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The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cat-PAD Treatment 1 | Other | Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762].No further treatment received in CP007A |
|
| Cat-PAD Treatment 2 | Other | Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762].No further treatment received in CP007A. |
|
| Cat-PAD Treatment 3 | Other | Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]. No further treatment received in CP007A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762] | Drug |
| ||
| Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762] |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS]) | The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007). CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). 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 TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3. AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6. | 1 year after completing CP007 |
| 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 one year after completing the first study (CP007). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jörg Kleine-Tebbe, MD | Clinical Research Center for Dermatology, Allergy & Asthma | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cat-PAD Treatment 1 (1 Course) | Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks |
| FG001 | Cat-PAD Treatment (2 Courses) | Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks |
| FG002 | Placebo | Placebo - 1 dose every 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cat-PAD Treatment 1 (1 Course) | Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks |
| BG001 | Cat-PAD Treatment (2 Courses) | Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks |
| 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 |
| 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 (CS) Consisting of TRSS/8+Allergy Medication Score[AMS]) | The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007). CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). 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 TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3. AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6. | The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment). | Posted | Least Squares Mean | Standard Error | units on a scale | 1 year after completing CP007 |
Adverse event data was collected throughout the whole study period from the point of enrolment to the completion of outcome data which was timed to occur 2 year after the completion of the original CP007 study
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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 | Cat-PAD Treatment 1 (1 Course) | Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Operations | Circassia Ltd | +44 1865 405560 | info@circassia.com |
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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 | Dec 8, 2014 | Mar 29, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2017 | Mar 29, 2018 | SAP_001.pdf |
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| Drug |
|
| Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762] | Drug |
|
| 1 year after completion of CP007 |
| Mean Component Scores of the TRSS (Nasal) | 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 1 year after completing the original CP007 study. | 1 year after completion of CP007 |
| Mean Component Scores of the TRSS (Ocular) | Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups 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. 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 one year after completing the original CP007 study | 1 year after completion of CP007 |
| Mean Allergy Medication Score (AMS) | Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use 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. | 1 year after completion of CP007 |
| Mean RQLQ Score | The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007). 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. A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome. | 1 year after completion of CP007 |
| Lost to Follow-up |
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| Missing |
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| Non-specified |
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| Concomitant medication |
|
| BG002 | Placebo | Placebo - 1 dose every 4 weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | Subjects |
|
| ID | Title | Description |
|---|
| OG000 | Cat-PAD Treatment 1 (1 Course) | Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks |
| OG001 | Cat-PAD Treatment (2 Courses) | Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks |
| OG002 | Placebo | Placebo - 1 dose every 4 weeks |
|
|
| 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 one year after completing the first study (CP007). | The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment). | Posted | Least Squares Mean | Standard Error | units on a scale | 1 year after completion of CP007 |
|
|
|
| Secondary | Mean Component Scores of the TRSS (Nasal) | 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 1 year after completing the original CP007 study. | The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment). | Posted | Least Squares Mean | Standard Error | units on a scale | 1 year after completion of CP007 |
|
|
|
| Secondary | Mean Component Scores of the TRSS (Ocular) | Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups 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. 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 one year after completing the original CP007 study | The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment). | Posted | Least Squares Mean | Standard Error | units on a scale | 1 year after completion of CP007 |
|
|
|
| Secondary | Mean Allergy Medication Score (AMS) | Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups. The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use 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. | The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment). | Posted | Least Squares Mean | Standard Error | units on a scale | 1 year after completion of CP007 |
|
|
|
| Secondary | Mean RQLQ Score | The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007). 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. A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome. | The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment). | Posted | Least Squares Mean | Standard Error | units on a scale | 1 year after completion of CP007 |
|
|
|
| 0 |
| 138 |
| 3 |
| 138 |
| 54 |
| 138 |
| EG001 | Cat-PAD Treatment (2 Courses) | Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks | 0 | 148 | 4 | 148 | 62 | 148 |
| EG002 | Placebo | Placebo - 1 dose every 4 weeks | 0 | 144 | 3 | 144 | 56 | 144 |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Anapylactic reaction | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
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| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
|
| Colonic fistula | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Uterine polyp | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Colonic abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Gastronteritis Escheria coli | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | 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.