Phase 2 Trial of Icotrokinra for Patients with Ulcerative Colitis.
Maria T Abreu, Britta Siegmund, Lindsey Surace et al.
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In 30 seconds
This phase 2b, double-blind, randomized trial evaluated once-daily oral icotrokinra, an interleukin-23 receptor blocker, in adults with moderately to severely active ulcerative colitis. Among 252 participants, all three doses produced a higher clinical response rate at week 12 than placebo: 63% with 400 mg, 58% with 200 mg, and 55% with 100 mg, versus 27% with placebo (P<0.001 for each comparison). The 400-mg dose also improved clinical and symptomatic remission and endoscopic improvement versus placebo. Adverse-event percentages through week 28 were similar across groups.
Key findings
- At week 12, clinical response occurred in 63%, 58%, and 55% with icotrokinra 400 mg, 200 mg, and 100 mg, respectively, versus 27% with placebo (P<0.001 for all comparisons).
- With 400 mg, clinical remission was 30% vs. 11% with placebo (P = 0.006), symptomatic remission 46% vs. 19% (P<0.001), and endoscopic improvement 37% vs. 14% (P = 0.002).
- Clinical remission with 200 mg was 24% versus 11% with placebo (P = 0.054); further formal testing of secondary end points was not conducted under the trial’s testing procedure.
- Through week 28, adverse events occurred in 60% to 66% of icotrokinra recipients and 62% of placebo recipients; serious adverse events occurred in 0% to 5% and 10%, respectively.
Why it matters
The trial provides evidence that an oral interleukin-23 receptor blocker can improve short-term clinical response in adults with active ulcerative colitis, addressing a treatment route distinct from intravenous or injectable therapies targeting this pathway. The remission and endoscopic results were clearest at the 400-mg dose, while the study’s duration and phase limit conclusions about longer-term benefit and safety.
What to keep in mind
This phase 2 trial assessed outcomes at week 12, with adverse events reported through week 28. The fixed-sequence testing procedure limited formal evaluation of secondary end points after the 200-mg clinical-remission comparison.