This was a randomized, placebo-controlled, masked laboratory study in 40 laboratory beagles. On Day 0, dogs received a subcutaneous injection of either placebo (n=20) or CYTOPOINT® at 2.0 mg/kg (n=20). Pruritus was induced in all dogs on study Days -7 (±2), 1 and 28 (±1) by intravenous (IV) challenge with IL-31 (2.5 μg/kg). Pruritus scores were measured by a masked observer for 120 minutes following administration of IL-31; specifically, at consecutive 1-minute intervals, “yes”/“no” decisions were made in regards to whether a pruritic behavior was displayed by each dog within the 120-minute observation period, resulting in a maximum possible total score of 120. 

A single 2.0 mg/kg dose of CYTOPOINT® (n=50) or placebo (n=52) was administered subcutaneously on Day 0 in this randomized, double-blind, placebo-controlled study of dogs diagnosed with atopic dermatitis. The primary effectiveness endpoints were treatment success in pruritus as assessed by owners on a VAS (success defined as a ≥20 mm reduction in pruritus scores compared with Day 0) and by investigators with CADESl-03 (success defined as a ≥50% decrease in CADESl-03 score compared with Day 0). 

A single 2.0 mg/kg dose of CYTOPOINT® (n=50) or placebo (n=52) was administered subcutaneously on Day 0 in this randomized, double-blind, placebo-controlled study of dogs diagnosed with atopic dermatitis. The primary effectiveness endpoints were treatment success in pruritus as assessed by owners on a VAS (success defined as a ≥20 mm reduction in pruritus scores compared with Day 0) and by investigators with CADESl-03 (success defined as a ≥50% decrease in CADESl-03 score compared with Day 0).

This study was an independent, real-world, retrospective analysis of medical records of dogs with allergic dermatitis treated with CYTOPOINT® from November 2015 to October 2016. Treatment success for owner-assessed pruritus was empirically defined as a ≥2 cm reduction in Pruritus Visual Analog Scale (PVAS) from baseline. The 135 dogs in this study included 80 with allergic dermatitis (7—seasonal, 73—non-seasonal), 10 with concurrent food allergy and atopic dermatitis, 45 with allergic dermatitis of undetermined cause, 3 lost to follow-up and 0 flea-allergic dogs (this study was completed at Colorado State University in Fort Collins, Colorado).

This was a multicentered prospective open observational phase IV study with an objective of understanding the efficacy of 3 monthly dosages of CYTOPOINT® in dogs with atopic dermatitis (AD) (n=110). Dogs were evaluated weekly for pruritus and monthly for clinical signs of AD to understand the benefit of consecutive monthly dosing. Single doses were administered on study Day 0. Dogs who achieved treatment success left the study at the evaluation on Day 30 while dogs who had not achieved treatment success were administered a second injection of CYTOPOINT at label doses. This process repeated with a new evaluation at Day 60 and administration of a third injection of CYTOPOINT for dogs who had not achieved treatment success.

Treatment success was defined as achieving a 20 mm reduction in PVAS from baseline. Inclusion and exclusion criteria were intended to ensure enrollment of dogs with AD but without other concurrent disease or pharmaceutical treatments that could confound the study. Dogs had a documented history of non-seasonal AD or seasonal AD where prior history supported disease preferences for at least 4 months following initiation of treatment.