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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02040844

Enrollment

430

Registered

2014-01-20

Start date

2014-02-28

Completion date

2017-05-31

Last updated

2018-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cat Allergy

Brief summary

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.

Interventions

DRUGReceived Cat-PAD Treatment 1 in Study CP007 [NCT01620762]

DRUGReceived Cat-PAD Treatment 2 in Study CP007 [NCT01620762]

DRUGReceived Cat-PAD Treatment 3 in Study CP007 [NCT01620762]

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* previously completed clinical study CP007 \[NCT01620762\]

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])	1 year after completing CP007	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.

Secondary

Measure	Time frame	Description
Mean TRSS	1 year after completion of CP007	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).
Mean Component Scores of the TRSS (Nasal)	1 year after completion of CP007	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.
Mean Component Scores of the TRSS (Ocular)	1 year after completion of CP007	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
Mean Allergy Medication Score (AMS)	1 year after completion of CP007	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.
Mean RQLQ Score	1 year after completion of CP007	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.

Participant flow

Participants by arm

Arm	Count
Cat-PAD Treatment 1 (1 Course) Cat-PAD: 1 dose every 4 weeks followed by placebo 1 dose every 4 weeks	138
Cat-PAD Treatment (2 Courses) Cat-PAD: 1 dose every 4 weeks followed by a second course of 1 dose every 4 weeks	148
Placebo Placebo - 1 dose every 4 weeks	144
Total	430

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	0	1
Overall Study	Concomitant medication	1	3	1
Overall Study	Lost to Follow-up	12	9	13
Overall Study	Missing	13	3	2
Overall Study	Non-specified	8	2	5
Overall Study	Withdrawal by Subject	16	22	25

Baseline characteristics

Characteristic	Cat-PAD Treatment 1 (1 Course)	Cat-PAD Treatment (2 Courses)	Placebo	Total
Age, Categorical <=18 years	5 Participants	10 Participants	8 Participants	23 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	1 Participants	2 Participants
Age, Categorical Between 18 and 65 years	133 Participants	137 Participants	135 Participants	405 Participants
Race/Ethnicity, Customized American hispanic	0 Participants	1 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Asian (Indian)	0 Participants	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Asian (Oriental)	0 Participants	0 Participants	3 Participants	3 Participants
Race/Ethnicity, Customized Black	2 Participants	1 Participants	1 Participants	4 Participants
Race/Ethnicity, Customized Caucasian	135 Participants	145 Participants	139 Participants	419 Participants
Race/Ethnicity, Customized Other	1 Participants	0 Participants	0 Participants	1 Participants
Region of Enrollment Canada	39 Subjects	36 Subjects	35 Subjects	110 Subjects
Region of Enrollment Europe	68 Subjects	82 Subjects	68 Subjects	218 Subjects
Region of Enrollment United States	31 Subjects	30 Subjects	41 Subjects	102 Subjects
Sex: Female, Male Female	89 Participants	106 Participants	97 Participants	292 Participants
Sex: Female, Male Male	49 Participants	42 Participants	47 Participants	138 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 138	0 / 148	0 / 144
other Total, other adverse events	54 / 138	62 / 148	56 / 144
serious Total, serious adverse events	3 / 138	4 / 148	3 / 144

Outcome results

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.

Time frame: 1 year after completing CP007

Population: 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).

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Cat-PAD Treatment 1 (1 Course)	Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])	1.99 units on a scale	Standard Error 0.16
Cat-PAD Treatment (2 Courses)	Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])	1.91 units on a scale	Standard Error 0.15
Placebo	Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])	1.93 units on a scale	Standard Error 0.15

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.