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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003683-31 | EudraCT Number |
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The study was prematurely terminated after core study CQGE031B2201 failed to meet the primary objective of demonstrating superiority for QGE031 versus placebo.
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This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.
This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QGE031 every 4 weeks (q4w) | Experimental | QGE031 240 mg subcutaneously q4w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QGE031 | Drug | QGE031 120 mg/mL solution for subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | Safety was monitored throughout the study. | 52 weeks |
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Key Inclusion Criteria:
Key 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 | Evansville | Indiana | 47713 | United States | ||
| Novartis Investigative Site |
This was an open-label, single arm study for participants who completed the core study CQGE031B2201 (NCT01716754).
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| ID | Title | Description |
|---|---|---|
| FG000 | QGE031 Every 4 Weeks (q4w) | QGE031 240 mg subcutaneously q4w |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Owensboro |
| Kentucky |
| 42301 |
| United States |
| Novartis Investigative Site | Waldorf | Maryland | 20602 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55402 | United States |
| Novartis Investigative Site | Fairfax | Virginia | 22030 | United States |
| Novartis Investigative Site | CABA | Buenos Aires | C1122AAK | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1426ABP | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires F.D. | C1430CKE | Argentina |
| Novartis Investigative Site | Santa Fe | Rosario | S2000DBS | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000AII | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Novartis Investigative Site | Buenos Aires | C1125ABE | Argentina |
| Novartis Investigative Site | Mendoza | M5500CBA | Argentina |
| Novartis Investigative Site | Mendoza | M5500FIK | Argentina |
| Novartis Investigative Site | Santa Fe | S3000FIL | Argentina |
| Novartis Investigative Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3G 1L5 | Canada |
| Novartis Investigative Site | Québec | G1V 4W2 | Canada |
| Novartis Investigative Site | Trutnov | Czech Republic | 541 01 | Czechia |
| Novartis Investigative Site | Teplice | CZE | 415 01 | Czechia |
| Novartis Investigative Site | Brno | 615 00 | Czechia |
| Novartis Investigative Site | Břeclav | 690 02 | Czechia |
| Novartis Investigative Site | Tábor | 390 01 | Czechia |
| Novartis Investigative Site | Tampere | 33520 | Finland |
| Novartis Investigative Site | Turku | 20521 | Finland |
| Novartis Investigative Site | Le Kremlin | 94275 | France |
| Novartis Investigative Site | Montpellier | 34059 | France |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Leipzig | 04275 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Rüdersdorf | 15562 | Germany |
| Novartis Investigative Site | Budapest | 1121 | Hungary |
| Novartis Investigative Site | Pécs | 7635 | Hungary |
| Novartis Investigative Site | Törökbálint | 2045 | Hungary |
| Novartis Investigative Site | Jerusalem | 91031 | Israel |
| Novartis Investigative Site | Jerusalem | 9112001 | Israel |
| Novartis Investigative Site | Kfar Saba | 4428164 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Rehovot | 7610001 | Israel |
| Novartis Investigative Site | Messina | ME | 98125 | Italy |
| Novartis Investigative Site | Milan | MI | 20123 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Verona | VR | 37126 | Italy |
| Novartis Investigative Site | Guadalajara | Jalisco | 44130 | Mexico |
| Novartis Investigative Site | Bialystok | 15-276 | Poland |
| Novartis Investigative Site | Lodz | 90-153 | Poland |
| Novartis Investigative Site | Coimbra | 3041-853 | Portugal |
| Novartis Investigative Site | Lisbon | 1749-035 | Portugal |
| Novartis Investigative Site | Porto | 4100-180 | Portugal |
| Novartis Investigative Site | Bucharest | ROM | 12071 | Romania |
| Novartis Investigative Site | Brasov | 500112 | Romania |
| Novartis Investigative Site | Brasov | 500281 | Romania |
| Novartis Investigative Site | Bucharest | 030317 | Romania |
| Novartis Investigative Site | Cluj-Napoca | 400371 | Romania |
| Novartis Investigative Site | Barnaul | 656045 | Russia |
| Novartis Investigative Site | Nizhny Novgorod | 603018 | Russia |
| Novartis Investigative Site | Ryazan | 390026 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194354 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Yaroslavl | 150003 | Russia |
| Novartis Investigative Site | Bratislava | Slovak Republic | 831 03 | Slovakia |
| Novartis Investigative Site | Nitra | Slovak Republic | 949 01 | Slovakia |
| Novartis Investigative Site | Bratislava | 826 06 | Slovakia |
| Novartis Investigative Site | Košice | 04001 | Slovakia |
| Novartis Investigative Site | Prievidza | 97101 | Slovakia |
| Novartis Investigative Site | Ružomberok | 034 26 | Slovakia |
| Novartis Investigative Site | Berea | Durban | 4001 | South Africa |
| Novartis Investigative Site | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Novartis Investigative Site | Suwon | Gyeonggi-do | 16499 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 08308 | South Korea |
| Novartis Investigative Site | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Novartis Investigative Site | Gwangju | 501-757 | South Korea |
| Novartis Investigative Site | Seoul | 120-752 | South Korea |
| Novartis Investigative Site | Seoul | 156-755 | South Korea |
| Novartis Investigative Site | Istanbul | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34854 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Mersin | 33079 | Turkey (Türkiye) |
| Novartis Investigative Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | Southampton | SO16 6YD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | QGE031 Every 4 Weeks (q4w) | QGE031 240 mg subcutaneously q4w |
| 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 | Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability | Safety was monitored throughout the study. | The safety set, which included all participants, was analyzed. | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QGE031 Every 4 Weeks (q4w) | QGE031 240 mg subcutaneously q4w | 19 | 270 | 130 | 270 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertebral artery thrombosis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000598891 | ligelizumab |
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| Title | Measurements |
|---|---|
|