Phase III Cat-PAD Study

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

Conditions
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Rhinoconjunctivitis

Intervention / Treatment
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* Drug: Cat-PAD
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female, aged 12-65 years. Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years. Subjects may optionally also have GINA Step 1 controlled asthma. Positive skin prick test to cat hair. Cat dander specific IgE ≥0.35 kU/L. Exclusion Criteria Asthma falling under the GINA definitions partly controlled and uncontrolled or Steps 2 to 5. FEV1 <80% of predicted. Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period. Skin prick test 5 mm greater than the negative control to perennial allergens or animal dander (other than cat) which cannot be avoided during the study. Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms. Clinically relevant abnormalities detected on physical examination. History of severe drug allergy, severe angioedema or anaphylactic reaction to food.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cat-Pad Treatment 1<br>Cat-PAD Treatment 1 | Drug: Cat-PAD<br>* 1 dose every 4 weeks<br>|
| Experimental: Cat-PAD Treatment 2<br>Cat-PAD Treatment regimen 2 | Drug: Cat-PAD<br>* 1 dose every 4 weeks<br>Drug: Placebo<br>* 1 dose every 4 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 1 dose every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 52-54 weeks after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cat allergy, Rhinoconjunctivitis