A Randomized Prospective Clinical Trial of Fel d 1 Peptide Immunotherapy

NCT02311413 | Completed Phase 2 DMC

• 2 other identifiers: DAIT U19-MMU-02U19AI100266
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cat Allergy; Cat Hypersensitivity

Keywords

Allergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

Cat-PAD

EXPERIMENTAL

Subjects will be treated with four monthly doses of Cat-PAD, a peptide immunotherapy product consisting of Fel d 1 synthetic peptide immunoregulatory epitopes (SPIRE).

Drug: Cat-PAD

Placebo

PLACEBO COMPARATOR

Subjects will be treated with 4 monthly doses of Placebo.

Drug: Placebo

Interventions

Cat-PAD DRUG

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

Also known as: ToleroMune Cat

Cat-PAD

Placebo DRUG

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

Also known as: Cat-PAD Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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;
• 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;
• 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;

You may not qualify if:

• 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;
• 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;
• 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;

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Circassia Limited: collaborator

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

Study Officials

• Helen Neighbour

  Saint Joseph's Healthcare

  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: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: March 9, 2015
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-10

Locations

CA (1)