Dermatology For Animals Blog

A Pilot Multicenter Field Study of a Novel Oral Therapeutic in Dogs with Moderate-to-Severe Canine Atopic Dermatitis

Dermatology for Animals is currently enrolling cases in a nationwide clinical trial to evaluate novel therapeutic designed to inhibit inflammation in dogs with moderate-to-severe atopic dermatitis. The study is designed to assess the benefit after a course of prednisone or independently.

CLINICAL STUDY DETAILS

Trial Summary

An estimated 55 client-owned dogs will be enrolled
in this study. At enrollment, dogs will be randomized 4:1 prednisone to study drug. Those dogs randomized to receive prednisone will then be randomized again at Day 14 if pruritus and skin lesions caused by atopy have improved adequately. The veterinary dermatologist, and dog owner, will be masked to treatment group assignment. Study visits are required every 2 weeks for one month, and then monthly thereafter. The study duration is 4 months; however, if the dog does not respond to prednisone treatment or experiences a flare of atopic dermatitis after enrollment, the dog may be removed from study.

Trial Funding

Dogs presenting to the participating trial site will
be screened for enrollment. All study related costs, including screening, are paid by the study. Either IgE serology (through IDEXX) or intradermal skin testing will be needed if not previously performed. Although previous studies with this drug have not demonstrated significant side effects , the study will pay up to $250 for medical management of adverse effects if they are thought to be a result of the study drug. If these funds are not used in full during the course of the study, the balance will be available to study pet owners for follow-up dermatology care.

Trial Eligibility

To qualify for enrollment, dogs must meet the following criteria:

•  Client-owned dog > 1 year of age
•  Body weight ≥ 5.0 kg
•  Diagnosis of Atopic Dermatitis based on clinical signs, rule-out of resembling conditions (e.g. flea allergies, ectoparasites and bacterial  or yeast skin infections). For homogeneity purposes, dogs with food-induced AD will be eliminated from inclusion.
•  Non-seasonal Atopic Dermatitis
•  More than 3 positives on allergen-specific IgE serology or intradermal testing
•  Canine Atopic Dermatitis Extent and Severity Index-4 (CADESI-4) Score of ≥ 35
•  Pruritus Score ≥ 5.5
•  Use of a veterinarian recommended flea product, in endemic areas, for a minimum of 3 months.

Dogs cannot be enrolled if there has been:

• Use of the following medications from the time of enrollment:
  1. Injectable long-acting glucocorticoids in the past 6 weeks
  2. Oral glucocorticoids, cyclosporine, calcineurin inhibitors, long-acting injectable antimicrobial agents or agents with known   anti-pruritic activity (Staphage Lysate, gabapentin, monoamine oxidase inhibitors and tacrolimus) in the past 4 weeks
  3. Topical nonsteroidal anti-inflammatory drugs and topical glucocorticoids in the past 3 weeks
  4. Anti-histamines and oclacitinib in the past two weeks
  5. Oral antibacterial or antifungal agents in the past week
• Use of allergen-specific immunotherapy initiated in the last year (If allergen-specific immunotherapy has been used for more than 1 year, dog is still eligible)
• History of seasonal Atopic Dermatitis
• Evidence of ectoparasites or bacterial or yeast infection
• Change of food or food supplements (fatty acids, omega-3s) within the last 6 weeks
• Dog is pregnant, likely to become pregnant or   intended for breeding
• Dog has another major medical condition requiring pharmaceutical intervention
• Dog has a serum chemistry, hematology or UA finding that is, in the opinion of the Investigator, clinically significant and may indicate a concomitant illness.
• Dog is participating in another study
• Dog may not be available for the entire study duration
• Owners unable or unwilling to assess pruritus throughout the study