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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003636-13 | EudraCT Number |
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A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ligelizumab | Experimental | QGE031 240 mg s.c. q4w x 13 treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligelizumab | Biological | QGE031 240 mg s.c. q4w |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Event (AE) | The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest. | Within 16 weeks after Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Having Achieved UAS7 ≤ 6 | The secondary objective of this study was to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations: Sustained remission defined as maintaining (Urticaria Activity Score) UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch. |
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Inclusion Criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
Exclusion Criteria:
Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36440464 | Derived | Metz M, Bernstein JA, Gimenez-Arnau AM, Hide M, Maurer M, Sitz K, Soong W, Sussman G, Hua E, Barve A, Barbier N, Balp MM, Severin T. Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria. World Allergy Organ J. 2022 Nov 15;15(11):100716. doi: 10.1016/j.waojou.2022.100716. eCollection 2022 Nov. | |
| 34773261 |
| Label | URL |
|---|---|
| Core study | View source |
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Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Of the subjects who completed core study (NCT02477332) that were eligible for extension study, 237 were screened; 226 were enrolled to open-label treatment epoch; 201 (88.9%) completed treatment epoch; 209 (92.5%) entered the post-treatment follow-up epoch and 152 (67.3%) completed the post-treatment follow-up epoch
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| ID | Title | Description |
|---|---|---|
| FG000 | Ligelizumab | QGE031 240 mg s.c. q4w x 13 treatments |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2015 | Apr 28, 2020 |
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| Baseline, Week 52 and Week 100 |
| Number and Proportion of Participants Who Achieved UAS7≤ 6 | Summary of subjects with UAS7 ≤ 6. The long term efficacy of one-year treatment of ligelizumab 240 mg s.c. q4w is assessed by number and proportion of participants who achieved well controlled disease (UAS7≤ 6) at end of the treatment period (Week 52) and end of follow up period (Week 100). | Baseline, Week 52, Week 100 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34233 | United States |
| Novartis Investigative Site | Evansville | Indiana | 47713 | United States |
| Novartis Investigative Site | Owensboro | Kentucky | 42301 | United States |
| Novartis Investigative Site | Waldorf | Maryland | 20602 | United States |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45231 | United States |
| Novartis Investigative Site | Toledo | Ohio | 43617 | United States |
| Novartis Investigative Site | Lake Oswego | Oregon | 97035 | United States |
| Novartis Investigative Site | Providence | Rhode Island | 02906 | United States |
| Novartis Investigative Site | Dallas | Texas | 75230 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76132 | United States |
| Novartis Investigative Site | South Burlington | Vermont | 05403 | United States |
| Novartis Investigative Site | Campbelltown | New South Wales | 2560 | Australia |
| Novartis Investigative Site | Sydney | New South Wales | 2010 | Australia |
| Novartis Investigative Site | Woolloongabba | Queensland | 4102 | Australia |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | East Melbourne | Victoria | 3002 | Australia |
| Novartis Investigative Site | Toronto | Ontario | M4V 1R2 | Canada |
| Novartis Investigative Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Novartis Investigative Site | Québec | G1V 4W2 | Canada |
| Novartis Investigative Site | Munich | Bavaria | 80377 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Athens | GR | 115 27 | Greece |
| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Athens | 12462 | Greece |
| Novartis Investigative Site | Obihiro | Hokkaido | 080 0013 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0017 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 221-0825 | Japan |
| Novartis Investigative Site | Kamimashi-gun | Kumamoto | 861-3101 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 602-8566 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 593-8324 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 330-0854 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 194-0013 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 143-0023 | Japan |
| Novartis Investigative Site | Shinagawa Ku | Tokyo | 141 8625 | Japan |
| Novartis Investigative Site | Hiroshima | 734-8551 | Japan |
| Novartis Investigative Site | Chelyabinsk | 454092 | Russia |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194223 | Russia |
| Novartis Investigative Site | Saint Petersburg | 195112 | Russia |
| Novartis Investigative Site | Smolensk | 214019 | Russia |
| Novartis Investigative Site | Córdoba | Andalusia | 14004 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29009 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41009 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Alcorcón | Madrid | 28922 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03010 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46015 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Taoyuan | Taiwan | 333 | Taiwan |
| Novartis Investigative Site | Taichung | 407 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Yeovil | Somerset | BA21 4AT | United Kingdom |
| Maurer M, Gimenez-Arnau A, Bernstein JA, Chu CY, Danilycheva I, Hide M, Makris M, Metz M, Savic S, Sitz K, Soong W, Staubach P, Sussman G, Barve A, Burciu A, Hua E, Janocha R, Severin T. Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study. Allergy. 2022 Jul;77(7):2175-2184. doi: 10.1111/all.15175. Epub 2021 Nov 22. |
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
| COMPLETED |
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| NOT COMPLETED |
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The Safety set (SS) included all subjects who received at least one dose of study drug during this open-label study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ligelizumab | QGE031 240 mg s.c. q4w x 13 treatments |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age | Mean | Standard Deviation | years |
| ||||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||||
| Sex/Gender, Customized | The Safety set (SS) included all subjects who received at least one dose of study drug during this open-label study. | Number | Percentage of Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | The Safety set (SS) included all subjects who received at least one dose of study drug during this open-label study. | Number | Percentage of 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 | Number of Participants With at Least One Treatment Emergent Adverse Event (AE) | The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest. | Safety Set: All 226 subjects who received at least one dose of study drug during this open-label study were included. | Posted | Count of Participants | Participants | Within 16 weeks after Week 48 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Having Achieved UAS7 ≤ 6 | The secondary objective of this study was to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations: Sustained remission defined as maintaining (Urticaria Activity Score) UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch. | Safety Set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 52 and Week 100 |
|
| ||||||||||||||||||||||||||
| Secondary | Number and Proportion of Participants Who Achieved UAS7≤ 6 | Summary of subjects with UAS7 ≤ 6. The long term efficacy of one-year treatment of ligelizumab 240 mg s.c. q4w is assessed by number and proportion of participants who achieved well controlled disease (UAS7≤ 6) at end of the treatment period (Week 52) and end of follow up period (Week 100). | Safety Set | Posted | Count of Participants | Participants | Baseline, Week 52, Week 100 |
|
|
Within 16 weeks after Week 48
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
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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 240 mg q4w (TEAE) | QGE031 240 mg every four weeks (TEAE) | 1 | 226 | 15 | 226 | 133 | 226 |
| EG001 | QGE031 240 mg q4w (Non-TEAE) | QGE031 240 mg every four weeks (non-TEAE) | 0 | 226 | 6 | 226 | 38 | 226 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Mouth cyst | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (22.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (22.0) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Lead | Novartis Pharmaceuticals | +1 (862) 778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2019 | Apr 28, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D014581 | Urticaria |
| ID | Term |
|---|---|
| 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 |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
Not provided
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| ID | Term |
|---|---|
| C000598891 | ligelizumab |
Not provided
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|
| Male |
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| Black or African American |
|
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| White |
|
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| American Indian or Alaska Native |
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| Unknown |
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| Other |
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