Evaluation of the safety and efficacy of a new innate immunotherapy for treatment of sarcoids in the horse

About the study

Sarcoids are the most common skin tumor in the horse. Currently, there is no consistent therapy for treatment of sarcoids. The goal of this study is to determine if injection of a novel immunotherapy can safely lead to cure (remission) or significantly decrease the size of sarcoids in standing horses.

The new treatment used in this study is investigational, and the safety and efficacy of this product for the treatment of sarcoids in horses has not been established.

All horses enrolled in this study will receive the treatment called lip-stimulator of interferon genes (STING) we are investigating.

Horses must have skin masses with an appearance consistent with sarcoids. A previous biopsy is not necessary for enrollment.

Study design

As part of this clinical trial, each horse will have the following things done at each treatment exam:

• complete physical exams
• blood draw to assess his/her general health as well as collection of blood for lab testing (total of 16 milliliters of blood)
• photographs and measurements of sarcoids
• mild IV sedation for the injections
• topical application of a numbing cream (prilocaine/lidocaine) to the area that will be injected.
• sampling of the sarcoid if portions of the tumor are shedding, at pretreatment and following the first and second injection
• injection of 1 milliliter of lip-STING around the sarcoid; if there are multiple sarcoids, only the largest sarcoid will be injected – injections will occur every four weeks using lip-STING for a total of three injections
• daily photographs of the injection area will be sent to the study investigator via email for five days following each injection
• appointments required for the study include baseline, four weeks, eight weeks, 12 weeks for the three treatments then three months and nine months after the last injection (study total of 11 months)