Clinical trial NCT01383603: Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
Official title: Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cat Allergy
Keywords: Cat Allergy
Rhinoconjunctivitis
Immunotherapy
Cat-PAD
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
First posted: 2011-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis. Cat-PAD is a novel, synthetic, allergen derived peptide desensitising vaccine currently being developed for treatment of cat allergy.

At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical development of peptide immunotherapy vaccines, in addition to providing an improved understanding of the underlying molecular mechanisms of efficacy, thus providing new leads for therapeutic intervention.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-65 years.
* Weight \>50 kg.
* A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats.
* Positive skin prick test to cat allergen.
* Subjects must have regular exposure to a cat in their normal living or working circumstances throughout the course of the study.
* Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion Criteria:

* History of asthma
* History of anaphylaxis to cat allergen
* History of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments
* History of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis)

Primary outcomes:
measure: Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.
timeFrame: 6 months following treatment
Secondary outcomes:
measure: Symptom scores for ocular and nasal symptoms
timeFrame: 4 weeks following treatment
measure: Interleukin production and eosinophil level changes
timeFrame: 4 weeks following treatment
measure: Functional genomic changes
timeFrame: 4 weeks following treatment
measure: Changes in urine metabolomic profiles
timeFrame: 4 weeks following treatment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References:
citation: Neighbour H, Soliman M, Steacy LM, Hickey P, Forbes B, Larche M, Ellis AK. The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC): verification of nasal allergen challenge procedures in a study utilizing an investigational immunotherapy for cat allergy. Clin Transl Allergy. 2018 Apr 12;8:15. doi: 10.1186/s13601-018-0198-7. eCollection 2018.