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For patients with moderately to severely active ulcerative colitis, oral icotrokinra, a peptide that blocks the interleukin-23 receptor, yields a clinical response at week 12 significantly more often than placebo, according to a study published in the Oct. 15 issue of the New England Journal of Medicine.

Maria T. Abreu, M.D., from Cedars Sinai in Los Angeles, and colleagues conducted a phase 2, double-blind, randomized trial of oral icotrokinra in adults with moderately to severely active ulcerative colitis. Participants were randomly assigned to receive icotrokinra at a once-daily dose of 400 mg, 200 mg, or 100 mg or placebo (63, 62, 64, and 63 individuals, respectively).

The researchers found that with respect to a clinical response at week 12, all icotrokinra doses were superior to placebo (63%, 58%, and 55% versus 27% in the 400-, 200-, and 100-mg groups versus placebo, respectively). Compared with the placebo group, the 400-mg group had significantly higher percentages of participants with clinical remission at week 12 (30% versus 11%), participants with symptomatic remission (46% versus 19%), and participants with endoscopic improvement (37% versus 14%).

The percentage of participants with adverse events was 60%, 66%, 66%, and 62% in the 400-, 200-, and 100-mg groups and the placebo group, respectively, through week 28; the corresponding percentages of serious adverse events were 2%, 5%, 0%, and 10%.

"Icotrokinra was effective even in hard-to-treat patients who had failed previous drug regimens," Abreu said in a statement.

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