A Field Efficacy and Safety Pilot Study of OKV-1001 for the Treatment of Chronic, Non-Seasonal Moderate-to-Severe Atopic Dermatitis

The University of Florida College of Veterinary Medicine is currently recruiting dogs diagnosed with atopic dermatitis for a clinical research trial.

Enrollment Status: Enrollment on HOLD

• Inclusion Criteria: To be eligible, all dogs need to have a diagnosis of non-seasonal atopic dermatitis.
• Treatment: Dogs will receive the study treatment (mycophenolate) for a total of 56 days. Prednisolone will be administered for the first 20 days of the study. The duration of the entire study is 84 days.

At the first appointment, the dogs will be examined for eligibility to be enrolled in the study. Enrolled dogs will be seen on day 0 (enrollment), 14, 28, 56 (end of the study treatment), and 70 (14 days post-treatment). On day 84 a virtual visit to inquire about side effects and owner overall assessment will be performed.

On each visit (day 0-70), the dogs will undergo a clinical assessment. Pruritus scoring (how itchy the dog is), patient quality of life assessment, and owner global assessment of treatment will be collected from the owner. On day 0 and 56, blood and urine via cystocentesis (inserting a needle through the skin into the bladder) will be collected for organ function testing. If values are altered on day 56 an extra blood draw will be collected on day 70. If a skin infection occurs during the study, or there is a lack of response to the treatment, the dog will be excluded from the study and treated as needed.

• Costs: The study will cover the examination fee, the testing treatment, prednisolone (day 1-20), blood work, urinalysis, and urine culture associated with each visit. No other costs will be covered
• Contact: You can contact our Small Animal Hospital at (352) 392-2235 to schedule an appointment with the Clinical Trial Team. Study Interest Form
• PI: Dr. Domenico Santoro

Background:

Atopic dermatitis (AD) is a very common allergic skin disease associated with abnormalities of the skin barrier and skin inflammation. In dogs suffering with AD, an excessive response to harmless substances (e.g., pollens) can cause severe inflammation. Many of the medications currently used to treat AD do not help quickly, are expensive, or have side effects. Thus, additional treatments are needed. Mycophenolate has been largely used in dogs to treat autoimmune diseases. However, it is used in human medicine to treat inflammatory skin conditions, including moderate to severe AD. Given the similarities between skin allergies in people and dogs, it is reasonable to expect that mycophenolate will also be an attractive treatment option for dogs with such disease. The goal of this study is to test the efficacy of a new formulation of mycophenolate that is more stable and longer lasting than the rapid release formulation currently available on the market.