Cat AllergyPhase 1NCT01383603
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
A Phase 1 study testing Cat-PAD in people with Cat Allergy, run by Circassia Limited at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cat Allergy
- What is being tested?
- Cat-PAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cat Allergy
- Being tested
- Cat-PAD
- Keywords
- Cat Allergy, Rhinoconjunctivitis, Immunotherapy, Cat-PAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cat-PADBiological
Intradermal injection 1 x 4 administrations 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Cat-PAD | Experimental | Not described Receives: Biological: Cat-PAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.
Measured: 6 months following treatment
Secondary outcomes (4)
Symptom scores for ocular and nasal symptoms
Measured: 4 weeks following treatment
Interleukin production and eosinophil level changes
Measured: 4 weeks following treatment
Functional genomic changes
Measured: 4 weeks following treatment
Changes in urine metabolomic profiles
Measured: 4 weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cat AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383603
- Sponsor's protocol ID
- RES-004
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2011
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
- ClinicalTrials.gov ID
- NCT01383603
- Acronym / sponsor ID
- RES-004
- Conditions
- Cat Allergy
- Keywords
- Cat Allergy, Rhinoconjunctivitis, Immunotherapy, Cat-PAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc.
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cat-PAD | Experimental | Biological: Cat-PAD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cat-PADIntradermal injection 1 x 4 administrations 4 weeks apart | Biological | Cat-PAD |
Primary outcome
Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.
Time frame: 6 months following treatment
4 secondary outcomes
Symptom scores for ocular and nasal symptoms
Time frame: 4 weeks following treatment
Interleukin production and eosinophil level changes
Time frame: 4 weeks following treatment
Functional genomic changes
Time frame: 4 weeks following treatment
Changes in urine metabolomic profiles
Time frame: 4 weeks following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Derived from this study: PubMed 29682277Neighbour 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cat-PAD in people with Cat Allergy, run by Circassia Limited at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment. (time frame: 6 months following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01383603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.