A masked, randomised clinical trial evaluating the efficacy and safety of lokivetmab compared to saline control in client‐owned dogs with allergic dermatitis

BACKGROUND: Interleukin (IL)‐31 is an important mediator in canine atopic dermatitis (cAD) and also may be dysregulated in other allergic diseases. HYPOTHESIS/OBJECTIVES: To demonstrate the efficacy and safety of lokivetmab (canine anti‐IL‐31 monoclonal antibody) for treatment of pruritus associated with allergic dermatitis in dogs. ANIMALS: Dogs that were at least moderately pruritic with a presumptive diagnosis of allergic dermatitis were enrolled in Portugal, Hungary, France and Germany by 12 primary care practitioners and two veterinary dermatology referral specialists. METHODS AND MATERIALS: Dogs were randomised to receive either placebo (saline) or lokivetmab (1.0–3.3 mg/kg) by subcutaneous injection on Day (D)0. Owners evaluated pruritus using a validated Visual Analog Scale (pVAS) daily until D7 and then weekly until D28. The severity of dermatitis was assessed by the investigators using a modified VAS on D0, D7, D14 and D28. RESULTS: Beginning at D1, owner‐assessed pVAS least square means were significantly reduced in the treatment group versus the placebo group (57.7% versus 21.8% reduction on D28). For all time points, investigator‐assessed VAS means were significantly reduced in the lokivetmab group versus the placebo group (57.1% versus 20.5% reduction on D28). Overall, the occurrence of adverse health events during the evaluation period was comparable between the two groups. CONCLUSIONS AND CLINICAL IMPORTANCE: Lokivetmab is a safe and efficacious treatment for dogs with allergic dermatitis.