Phase 2 Trial of Icotrokinra for Patients with Ulcerative Colitis

Monoclonal antibodies targeting the interleukin-23 pathway are effective in treating inflammatory bowel disease. However, these therapies must be administered intravenously or by subcutaneous injection.

We conducted a phase 2b, double-blind, randomized trial of oral icotrokinra, a peptide that blocks the interleukin-23 receptor, in adults with moderately to severely active ulcerative colitis. Participants were assigned to receive icotrokinra at a once-daily dose of 400 mg, 200 mg, or 100 mg or placebo. The primary end point was clinical response at week 12. Secondary end points included clinical remission, remission of symptoms, and endoscopic improvement at week 12.