Safety of Cat-PAD in Cat Allergic Subjects

NCT00685711 | Completed Phase 1 DMC

• 1 other identifier: CP001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Cat Allergy

Keywords

Cat allergy; Immunotherapy; Cat-PAD

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of Cat-PAD

  0, 7, 21 days

Secondary Outcomes (1)

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

  Day 21

Study Arms (4)

1

PLACEBO COMPARATOR

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

Biological: Cat-PAD

2

EXPERIMENTAL

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.

Biological: Cat-PAD

3

PLACEBO COMPARATOR

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

Biological: Cat-PAD

4

EXPERIMENTAL

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.

Biological: Cat-PAD

Interventions

Cat-PAD BIOLOGICAL

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

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Circassia Limited: lead

Study Sites (1)

Allergy-Centre-Charité

Berlin, D-10117, Germany

Location

Study Officials

• Margitta Worm, MD Professor

  Allergy-Centre-Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 28, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 6, 2008

Record last verified: 2008-08

Locations

DE (1)