 36) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1) | data points per group | full analysis set | Posted | Number | Number of episodes | week -2 to -1 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28) | data points per group | actual patient numbers | Posted | Number | Number of episodes | weeks 25 to 28 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36) | data points per group | full analysis set | Posted | Number | Number of episodes | weeks 33 to 36 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1) | data points per group | full analysis set | Posted | Number | number of episodes | weeks -2 to -1 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28) | data points per group | full analysis set | Posted | Number | Number of episodes | weeks 25 to 28 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36) | data points per group | full analysis set | Posted | Number | Number of episodes | weeks 33 to 36 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) | The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement. Each AE-QoL question has 5 answer options (scored 1-5), with lower and higher scores indicting less and more adverse impact, respectively. The total score is calculated, which is then transformed into a linear scale that ranges from 0 to 100, with a score of 100 indicating the worst possible impairment of HRQoL | full analysis set | Posted | Mean | Standard Deviation | AE-QoL Score | baseline to week 28; and then follow-up to week 36 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Rescue Medication During the Treatment Period | safety set | Posted | Number | participants | baseline to 28 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Days of Rescue Medication During the Treatment Period | data points per group | safety set | Posted | Number | days | baseline to 28 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Days of Rescue Medication During the Follow-up Period | data points per group | safety set | Posted | Number | days | weeks 33 to 36 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) | The UAS7 is the sum of urticaria activity scores over a seven day period. The possible range of the weekly UAS7 score is 0-42. 0 means complete response and a better outcome and 42 means no response and a worse outcome. Complete UAS7 response is defined as UAS7=0. The UAS7 is the sum of the Hive Severity Score over seven days (HSS7) and the Itch Severity Score over seven days (ISS7) . The Hive Severity Score has a scale of 0 (none) to 3 (intense/severe). Complete hives response is defined as HSS7=0. The Itch Severity Score has a scale of 0 (None) to 3 (Severe (difficult to tolerate)). Complete itch response is defined as ISS7=0 | full analysis set | Posted | Mean | Standard Deviation | scores on a scale | baseline to week 28; and then follow-up to week 36 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases) | change in Dermatology Quality of Life Index scores The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | full analysis set | Posted | Mean | Standard Deviation | DLQI Score | baseline to week 28; and follow-up to week 36 |
|
|
Not provided
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omalizumab | Omalizumab once a month via subcutaneous injection. | 4 | 44 | 19 | 44 | ||
| EG001 | Placebo | Placebo of omalizumab once a month via subcutaneous injection | 2 | 47 | 29 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Publications from a single-site are postponed until publication of the pooled clinical trial data (i.e., data from all sites) or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 1-888-669-6682 |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Other |
|
| 18.5-25 |
|
| >25 |
|
| Current smoker |
|
| Ex-smoker |
|
| Weekly |
|
| >6 episodes per year |
|
| <6 episodes a year |
|
| >24 hours |
|
| Lips/perioral |
|
| Mouth/laryngeal |
|
| Trunk |
|
| Arms/legs |
|
| Hands |
|
| 2-10 years |
|
| >10 years |
|
| Yes |
|
| 3-5 years |
|
| >5 years |
|
| V7 (week 20) |
|
| V9 (week 28) |
|
| Follow-up (week 36) |
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
| Participants |
|
|