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Safety of Cat-PAD in Cat Allergic Subjects

Primary Purpose

Cat Allergy

Status

Completed

Phase

Phase 1

Locations

Germany

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

Eligibility Criteria

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

Inclusion Criteria:

A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year.
Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response on single arm.

Exclusion Criteria:

Subjects with asthma falling under GINA(2006) 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 normal.
Subjects with an acute phase skin response to cat allergen with a weal diameter > 30mm.
Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season.
Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever.
Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria.
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

Sites / Locations

Allergy-Centre-Charité

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Arm Description

Placebo intradermal n = 2 with each dose level of Cat-PAD.

Intradermal injection of increasing single doses of Cat-PAD (0.03, 0.3, 3, 12 nmol) n = 6 per dose level. Based on review of blinded LPSR, an additional dose of Cat-PAD between 0.03 and 12 nmol may be administered to an additional cohort of 6 subjects.

Placebo subcutaneous n = 2 with each dose level of Cat-PAD.

Subcutaneous injection of increasing single doses of Cat-PAD (0.03, 0.3, 3, 12, 20 nmol) n = 6 per dose level. Based on review of blinded LPSR, an additional dose of Cat-PAD between 0.03 and 20 nmol may be administered to an additional cohort of 6 subjects.

Outcomes

Primary Outcome Measures

Safety and tolerability of Cat-PAD

Secondary Outcome Measures

Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen.

Full Information

NCT ID

NCT00685711

First Posted

May 20, 2008

Last Updated

August 5, 2008

Sponsor

Circassia Limited

1. Study Identification

Unique Protocol Identification Number

NCT00685711

Brief Title

Safety of Cat-PAD in Cat Allergic Subjects

Official Title

An Escalating Single Intradermal or Subcutaneous Dose Study in Cat Allergic Subjects to Assess the Safety of Cat-PAD.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Circassia Limited

4. Oversight

Data Monitoring Committee

Yes

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 safety of Cat-PAD administered as increasing single doses.

Detailed Description

This study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. Cohorts of 8 subjects will be enrolled. Each cohort will undergo screening 14-28 days before treatment and a baseline challenge for EPSR and LPSR to cat allergen injected into the arm 7 days before treatment. On the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of Cat-PAD or placebo and safety observations made for 8 h. After 21 days, subjects will again have cat allergen injected into the arm and the EPSR and LPSR will be recorded. The dose of Cat-PAD will be increased in successive cohorts, provided that the previous dose tested was well tolerated.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo intradermal n = 2 with each dose level of Cat-PAD.

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo subcutaneous n = 2 with each dose level of Cat-PAD.

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Cat-PAD

Intervention Description

single, escalating dose intradermal and subcutaneous injections of Cat-PAD

Primary Outcome Measure Information:

Title

Safety and tolerability of Cat-PAD

Time Frame

0, 7, 21 days

Secondary Outcome Measure Information:

Title

Late-Phase Skin Reaction (LPSR) 8 hours after intradermal challenge with whole cat allergen.

Time Frame

Day 21

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: A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (GINA (2006) classification 1) on exposure to cats for at least 1 year. Late-Phase Allergic Skin Reaction (LPSR) to 0.010 HEP units Leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response on single arm. Exclusion Criteria: Subjects with asthma falling under GINA(2006) 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 normal. Subjects with an acute phase skin response to cat allergen with a weal diameter > 30mm. Subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season. Allergen immunotherapy during the last 5 years or Cat Dander immunotherapy ever. Use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). If it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margitta Worm, MD Professor

Organizational Affiliation

Allergy-Centre-Charité

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allergy-Centre-Charité

City

Berlin

ZIP/Postal Code

D-10117

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Safety of Cat-PAD in Cat Allergic Subjects

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