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Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMALIZUMAB | Experimental | sub cutaneous injections of 300 mg every 4 weeks until Week 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMALIZUMAB | Drug | sub cutaneous injections of 300 mg every 4 weeks until Week 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 | Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12 The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | WEEK 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema | 2 patients with angioedema status were missing at baseline and not included | WEEK 12 |
| CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CLAIRE BERNIER TAUGOURDEAU | HOPITAL HOTEL DIEU - NANTES CEDEX 1 | Principal Investigator |
| PASCAL JOLY | HOPITAL CHARLES NICOLLE - ROUEN CEDEX | Principal Investigator |
| LUDOVIC MARTIN | HOTEL DIEU - ANGERS CEDEX 9 | Principal Investigator |
| GERARD GUILLET | CHR LA MILETRIE - POITIERS CEDEX | Principal Investigator |
| PATRICE PLANTIN | CHI DE CORNOUAILLE - QUIMPER CEDEX | Principal Investigator |
| ALAIN DUPUY | HOPITAL PONTCHAILLOU - RENNES CEDEX 9 | Principal Investigator |
| EVELYNE COLLET | CHU SITE DU BOCAGE - DIJON CEDEX | Principal Investigator |
| ANNICK BARBAUD | HOPITAUX DE BRABOIS - VANDOEUVRE LES NANCY CEDEX | Principal Investigator |
| ZIAD REGUIAI | HOPITAL ROBERT DEBRE - REIMS CEDEX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Paris | Cedex 10 | 75475 | France | ||
| Novartis Investigative Site |
Not provided
Full Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OMALIZUMAB | sub cutaneous injections of 300 mg every 4 weeks until Week 8 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease. Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42). |
| baseline and week 12 |
| Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 | The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12. The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease. A score of ≥12 indicates well-controlled urticaria. | baseline and week 12 |
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | week 16 |
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | week 20 |
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control | week 24 |
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | week 28 |
| The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire | The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12. The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life. | baseline and week 12 |
| The Angioedema Quality of Life (AE-QoL) | The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients. The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment | baseline and week 12 |
| The Dermatology Life Quality Index (DLQI) | The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). | baseline and week 12 |
| Angioedema Activity Using the Angioedema Activity Score (AAS) | The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity. | baseline and week 12 |
| FABIEN PELLETIER |
| HOPITAL JEAN MINJOZ - BESANCON CEDEX |
| Principal Investigator |
| DELPHINE STAUMONT SALLE | HOPITAL CLAUDE HURIEZ- LILLE CEDEX | Principal Investigator |
| JULIETTE JEGOU | CH DE CHALONS EN CHAMPAGNE - CHALONS EN CHAMPAGNE CEDEX | Principal Investigator |
| EMMANUELLE AMSLER | HOPITAL TENON - PARIS CEDEX 20 | Principal Investigator |
| OLIVIER CHOSIDOW | HOPITAL HENRI MONDOR - CRETEIL | Principal Investigator |
| VINCENT DESCAMPS | HOPITAL BICHAT CLAUDE BERNARD - PARIS CEDEX 18 | Principal Investigator |
| EMMANUEL MAHE | CH VICTOR DUPOUY - ARGENTEUIL CEDEX | Principal Investigator |
| LILIANE LAROCHE | HOPITAL AVICENNE - BOBIGNY CEDEX | Principal Investigator |
| GERMAINE GABISON | HOPITAL SAINT LOUIS - PARIS CEDEX 10 | Principal Investigator |
| SELIM ARACTINGI | HOPITAL COCHIN - PARIS | Principal Investigator |
| LAURENCE BOUILLET | CHU DE GRENOBLE - LA TRONCHE | Principal Investigator |
| JEAN-JACQUES GROB | HOPITAL TIMONE - MARSEILLE CEDEX 05 | Principal Investigator |
| FREDERIC CAMBAZARD | CHU SAINT ETIENNE - ST PRIEST EN JAREZ CEDEX | Principal Investigator |
| THIERRY BOYE | HIA SAINTE ANNE - TOULON CEDEX 9 | Principal Investigator |
| JEAN-PHILIPPE LACOUR | HOPITAL DE L'ARCHET - NICE CEDEX 3 | Principal Investigator |
| PHILIPPE BERBIS | HOPITAL NORD- MARSEILLE | Principal Investigator |
| LAURENT MEUNIER | HOPITAL CAREMEAU - NIMES CEDEX 9 | Principal Investigator |
| FRANCOISE GIORDANO LABADIE | HOPITAL LARREY - TOULOUSE CEDEX 9 | Principal Investigator |
| NADIA RAISON PEYRON | HOPITAL ST ELOI - MONTPELLIER CEDEX 5 | Principal Investigator |
| MARIE CHRISTINE FERRIER LE BOUEDEC | CHU ESTAING - CLERMONT FERRAND | Principal Investigator |
| MARIE SYLVIE DOUTRE | HOPITAL DE HAUT LEVEQUE - PESSAC CEDEX | Principal Investigator |
| BRIGITTE MILPIED | HOPITAL ST ANDRE - BORDEAUX CEDEX | Principal Investigator |
| CHRISTOPHE BEDANE | HOPITAL DUPUYTREN - LIMOGES CEDEX 1 | Principal Investigator |
| PHILIPPE MODIANO | HOPITAL ST VINCENT DE PAUL - LILLE CEDEX | Principal Investigator |
| Limoges |
| Haute Vienne |
| 87000 |
| France |
| Novartis Investigative Site | Toulon | Val De Marne | 83800 | France |
| Novartis Investigative Site | Angers | 49933 | France |
| Novartis Investigative Site | Argenteuil | 95107 | France |
| Novartis Investigative Site | Besançon | 25030 | France |
| Novartis Investigative Site | Bobigny | 93009 | France |
| Novartis Investigative Site | Bordeaux | 33075 | France |
| Novartis Investigative Site | Châlons-en-Champagne | 51005 | France |
| Novartis Investigative Site | Clermont-Ferrand | 63003 | France |
| Novartis Investigative Site | Dijon | 21034 | France |
| Novartis Investigative Site | Grenoble | 38043 | France |
| Novartis Investigative Site | Lille | 59000 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Lyon | 69317 | France |
| Novartis Investigative Site | Marseille | 13885 | France |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Nantes | 44035 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Nîmes | 30029 | France |
| Novartis Investigative Site | Paris | 75014 | France |
| Novartis Investigative Site | Paris | 75877 | France |
| Novartis Investigative Site | Quimper | 29000 | France |
| Novartis Investigative Site | Reims | 51090 | France |
| Novartis Investigative Site | Rennes | 35033 | France |
| Novartis Investigative Site | Rouen | 76031 | France |
| Novartis Investigative Site | Saint-Etienne | 42055 | France |
| Novartis Investigative Site | Toulouse | 31400 | France |
| Novartis Investigative Site | Vandœuvre-lès-Nancy | 54511 | France |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OMALIZUMAB | sub cutaneous injections of 300 mg every 4 weeks until Week 8 |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | 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 | Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 | Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12 The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | (Full analysis set, LOCF) | Posted | Number | 95% Confidence Interval | percent of participants | WEEK 12 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema | 2 patients with angioedema status were missing at baseline and not included | Full Analysis Set 2 patients with angioedema status missing at baseline were not included so that FAS = 83 + 51 + 2= 136 | Posted | Number | 95% Confidence Interval | percent of participants | WEEK 12 |
|
| ||||||||||||||||||||||||||
| Secondary | CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema | A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease. Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42). | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | scores on a scale | baseline and week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 | The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12. The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease. A score of ≥12 indicates well-controlled urticaria. | FAS | Posted | Mean | Standard Deviation | scores on a scale | baseline and week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | FAS | Posted | Mean | Standard Deviation | scores on a scale | week 16 |
|
| ||||||||||||||||||||||||||
| Secondary | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | FAS | Posted | Mean | Standard Deviation | scores on a scale | week 20 |
|
| ||||||||||||||||||||||||||
| Secondary | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control | FAS | Posted | Mean | Standard Deviation | scores on a scale | week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. | FAS | Posted | Mean | Standard Deviation | scores on a scale | week 28 |
|
| ||||||||||||||||||||||||||
| Secondary | The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire | The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12. The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life. | FAS | Posted | Mean | Standard Deviation | scores on a scale | baseline and week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | The Angioedema Quality of Life (AE-QoL) | The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients. The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment | FAS | Posted | Mean | Standard Deviation | scores on a scale | baseline and week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | The Dermatology Life Quality Index (DLQI) | The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). | FAS | Posted | Mean | Standard Deviation | scores on a scale | baseline and week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Angioedema Activity Using the Angioedema Activity Score (AAS) | The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity. | FAS | Posted | Mean | Standard Deviation | scores on a scale | baseline and week 12 |
|
|
Adverse events were collected from first dose of study treatment until end of study treatment at week 12
An adverse event (AE) is any sign or symptom that occurs during the study treatment plus the # days post treatment
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 300 mg | Omalizumab 300 mg | 9 | 136 | 44 | 136 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMONIA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| FRACTURED SACRUM | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| OBESITY | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| FOOT DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| SACROILIITIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| BLADDER DILATATION | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PHARYNGEAL OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ASTHENIA | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
No placebo arm and limited duration of the study (3 months for the main period)
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | (862) 778-8300 |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| 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 |
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
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