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Cat AllergyPhase 2NCT02311413

A Randomized Prospective Clinical Trial of Fel d 1 Peptide Immunotherapy

A Phase 2 study testing Cat-PAD in people with Cat Allergy and Cat Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to identify changes in cells that are related to the treatment with Cat-PAD (ToleroMune Cat). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cat Allergy, Cat Hypersensitivity
What is being tested?
Cat-PAD
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteCanada
Study dates
9 Mar 2015to 18 Jul 2018
Phase
Phase 2
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who meet all of the following criteria are eligible for enrollment as study participants:
  • Subject must be able to understand and provide informed consent;
  • Subjects without asthma or with asthma who are on Global Initiative for Asthma (GINA) Step 1 treatment with an inhaled short-acting beta2-agonist or GINA Step 2 or 3 treatment with an inhaled corticosteroid. Treatment for asthma must have been stable (drug(s), dose, frequency) for at least 4 weeks prior to randomization. The dose of inhaled corticosteroids must not be greater than 500 microg fluticasone or equivalent (e.g.>00 microg budesonide; or >400 microg mometasone) per day for the treatment of asthma;
  • A minimum 1-year documented history of allergic rhinoconjunctivitis on exposure to cats;
  • Positive skin prick test to cat hair (wheal diameter 3mm larger than negative control. Cat specific IgE greater than or equal to 0.35IU/ml;
  • Subjects must express one (or more) of the following Human Leukocyte Antigens (HLA): HLA-DRB1*0101, HLA-DRB1*0301, HLA-DRB1*0401, HLA-DRB1*0405, HLA- DRB1*0701, HLA-DRB1*0901, HLA-DRB1*1001, HLA-DRB1*1101, HLA-DRB1*1301, HLA-DRB1*1401, HLA-DRB5*0101. Not limited to the above listed HLA as more may become available in the future;
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  • FEV1 must not decrease >20% from baseline prior to nasal allergen challenges, that does not return to baseline after inhalation of 200µg of Salbutamol. Baseline is defined as the FEV1 value at Visit Pre-Screening;
  • Screening nasal allergen challenge in which TNSS is less than or equal to 4 at baseline and greater than or equal to after the highest dose, and
  • --Between the first non-zero dose and 10 minutes after the highest dose, either;
  • 3 or more sneezes are counted, or
  • greater than 20% drop in PNIF is recorded, at the discretion of the Physician;
  • Subjects must have regular exposure (minimum 1 hour exposure twice per week) to a cat in their normal living or working circumstances;
  • Willing and able to comply with the study requirements;
  • If the subject is female and of childbearing potential she must have been stable on highly effective contraceptive methods for at least 3 months prior to screening and continue during the study, and produce a negative urine pregnancy test at all visits. 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. Highly effective contraceptive methods may include:
  • Total sexual abstinence for the total duration of the study including washout periods;
  • Vasectomised sexual partner (with appropriate post-vasectomy documentation of the absence of sperm in ejaculate) + male condom;
  • Tubal occlusion + male condom;
  • Intrauterine device (IUD), provided coils are copper banded + male condom;
  • Intrauterine system (IUS) Levonorgestrel, e.g. Mirena + male condom;
  • Medroxyprogesterone injections (Depo-Provera) + male condom;
  • Etonogestrel implants (e.g. Implanon, Norplant) + male condom;
  • Normal and low dose combined oral pills + male condom;
  • Norelgestromin /EE transdermal system + male condom;
  • Intravaginal device, e.g. EE and etonogestrel + male condom;
  • Cerazette(TM) (desogestrel) + male condom.

Who cannot join

  • Individuals who meet any of these criteria are not eligible for enrollment as study participants:
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
  • Asthma symptoms that have been unstable in the 12 weeks prior to study entry or requirement of oral corticosteroids to treat asthma in the 6 months prior to study entry in the 12 weeks prior to randomization;
  • Any history of intubation/life-threatening episode for asthma exacerbation;
  • Hospitalization for asthma in the year prior to screening.;
  • A history of anaphylaxis to cat allergen. As defined by; (1) more than one organ system involvement with symptoms such as urticaria, wheezing, shortness of breath, abdominal pain, vomiting, (2) presence of hypotension or cyanosis, or loss of consciousness;
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  • Subjects with an FEV1 <0% of predicted;
  • Subjects with an FEV1/FVC ratio of < 70;
  • History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment;
  • At time of screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Subjects may be re- evaluated for eligibility after symptoms resolve and will maintain the same Subject Screening number;
  • The subject has unacceptable symptoms in the 5 days without oral antihistamines prior to the screening visits;
  • Treatment with omalizumab within 6 months of screening;
  • Previous allergen immunotherapy for cat allergy;
  • Subjects for whom administration of epinephrine is contra-indicated;
  • Subjects treated with beta-blockers;
  • 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;
  • Any clinically relevant abnormalities on physical examination;
  • Vital signs (blood pressure, pulse, respiratory rate, body temperature) outside normal limits unless considered not to be clinically relevant by the Investigator;
  • Laboratory values (haematology, biochemistry, urine tests) outside the normal ranges, unless considered not to be clinically relevance by the Investigator. Hemoglobin must be greater than 12g/dl at visits 1, 3 and 4. If the hemoglobin is <12g/dl the visit can be rescheduled within 2 weeks at the discretion of the investigator/physician and the hemoglobin measurement repeated at the subsequent visit;
  • History of alcohol or drug abuse;
  • History of immunopathological diseases which may confound study outcomes;
  • Previous participation in any Cat-PAD study;
  • A history of severe drug allergy, severe angioedema or anaphylactic reaction to food;
  • Received treatment with an investigational drug within 3 months prior to study;
  • Unable to communicate or to understand the requirements of the study, which would impair communication between subject and Investigator thereby interfering with the informed consent procedure or the gathering of study data;
  • 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) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study;
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study;
  • A known allergy to thioglycerol;
  • Known history of positive test results for Hepatitis B, Hepatitis C, HIV or tuberculosis other than would be anticipated following vaccination.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: The Effect of Peptide Immunotherapy on Frequency, Memory Phenotype, Chemokine Receptor Expression and Markers of Regulatory T Cell Function Among Allergen-Specific T Cells

The goal of this study is to identify changes in cells that are related to the treatment with Cat-PAD (ToleroMune Cat).

Read the detailed description

Cat-PAD is an experimental cat allergy vaccine and has been studied to determine if it can reduce symptom scores of participants exposed to cat allergen. To study how the vaccine causes changes in the immune system, the researchers plan to evaluate changes in the blood (genes and proteins) and urine in response to the Cat-PAD vaccine.

Being tested
Cat-PAD, Placebo
Keywords
Allergic rhinoconjunctivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cat-PADDrug

    Also called ToleroMune Cat

    The assigned study intervention will be administered by intradermal injection into the flexor surface of the forearm.

  • PlaceboDrug

    Also called Cat-PAD Placebo

    The assigned study intervention will be administered by intradermal injection into the flexor surface of the forearm.

Study groups in NCT02311413
Study groupRoleWhat they receive
Cat-PADExperimentalSubjects will be treated with four monthly doses of Cat-PAD, a peptide immunotherapy product consisting of Fel d 1 synthetic peptide immunoregulatory epitopes (SPIRE).
Receives: Drug: Cat-PAD
PlaceboPlacebo comparatorSubjects will be treated with 4 monthly doses of Placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the area under the curve (AUC) from 0 to 6 hour for total nasal symptom score (TNSS).

    This outcome will be analyzed using analysis of covariance (ANCOVA) where the difference in mean AUC between the untreated and treated groups will be compared while statistically controlling for the effects of the baseline AUC.

    Measured: Following nasal allergen challenge , one year after initiation of peptide immunotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2014 (estimated)
  2. Study start9 Mar 2015
  3. Primary completion18 Jul 2018
  4. Study completion18 Jul 2018

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02311413
Sponsor's protocol ID
DAIT U19-MMU-02
Other IDs
U19AI100266
Status last verified
Oct 2018
First submitted
4 Dec 2014
Last updated
2 Nov 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cat-PAD in people with Cat Allergy and Cat Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 25 inclusion and 30 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 2 Nov 2018. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in the area under the curve (AUC) from 0 to 6 hour for total nasal symptom score (TNSS). (time frame: Following nasal allergen challenge , one year after initiation of peptide immunotherapy.). 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 NCT02311413.

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 2 Nov 2018.

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