Safety and tolerability of anti-toll-like receptor 3, monoclonal antibody PRV-300 in patients with moderate-to-severe ulcerative colitis: a randomized phase 1B clinical trial (PULSE)

Background & aims: PRV-300 is a fully human IgG4κ monoclonal antibody that binds the extracellular domain of human toll-like receptor 3, which is overexpressed in the inflamed colonic epithelium in patients with inflammatory bowel disease. This study aimed at proving its safety and efficacy in patients with ulcerative colitis (UC).

Methods

Patients with moderate-to-severe UC (Mayo Clinical Score [MCS] 6-12) were randomized to receive 7 doses of PRV-300 intravenously or matched placebo (PBO). After a 12-week treatment period, participants underwent an 8-week follow-up. The primary endpoint was to assess the safety and tolerability of PRV-300. Secondary endpoints included assessment of pharmacodynamics, pharmacokinetics, immunogenicity, and endoscopic disease activity.