Investigation of New Treatment for Allergic Skin Disease in Dogs Phase II

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

Enrollment Status: Currently Enrolling

Inclusion Criteria: To be eligible, the client-owned dog needs to be:

· Clinically diagnosed with allergic dermatitis

· 12 months of age or older

· Weight greater than or equal to 3 kg (6.6 lbs)

· No active bacterial or fungal skin infection at time of enrollment

· On consistent flea and tick prevention throughout the study

· On consistent diet throughout the study

Treatment: Enrolled dogs will receive either the study treatment (JAK-inhibitor) or a positive control treatment orally at home daily for a total of 28 days. Some dogs will have the option to continue for an additional 84 days.

Each participating dog will receive an initial evaluation performed by a veterinary dermatologist at the University of Florida Small Animal Hospital on Day 1, as well as bloodwork and a urinalysis. Each dog will need to have Visit 2 scheduled for Day 14, and Visit 3 for Day 28. On Visit 3 bloodwork and a urinalysis will be repeated. Owners will be responsible for filling out a Pruritus Visual Analog Scale (PVAS) daily throughout the study.

Cost: This study will cover the cost of dermatological examination, a complete blood count (CBC), serum chemistry, urinalysis, and any rescue medications during the study trial if necessary. Additionally, owners will receive a $350 credit on their UF Small Animal Hospital account at the completion of this study, as well as a one-month supply of dog food and flea prevention of the owner’s choice.

Contact: Contact study coordinator Nathalie Munguia at NMUNGUIA@UFL.EDU or fill out the Study Interest Form to schedule an appointment.

PI: Dr. Rosanna Marsella

Background: Canine allergic dermatitis is an inflammatory skin disease with many symptoms, but is mainly characterized by pruritus (itchiness) and secondary inflammation. The goals of this study are to treat the underlying cause of itch in enrolled patients, consequently reducing itch levels and allowing the skin proper time to heal. The current available therapies for controlling pruritus include systemic glucocorticoids, a calcineurin inhibitor, a Janus kinase (JAK) inhibitor, and a monoclonal antibody targeting IL-31. Patients have variable responses to these therapies both in terms of sufficiency of response and long-term tolerability. Therefore, there is an unmet need for a new safe and effective oral therapy for the control of pruritus associated with allergic dermatitis. This study is designed to evaluate the safety and efficacy of a selective JAK inhibitor. JAK inhibitors block the activity of Janus kinase proteins which are known to play a significant role in the immune system signals that cause itch, inflammation, and allergies.