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CompletedNCT01383590Updated Jan 22, 2014

Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis

A Phase 1 interventional study of Cat-PAD in Cat Allergy, sponsored by Circassia Limited. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-22.

Sponsored by Circassia Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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 desensitizing vaccine currently being developed for the treatment of cat allergy.

At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. The aim of this study is to identify changes in potential biomarkers after peptide immunotherapy that may be subsequently developed as biomarkers that equate with clinical efficacy.

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Conditions studied

  • Cat Allergy

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Keywords

  • Cat allergy
  • Rhinoconjunctivitis
  • Immunotherapy
  • Cat-PAD
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In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 10 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Circassia Limited is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or Female, aged 18-65 years
  • A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats.
  • Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
  • 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

Exclusion Criteria:

  • History of asthma
  • A history of anaphylaxis to cat allergen
  • A history of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments
  • A 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)
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Cat-PAD

    Biological: Cat-PAD

Interventions

  • BiologicalCat-PAD

    Intradermal injection 1 x 4 administrations 4 weeks apart.

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What researchers measure

Primary outcomes

  1. Identification of potential plasma biomarkers of response to peptide immunotherapy

    Blood samples derived from the study will be submitted for proteomics analyses aimed at the identification of one or more plasma proteins whose concentration over the course of the study varies in relation to the treatment administered. The outcome will be determined on the basis of measurements from samples collected over a period commencing prior to treatment and ending 6 months following treatment.

    Time frame: 6 months following last treatment

Secondary outcomes

  1. Symptom scores for ocular and nasal symptoms

    Time frame: 4 weeks following treatment

  2. Interleukin production and eosinophil level changes

    Time frame: 4 weeks following treatment

  3. Functional genomic changes

    Time frame: 4 weeks following treatment

  4. Changes in urine metabolomic profiles

    Time frame: 4 weeks following treatment

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Study locations

1 site
  • Kingston General Hospital
    Kingston, Ontario K7L 2V7, Canada
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References and documents

Publications

  • 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. PubMed 29682277 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01383590
Lead sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.
Responsible party
Sponsor
First posted
Jun 28, 2011
Start date
Oct 2011
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jan 22, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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