Investigator-sponsored rilonacept study for autoimmune neurosensory hearing loss
Also known as: Rilonacept, Arcalyst, IL-1 Trap
Investigator-sponsored study (Stanley Cohen, MD)
Subcutaneous interleukin-1 blocker/cytokine trap. The Arcalyst label describes rilonacept as binding IL-1 alpha and IL-1 beta as a soluble decoy receptor, while the hearing study tested whether IL-1 blockade could improve autoimmune neurosensory hearing loss.
Verified as a real open-label investigator-sponsored pilot study of rilonacept/Arcalyst in autoimmune neurosensory hearing loss. ClinicalTrials.gov lists Stanley Cohen, MD as sponsor-investigator with Metroplex Clinical Research affiliation and Regeneron Pharmaceuticals as an industry collaborator; this should not be represented as a Regeneron hearing-loss pipeline program. The ClinicalTrials.gov record remains Unknown with last-known Recruiting status, has not been updated since September 2017, and has no posted results. DailyMed currently lists Arcalyst/rilonacept under Kiniksa labeling and confirms the IL-1 blocker mechanism and subcutaneous route, but the approved indications are not hearing-loss indications.