


STUDY DESIGN
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.
STUDY DESIGN
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 to Day 0) and by investigators with CADESl-03 (success defined as a ≥50% decrease in CADESl-03 score compared to Day 0).
STUDY DESIGN
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 to Day 0) and by investigators with CADESl-03 (success defined as a ≥50% decrease in CADESl-03 score compared to Day 0).
STUDY DESIGN
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 atopic dermatitis (7—seasonal, 73—non-seasonal), 10 with concurrent food allergy and atopic dermatitis, 45 with atopic dermatitis of undetermined cause, 3 lost to follow-up and 0 flea-allergic dogs (this study was completed in Fort Collins, Colorado).
STUDY DESIGN
This was a multi-centered 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 and the duration of treatment effect. Single doses were administered on study Day 0, then further on Day 30, with Day 60 dependent on clinical response. 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 treatment.
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