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Clinical Trial Results:
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

Summary
EudraCT number	2013-004669-15
Trial protocol	BE DE CZ
Global end of trial date	31 May 2017

Results information
Results version number	v1(current)
This version publication date	14 Apr 2018
First version publication date	14 Apr 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CP007A

ISRCTN number

US NCT number

NCT02040844

WHO universal trial number (UTN)

Sponsor organisation name

Circassia Limited

Sponsor organisation address

Robert Robinson Avenue, Oxford, United Kingdom,

Public contact

CP007A-ClinicalTrialInformationDesk, Circassia Limited, +44 1865598078, CP007AClinicalTrialInformationDesk@circassia.co.uk

Scientific contact

CP007A-ClinicalTrialInformationDesk, Circassia Limited, +44 1865598078, CP007AClinicalTrialInformationDesk@circassia.co.uk

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001054-PIP10-03

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

27 Jul 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

31 May 2017

Global end of trial reached?

Yes

Global end of trial date

31 May 2017

Was the trial ended prematurely?

Main objective of the trial

To evaluate the continued efficacy of Cat-PAD, the first in a new class of Synthetic Peptide Immuno-Regulatory Epitopes, for a total of up to five years after the administration of treatment, based on the reduction of symptoms and the use of allergy medication in subjects previously participating in CP007.

Protection of trial subjects

None

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Apr 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 115

Country: Number of subjects enrolled

Belgium: 8

Country: Number of subjects enrolled

Czech Republic: 85

Country: Number of subjects enrolled

Germany: 17

Country: Number of subjects enrolled

Canada: 101

Country: Number of subjects enrolled

United States: 104

Worldwide total number of subjects

430

EEA total number of subjects

225

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

405

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Subjects who successfully completed CP007 were eligible for CP007A

Period 1 title

Randomisation (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Treatment Group 1

Arm description

single course of Cat-PAD 4x6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart

Arm type

Experimental

Investigational medicinal product name

Cat-PAD

Investigational medicinal product code

Cat-PAD

Other name

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Intradermal use

Dosage and administration details

A single course of Cat-PAD 4x6 nmol 4 weeks apart followed by 4x placebo 4 weeks apart

Investigational medicinal product name

Cat-PAD

Investigational medicinal product code

Cat-PAD

Other name

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Intradermal use

Dosage and administration details

Single course of Cat-PAD 4x6 nmol 4 weeks apart followed by a second course of Cat-PAD 4x6 nmol 4 weeks apart

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Intradermal use

Dosage and administration details

Two courses of 4 x placebo 4 weeks apart

Investigational medicinal product name

Cat-PAD

Investigational medicinal product code

Cat-PAD

Other name

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Intradermal use

Dosage and administration details

A single course of Cat-PAD 4x6 nmol 4 weeks apart followed by 4x placebo 4 weeks apart

Treatment Group 2

Arm description

single course of Cat-PAD 4x6 nmol 4 weeks apart followed by a second course of Cat-PAD 4x6 nmol 4 weeks apart

Arm type

Experimental

Investigational medicinal product name

Cat-PAD

Investigational medicinal product code

Cat-PAD

Other name

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Intradermal use

Dosage and administration details

Single course of Cat-PAD 4x6 nmol 4 weeks apart followed by a second course of Cat-PAD 4x6 nmol 4 weeks apart

Treatment Group 3

Arm description

Two courses of 4 x placebo 4 weeks apart

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Intradermal use

Dosage and administration details

Two courses of 4 x placebo 4 weeks apart

Number of subjects in period 1	Treatment Group 1	Treatment Group 2	Treatment Group 3
Started	138	148	144
Completed	88	109	97
Not completed	50	39	47
Consent withdrawn by subject	16	22	25
Adverse event, non-fatal	-	-	1
Not specified	8	2	5
Concomittant medication	1	3	1
Lost to follow-up	12	9	13
Missing	13	3	2

Baseline characteristics

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Reporting group title

Randomisation

Reporting group description

Reporting group values	Randomisation	Total
Number of subjects	430	430
Age categorical
Units: Subjects
Adolescents (12-17 years)	23	23
Adults (18-64 years)	405	405
From 65-84 years	2	2
Gender categorical
Units: Subjects
Female	292	292
Male	138	138

End points

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Reporting group title

Treatment Group 1

Reporting group description

single course of Cat-PAD 4x6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart

Reporting group title

Treatment Group 2

Reporting group description

single course of Cat-PAD 4x6 nmol 4 weeks apart followed by a second course of Cat-PAD 4x6 nmol 4 weeks apart

Reporting group title

Treatment Group 3

Reporting group description

Two courses of 4 x placebo 4 weeks apart

Primary: Mean Combined Score (CS) consisting of (TRSS/8 + Allergy Medication Score [AMS])

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End point title

Mean Combined Score (CS) consisting of (TRSS/8 + Allergy Medication Score [AMS]) ^[1]

End point description

End point type

Primary

End point timeframe

The first analysis of the data will be performed on the first year's data after all subjects have completed one year in this study.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The primary reporting value was least squares mean

End point values	Treatment Group 1	Treatment Group 2	Treatment Group 3
Number of subjects analysed	88	109	97
Units: CS
least squares mean (standard error)	1.99 ( 0.16 )	1.91 ( 0.15 )	1.93 ( 0.15 )

No statistical analyses for this end point

Secondary: Mean TRSS

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End point title

Mean TRSS

End point description

End point type

Secondary

End point timeframe

The first analysis of the data will be performed on the first year's data after all subjects have completed one year in this study

End point values	Treatment Group 1	Treatment Group 2	Treatment Group 3
Number of subjects analysed	88	109	97
Units: TRSS
least squares mean (standard error)	12.95 ( 0.69 )	13.15 ( 0.66 )	12.92 ( 0.67 )

No statistical analyses for this end point

Secondary: Mean component scores of the TRSS (nasal)

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End point title

Mean component scores of the TRSS (nasal)

End point description

End point type

Secondary

End point timeframe

The first analysis of the data will be performed on the first year's data after all subjects have completed one year in this study.

End point values	Treatment Group 1	Treatment Group 2	Treatment Group 3
Number of subjects analysed	88	109	97
Units: TNSS
least squares mean (standard error)	7.06 ( 0.39 )	7.17 ( 0.37 )	6.96 ( 0.38 )

No statistical analyses for this end point

Secondary: Mean component scores of the TRSS (ocular)

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End point title

Mean component scores of the TRSS (ocular)

End point description

End point type

Secondary

End point timeframe

The first analysis of the data will be performed on the first year's data after all subjects have completed one year in this study

End point values	Treatment Group 1	Treatment Group 2	Treatment Group 3
Number of subjects analysed	88	109	97
Units: TOSS
least squares mean (standard error)	5.90 ( 0.35 )	5.97 ( 0.33 )	6.00 ( 0.34 )

No statistical analyses for this end point

Secondary: Mean Allergy Medication Score (AMS)

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End point title

Mean Allergy Medication Score (AMS)

End point description

End point type

Secondary

End point timeframe

The first analysis of the data will be performed on the first year's data after all subjects have completed one year in this study.

End point values	Treatment Group 1	Treatment Group 2	Treatment Group 3
Number of subjects analysed	88	109	97
Units: RMS
least squares mean (standard error)	0.37 ( 0.09 )	0.27 ( 0.09 )	0.31 ( 0.09 )

No statistical analyses for this end point

Secondary: Mean RQLQ Score

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End point title

Mean RQLQ Score

End point description

End point type

Secondary

End point timeframe

The first analysis of the data will be performed on the first year's data after all subjects have completed one year in this study.

End point values	Treatment Group 1	Treatment Group 2	Treatment Group 3
Number of subjects analysed	88	109	97
Units: RQLQ
least squares mean (standard error)	1.58 ( 0.22 )	1.62 ( 0.21 )	1.51 ( 0.22 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

The first analysis of the data will be performed on the first year's data after all subjects have completed one year in this study.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Treatment Group 1

Reporting group description

single course of Cat-PAD 4x6 nmol 4 weeks apart followed by 4 x placebo 4 weeks apart

Reporting group title

Treatment Group 2

Reporting group description

single course of Cat-PAD 4x6 nmol 4 weeks apart followed by a second course of Cat-PAD 4x6 nmol 4 weeks apart

Reporting group title

Treatment Group 3

Reporting group description

Two courses of 4 x placebo 4 weeks apart

Serious adverse events	Treatment Group 1	Treatment Group 2	Treatment Group 3
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 138 (2.17%)	4 / 148 (2.70%)	4 / 144 (2.78%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
subjects affected / exposed	1 / 138 (0.72%)	0 / 148 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	0 / 138 (0.00%)	1 / 148 (0.68%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Radius fracture
subjects affected / exposed	0 / 138 (0.00%)	0 / 148 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
subjects affected / exposed	0 / 138 (0.00%)	1 / 148 (0.68%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
subjects affected / exposed	1 / 138 (0.72%)	0 / 148 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 138 (0.00%)	0 / 148 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colonic fistula
subjects affected / exposed	1 / 138 (0.72%)	0 / 148 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	1 / 138 (0.72%)	0 / 148 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Uterine polyp
subjects affected / exposed	0 / 138 (0.00%)	0 / 148 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	0 / 138 (0.00%)	1 / 148 (0.68%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 138 (0.00%)	0 / 148 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Colonic abscess
subjects affected / exposed	1 / 138 (0.72%)	0 / 148 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis Escherichia coli
subjects affected / exposed	1 / 138 (0.72%)	0 / 148 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 138 (0.00%)	1 / 148 (0.68%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Treatment Group 1	Treatment Group 2	Treatment Group 3
Total subjects affected by non serious adverse events
subjects affected / exposed	54 / 138 (39.13%)	62 / 148 (41.89%)	56 / 144 (38.89%)
Nervous system disorders
Headache
subjects affected / exposed	5 / 138 (3.62%)	6 / 148 (4.05%)	6 / 144 (4.17%)
occurrences all number	21	6	7
Migraine
subjects affected / exposed	1 / 138 (0.72%)	1 / 148 (0.68%)	6 / 144 (4.17%)
occurrences all number	1	2	7
Gastrointestinal disorders
Nausea
subjects affected / exposed	1 / 138 (0.72%)	4 / 148 (2.70%)	3 / 144 (2.08%)
occurrences all number	1	4	5
Abdominal pain
subjects affected / exposed	1 / 138 (0.72%)	1 / 148 (0.68%)	3 / 144 (2.08%)
occurrences all number	2	1	3
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	5 / 138 (3.62%)	2 / 148 (1.35%)	5 / 144 (3.47%)
occurrences all number	6	2	5
Asthma
subjects affected / exposed	2 / 138 (1.45%)	3 / 148 (2.03%)	6 / 144 (4.17%)
occurrences all number	2	3	6
Oropharyngeal pain
subjects affected / exposed	1 / 138 (0.72%)	4 / 148 (2.70%)	3 / 144 (2.08%)
occurrences all number	1	4	4
Nasal congestion
subjects affected / exposed	2 / 138 (1.45%)	0 / 148 (0.00%)	3 / 144 (2.08%)
occurrences all number	2	0	4
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
subjects affected / exposed	0 / 138 (0.00%)	1 / 148 (0.68%)	3 / 144 (2.08%)
occurrences all number	0	1	3
Infections and infestations
Nasopharyngitis
subjects affected / exposed	15 / 138 (10.87%)	20 / 148 (13.51%)	18 / 144 (12.50%)
occurrences all number	19	30	36
Sinusitis
subjects affected / exposed	6 / 138 (4.35%)	6 / 148 (4.05%)	5 / 144 (3.47%)
occurrences all number	6	9	7
Influenza
subjects affected / exposed	5 / 138 (3.62%)	4 / 148 (2.70%)	7 / 144 (4.86%)
occurrences all number	8	4	11
Upper respiratory tract infection
subjects affected / exposed	2 / 138 (1.45%)	2 / 148 (1.35%)	8 / 144 (5.56%)
occurrences all number	4	2	10
Bronchitis
subjects affected / exposed	4 / 138 (2.90%)	4 / 148 (2.70%)	2 / 144 (1.39%)
occurrences all number	4	4	2
Tonsillitis
subjects affected / exposed	3 / 138 (2.17%)	3 / 148 (2.03%)	2 / 144 (1.39%)
occurrences all number	3	4	2
Pharyngitis
subjects affected / exposed	1 / 138 (0.72%)	4 / 148 (2.70%)	1 / 144 (0.69%)
occurrences all number	1	5	1
Conjunctivitis
subjects affected / exposed	3 / 138 (2.17%)	1 / 148 (0.68%)	1 / 144 (0.69%)
occurrences all number	3	1	1
Gastroenteritis viral
subjects affected / exposed	0 / 138 (0.00%)	0 / 148 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	3
Viral upper respiratory tract infection
subjects affected / exposed	0 / 138 (0.00%)	0 / 148 (0.00%)	3 / 144 (2.08%)
occurrences all number	0	0	6

More information

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Were there any global substantial amendments to the protocol? Yes

16 Jan 2015

Protocol version 5.0. Introduction of more frequent study visits

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean Combined Score (CS) consisting of (TRSS/8 + Allergy Medication Score [AMS])

Primary: Mean Combined Score (CS) consisting of (TRSS/8 + Allergy Medication Score [AMS])

Secondary: Mean TRSS

Secondary: Mean TRSS

Secondary: Mean component scores of the TRSS (nasal)

Secondary: Mean component scores of the TRSS (nasal)

Secondary: Mean component scores of the TRSS (ocular)

Secondary: Mean component scores of the TRSS (ocular)

Secondary: Mean Allergy Medication Score (AMS)

Secondary: Mean Allergy Medication Score (AMS)

Secondary: Mean RQLQ Score

Secondary: Mean RQLQ Score

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
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Hungary
Iceland
Ireland
Italy
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Outside EU/EEA

Clinical trials

Clinical Trial Results: 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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean Combined Score (CS) consisting of (TRSS/8 + Allergy Medication Score [AMS])

Primary: Mean Combined Score (CS) consisting of (TRSS/8 + Allergy Medication Score [AMS])

Secondary: Mean TRSS

Secondary: Mean TRSS

Secondary: Mean component scores of the TRSS (nasal)

Secondary: Mean component scores of the TRSS (nasal)

Secondary: Mean component scores of the TRSS (ocular)

Secondary: Mean component scores of the TRSS (ocular)

Secondary: Mean Allergy Medication Score (AMS)

Secondary: Mean Allergy Medication Score (AMS)

Secondary: Mean RQLQ Score

Secondary: Mean RQLQ Score

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
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