Not provided
Not provided
Not provided
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Not provided
Not provided
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| Name | Class |
|---|---|
| inVentiv Health Clinical | OTHER |
| Pharm-Olam International | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the treatment effect of two treatment regimens of Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue medication usage and Quality of Life.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cat-Pad Treatment 1 | Experimental | Cat-PAD Treatment 1 |
|
| Cat-PAD Treatment 2 | Experimental | Cat-PAD Treatment regimen 2 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cat-PAD | Drug | 1 dose every 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo | The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3. RMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6. | 52-54 weeks after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean TRSS | Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo. Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harold Nelson, MD | Jewish National Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rolling Hills Estates | California | United States | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cat-PAD Treatment 1 (1 Course) | Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks |
| FG001 | Cat-PAD Treatment 2 (2 Courses) | Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
1 dose every 4 weeks |
|
| 52-54 weeks after randomisation |
| Mean Daily TNSS in Cat-PAD Compared With Placebo | TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. | 52-54 weeks after randomisation |
| Mean Daily TOSS in Cat-PAD Compared to Placebo | Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. | 52-54 weeks after randomisation |
| Mean RMS in Cat-PAD Compared With Placebo | Mean RMS (Rescue medication score) in Cat-PAD treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 52-54 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive. | 52-54 weeks after randomisation |
| Mean RQLQ Score in Cat-PAD Compared With Placebo | The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (52-54 weeks after randomisation). The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six. | 52-54 weeks after randomisation |
| Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use | The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 52-54 weeks after randomisation. | 52-54 week after randomisaiton |
| Colorado Springs |
| Colorado |
| United States |
| Denver | Colorado | United States |
| Wheat Ridge | Colorado | United States |
| Eagle | Idaho | United States |
| Meridian | Idaho | United States |
| Chicago | Illinois | United States |
| Evanston | Illinois | United States |
| Forrest | Illinois | United States |
| Normal | Illinois | United States |
| Iowa City | Iowa | United States |
| Overland Park | Kansas | United States |
| Bangor | Maine | United States |
| Brockton | Massachusetts | United States |
| Ypsilanti | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Bozeman | Montana | United States |
| Missoula | Montana | United States |
| Bellevue | Nebraska | United States |
| Fremont | Nebraska | United States |
| Omaha | Nebraska | United States |
| Ocean Township | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Corning | New York | United States |
| Newburgh | New York | United States |
| Fargo | North Dakota | United States |
| Minot | North Dakota | United States |
| Canton | Ohio | United States |
| Cincinnati | Ohio | United States |
| Middleburg Heights | Ohio | United States |
| Sylvania | Ohio | United States |
| Toledo | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Lake Oswego | Oregon | United States |
| Medford | Oregon | United States |
| Portland | Oregon | United States |
| Blue Bell | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Draper | Utah | United States |
| Glen Allen | Virginia | United States |
| South Burlington | Virginia | United States |
| Warrenton | Virginia | United States |
| Spokane | Washington | United States |
| Greenfield | Wisconsin | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Brussels | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Burlington | Ontario | Canada |
| Corruna | Ontario | Canada |
| Hamilton | Ontario | Canada |
| Kanata | Ontario | Canada |
| London | Ontario | Canada |
| Newmarket | Ontario | Canada |
| Niagara Falls | Ontario | Canada |
| Oshawa | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Pointe-Claire | Quebec | Canada |
| Québec | Quebec | Canada |
| Trois-Rivières | Quebec | Canada |
| Brnho | Czechia |
| Čáslav | Czechia |
| České Budějovice | Czechia |
| Jablonec nad Nisou | Czechia |
| Kutná Hora | Czechia |
| Prague | Czechia |
| Rychnov nad Kněžnou | Czechia |
| Berlin | Germany |
| Bonn | Germany |
| Bramsche | Germany |
| Cologne | Germany |
| Hamburg | Germany |
| Heidelberg | Germany |
| Mönchengladbach | Germany |
| München | Germany |
| Münster | Germany |
| Neuss | Germany |
| Osnabrück | Germany |
| Wesel | Germany |
| Wiesbaden | Germany |
| Wuppertal | Germany |
| Budapest | Hungary |
| Csorna | Hungary |
| Pécs | Hungary |
| Tatabánya | Hungary |
| Bydgoszcz | Poland |
| Gdansk | Poland |
| Katowice | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Poznan | Poland |
| Rzeszów | Poland |
| Tarnów | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Zabrze | Poland |
| Zawadzkie | Poland |
| Barnaul | Russia |
| Moscow | Russia |
| Novosibirsk | Russia |
| Omsk | Russia |
| Saint Petersburg | Russia |
| Stavropol | Russia |
| Tomsk | Russia |
| Yekaterinburg | Russia |
| Bardejov | Slovakia |
| Martin | Slovakia |
| Poprad | Slovakia |
| FG002 | Placebo | Placebo Placebo: 1 dose every 4 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cat-PAD Treatment 1 (1 Course) | Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks |
| BG001 | Cat-PAD Treatment 2 (2 Courses) | Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks |
| BG002 | Placebo | Placebo Placebo: 1 dose every 4 weeks |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 Combined Score in Cat-PAD Treatment Groups Compared With Placebo | The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3. RMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6. | Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | 52-54 weeks after randomisation |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean TRSS | Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo. Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. | Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | 52-54 weeks after randomisation |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Daily TNSS in Cat-PAD Compared With Placebo | TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. | Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | 52-54 weeks after randomisation |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Daily TOSS in Cat-PAD Compared to Placebo | Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms. Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation. | Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | 52-54 weeks after randomisation |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean RMS in Cat-PAD Compared With Placebo | Mean RMS (Rescue medication score) in Cat-PAD treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 52-54 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive. | Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | 52-54 weeks after randomisation |
| |||||||||||||||||||||||||||||||||
| Secondary | Mean RQLQ Score in Cat-PAD Compared With Placebo | The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (52-54 weeks after randomisation). The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six. | Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | 52-54 weeks after randomisation |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use | The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 52-54 weeks after randomisation. | Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis. | Posted | Least Squares Mean | Standard Error | days | 52-54 week after randomisaiton |
|
|
Up to 52 weeks after randomisation
The number of participants at risk for AEs and SAEs is for the safety population, one participant withdrew after randomisation but before receiving any treatment and is therefore included in the ITT population and therefore in the participant flow module but is not included in the safety population. The data presented reflects the data in the TLFs and as written in the Clinical Study Report.
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 | Cat-PAD Treatment 1 (1 Course) | Cat-PAD Treatment 1 Cat-PAD: 1 dose every 4 weeks Placebo: 1 dose every 4 weeks | 11 | 467 | 298 | 467 | ||
| EG001 | Cat-PAD Treatment 2 (2 Courses) | Cat-PAD Treatment regimen 2 Cat-PAD: 1 dose every 4 weeks | 13 | 470 | 299 | 470 | ||
| EG002 | Placebo | Placebo Placebo: 1 dose every 4 weeks | 9 | 470 | 305 | 470 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vascular headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hydonephrosis | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| IgA nephropathy | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Femoroacetabular impingement | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypthyroidism | Endocrine disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy to animal | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Orophayngeal pai | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Athma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Injection site urticaria | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
To avoid disclosures that may affect the proprietary rights of the Sponsor, the Investigator agrees to allow Circassia the opportunity to review all manuscripts and abstracts 60 days prior to submission for publication. Circassia reserves the right to include the report of this study in any regulatory documentation or submission or in any informational materials.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Operations | Circassia Ltd | +44 1865 405560 |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Placebo
Placebo: 1 dose every 4 weeks
|
|
Placebo
Placebo: 1 dose every 4 weeks
|
|
|
|