Safety of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects With Controlled Asthma

NCT00867906 | Completed Phase 2

• 1 other identifier: CP003
• Study Type: interventional
• Target: 48
• 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 evaluate the safety and tolerability of multiple doses of Cat-PAD in controlled asthmatics treated with either inhaled salbutamol, inhaled corticosteroids or inhaled corticosteroids with a LABA and to explore the efficacy of Cat-PAD in these subjects using the Late Phase Skin Response, Early Phase Skin Response, and Conjunctival Provocation Test.

Conditions

Cat Allergy

Keywords

Cat allergy; Immunotherapy; Cat-PAD

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of multiple intradermal injections of Cat-PAD in cat allergic subjects with controlled asthma

  28 weeks

Secondary Outcomes (4)

• Mean change from baseline in area of the LPSR 8 hours after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo

  28 weeks

• Mean change from baseline in area of the EPSR 15 minutes after intradermal challenge with whole cat allergen at PTC after Cat-PAD injection compared to placebo

  28 weeks

• Mean change from baseline in CPT score at PTC after Cat-PAD injection compared to placebo

  28 weeks

• Mean change from baseline in concentration of cat specific IgE at PTC after Cat-PAD injection compared to placebo

  28 weeks

Study Arms (3)

Cohort 1

OTHER

Asthmatics using salbutamol only, subjects to receive either Cat-PAD or placebo comparator

Biological: Cat-PAD; Biological: Placebo

Cohort 2

OTHER

Asthmatics using inhaled corticosteroid, subjects to receive either Cat-PAD or placebo comparator

Biological: Cat-PAD; Biological: Placebo

Cohort 3

OTHER

Asthmatics using inhaled corticosteroid and LABA, subjects to receive either Cat-PAD or placebo comparator

Biological: Cat-PAD; Biological: Placebo

Interventions

Cat-PAD BIOLOGICAL

Cat-PAD dose 1x8 administrations 2 weeks apart

Cohort 1; Cohort 2; Cohort 3

Placebo BIOLOGICAL

Placebo comparator, 1x8 administrations 2 weeks apart

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

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

You may qualify if:

• Male or female, aged 18-65 years.
• A history of controlled asthma as defined in GINA (2007) on exposure to cats for at least 1 year
• Asthma controlled with:Inhaled salbutamol (Cohort 1), Inhaled corticosteroid (Cohort 2), Inhaled corticosteroid plus a long acting β2agonist (LABA) (Cohort 3) Treatment for asthma must have been stable (drug(s), dose, frequency) for at least 3 months.
• A reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) on exposure to cats for at least 1 year.
• Subjects who provide written informed consent.
• Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
• A LPSR to cat allergen eight hours after intradermal injection of greater than 25mm diameter.
• Positive CPT with a score ≥4.
• The subject must be willing and able to comply with the study requirements.
• If the subject is female and of childbearing potential she must practice an acceptable form of contraception, and produce a negative urine pregnancy test on the Screening Visit. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal.

You may not qualify if:

• Subjects with asthma falling under GINA (2007) definitions "partly controlled" and "uncontrolled"
• Subjects with a requirement for more than 1000 µg beclomethasone (or equivalent) per day for the treatment of asthma.
• 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 wheal diameter \> 30mm.
• Subjects who suffer from seasonal allergic rhinoconjunctivitis, and cannot complete the baseline/post-treatment challenge (PTC) and the dosing periods outside the respective pollen season.
• Allergen immunotherapy during the last 12 months or any history of Cat Dander immunotherapy.
• Subjects who have completed or are undergoing ongoing treatment with anti-IgE-antibody.
• Use of the therapies listed in Section 5.9.2 at any time during the study will make the subject ineligible for the study.
• The subject has unacceptable symptoms in the 3 days without loratadine prior to the screening visit.
• 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.
• Have symptoms of a clinically relevant illness in the Investigator's opinion, within 6 weeks prior to Screening Visit.
• Female subjects who are pregnant, lactating or planning a pregnancy during the study.

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator

Study Sites (1)

Alpha Medical Research

Mississauga, Toronto, Ontario, L5A 3V4, Canada

Location

Study Officials

• Amarjit Cheema, MD

  Alpha Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 6, 2010

Record last verified: 2010-05

Locations

CA (1)