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Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects

Primary Purpose

Cat Allergy

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Cat-PAD

About this trial

This is an interventional treatment trial for Cat Allergy focused on measuring Cat allergy, Immunotherapy, Cat-PAD, Environmental Exposure Chamber

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Minimum 1-year documented history of rhinoconjunctivitis (Nasal symptoms: sneezing, itching, rhinorrhoea, blockage; Ocular symptoms: itching, redness, soreness, watering) on exposure to cats. [Subjects may also have controlled asthma (GINA classification 1)].
Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
Subjects must achieve minimum qualifying symptom scores on at least one Symptom Diary Card during EEC exposure on the third and fourth day during the Baseline Challenge. Minimum qualifying symptom scores are defined as a TRSS of at least 10 out of a possible 24 and a TNSS of at least 6 out of a possible 12.

Exclusion Criteria:

Subjects with asthma falling under GINA classification 2 (partly controlled) and 3 (uncontrolled).
A history of anaphylaxis to cat allergen.
Subjects with a cat specific IgE >100 kU/L.
Subjects with an FEV1 <80% of predicted.
Subjects with an acute phase skin response to cat allergen with a mean wheal diameter > 50mm.
Subjects who suffer from seasonal allergic rhinoconjunctivitis, and cannot complete the clinical study outside the local pollen season or who have significant allergy to other animal dander that cannot be avoided during the study period.
Subjects who cannot tolerate baseline challenge in the EEC.
Allergen immunotherapy during the last 12 months or any history of Cat Dander immunotherapy.
Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
Subjects being treated with beta-blockers.
History of immunopathological diseases.
Positive test for Hepatitis B, Hepatitis C or HIV at screening.
Have a history of severe drug allergy or anaphylactic reaction to food.
A known allergy to thioglycerol.

Sites / Locations

Cetero Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Total Rhinoconjunctivitis Symptom Score (TRSS) using all timepoints during PTC in Cat-PAD treatment groups compared to placebo.

Secondary Outcome Measures

Change from baseline in TRSS in Cat-PAD treatment groups at last two timepoints on third and fourth challenge days compared to placebo.

Change from baseline in individual symptom scores for ocular and nasal symptoms at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo.

Change from baseline in TRSS at all timepoints during Exposure Chamber visit in pooled data from Cat-PAD treatment groups compared to placebo.

Proportion of subjects prematurely leaving the EEC due to intolerable symptoms during Post-Treatment Challenge (PTC) in Cat-PAD treatment groups compared to placebo.

Change from baseline in EEC-Rhinoconjunctivitis Quality of Life Questionnaire (EEC-RQOL) at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo.

Exploratory analyses of change from baseline in asthma symptoms, FEV1 and use of rescue medication in Cat-PAD treatment groups compared to placebo in asthmatic subjects.

Full Information

NCT ID

NCT00729508

First Posted

August 4, 2008

Last Updated

July 7, 2009

Sponsor

Circassia Limited

1. Study Identification

Unique Protocol Identification Number

NCT00729508

Brief Title

Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects

Official Title

A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate the Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Circassia Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will investigate the efficacy of 4 treatment regimens of Cat-PAD in cat allergic subjects following challenge to cat allergen in an environmental exposure chamber (EEC).

Detailed Description

This study is designed as a multicentre, randomised, double-blind, placebo-controlled study of 4 treatment regimens in up to 120 cat allergic subjects. A total of 24 subjects will be randomised into each treatment group. Each subject will undergo screening up to 4 weeks before treatment. Baseline challenge will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days a week before the first administration of Cat-PAD or placebo. Treatment will be administered as intradermal injections into the flexor surface of alternate forearms. There are 5 treatment regimens involving administration of Cat-PAD or placebo. Post-treatment challenge (PTC) will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days 18 weeks after the first administration of study medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cat Allergy

Keywords

Cat allergy, Immunotherapy, Cat-PAD, Environmental Exposure Chamber

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Cat-PAD

Intervention Description

Cat-PAD dose 2X 4 administrations 2 weeks apart

Intervention Type

Biological

Intervention Name(s)

Cat-PAD

Intervention Description

Cat-PAD dose 1X 4 administrations 2 weeks apart

Intervention Type

Biological

Intervention Name(s)

Cat-PAD

Intervention Description

Cat-PAD dose 1X 4 administrations 4 weeks apart

Intervention Type

Biological

Intervention Name(s)

Cat-PAD

Intervention Description

Cat-PAD dose 1X 8 administrations 2 weeks apart

Intervention Type

Biological

Intervention Name(s)

Cat-PAD

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change from baseline in Total Rhinoconjunctivitis Symptom Score (TRSS) using all timepoints during PTC in Cat-PAD treatment groups compared to placebo.

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in TRSS in Cat-PAD treatment groups at last two timepoints on third and fourth challenge days compared to placebo.

Time Frame

18 weeks

Title

Change from baseline in individual symptom scores for ocular and nasal symptoms at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo.

Time Frame

18 weeks

Title

Change from baseline in TRSS at all timepoints during Exposure Chamber visit in pooled data from Cat-PAD treatment groups compared to placebo.

Time Frame

18 weeks

Title

Proportion of subjects prematurely leaving the EEC due to intolerable symptoms during Post-Treatment Challenge (PTC) in Cat-PAD treatment groups compared to placebo.

Time Frame

18 weeks

Title

Change from baseline in EEC-Rhinoconjunctivitis Quality of Life Questionnaire (EEC-RQOL) at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo.

Time Frame

18 weeks

Title

Exploratory analyses of change from baseline in asthma symptoms, FEV1 and use of rescue medication in Cat-PAD treatment groups compared to placebo in asthmatic subjects.

Time Frame

18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Minimum 1-year documented history of rhinoconjunctivitis (Nasal symptoms: sneezing, itching, rhinorrhoea, blockage; Ocular symptoms: itching, redness, soreness, watering) on exposure to cats. [Subjects may also have controlled asthma (GINA classification 1)]. Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control. Subjects must achieve minimum qualifying symptom scores on at least one Symptom Diary Card during EEC exposure on the third and fourth day during the Baseline Challenge. Minimum qualifying symptom scores are defined as a TRSS of at least 10 out of a possible 24 and a TNSS of at least 6 out of a possible 12. Exclusion Criteria: Subjects with asthma falling under GINA classification 2 (partly controlled) and 3 (uncontrolled). A history of anaphylaxis to cat allergen. Subjects with a cat specific IgE >100 kU/L. Subjects with an FEV1 <80% of predicted. Subjects with an acute phase skin response to cat allergen with a mean wheal diameter > 50mm. Subjects who suffer from seasonal allergic rhinoconjunctivitis, and cannot complete the clinical study outside the local pollen season or who have significant allergy to other animal dander that cannot be avoided during the study period. Subjects who cannot tolerate baseline challenge in the EEC. Allergen immunotherapy during the last 12 months or any history of Cat Dander immunotherapy. Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). Subjects being treated with beta-blockers. History of immunopathological diseases. Positive test for Hepatitis B, Hepatitis C or HIV at screening. Have a history of severe drug allergy or anaphylactic reaction to food. A known allergy to thioglycerol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deepen Patel, MD

Organizational Affiliation

Allied Research International Inc-Cetero Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cetero Research

City

Toronto

State/Province

Ontario

ZIP/Postal Code

L4W 1N2

Country

Canada

12. IPD Sharing Statement

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Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects

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