Phase III Cat-PAD Follow-on Study

An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years After the Administration of Treatment

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.

Study Overview

• Status: Completed
• Conditions: Cat Allergy
• Intervention / Treatment: Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]; Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]; Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• previously completed clinical study CP007 [NCT01620762]

Exclusion Criteria:

• started allergen therapy since completing CP007
• Institutionalised due to a legal or regulatory order

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cat-PAD Treatment 1; Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762].No further treatment received in CP007A	Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]
Other: Cat-PAD Treatment 2; Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762].No further treatment received in CP007A.	Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]
Other: Cat-PAD Treatment 3; Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]. No further treatment received in CP007A.	Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Circassia Limited
• Investigators: Principal Investigator: Jörg Kleine-Tebbe, MD, Clinical Research Center for Dermatology, Allergy & Asthma

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CP007 A