Study design
UC
DISEASE
This was a randomized, placebo controlled, investigator‐ and patient‐blinded study to assess the safety, tolerability, PK and PD of selnoflast in patients with moderate to severe active UC. The sponsor teams and study personnel were fully blinded, with the exception of selected individuals (e.g., in the analysis laboratories), who had to be unblinded in order to identify the correct samples for PK analysis. A total of 19 patients were enrolled. All had been previously diagnosed with UC and were in an active stage of their disease during the study. Patients were randomized 2:1 to receive either 450 mg selnoflast orally or placebo. The treatment duration was 7 days (at the clinic). Patients were recruited and enrolled at one study site in Berlin, Germany, between December 2021‐June 2022. The dose of 450 mg administered once daily was selected based on the results from an entry‐in‐humans (EIH) study in healthy subjects, where it was well tolerated over 7 days of treatment and showed 99% inhibition of IL‐1β release up to 10 h post‐dose in ex vivo stimulated whole blood, and over 90% inhibition over the dosing interval, compared to baseline (unpublished results).The study protocol was approved by the institutional review board of the participating study site and complied with the Declaration of Helsinki. All patients provided written informed consent prior to starting the study.