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- Least squares mean (±SE).
- Day-7 means are arithmetic mean values.
- Statistically significant (P<0.0001) compared to placebo.
STUDY DESIGN
This was a randomized, placebo-controlled, masked laboratory study in 40 laboratory Beagles. Dogs were randomly allocated within batch and block to receive on Day 0 by subcutaneous injection with 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 (2.5μg/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).1
