- Design
- Phase 2b, double-blind, randomised, placebo-controlled trial (ANTHEM-UC)
- Population
- 252 adults with moderately to severely active ulcerative colitis
- Primary outcome
- Clinical response at week 12
- Effect
- 63% (400 mg), 58% (200 mg), 55% (100 mg) vs 27% placebo; P<0.001 for each
ANTHEM-UC randomised adults with active ulcerative colitis to one of three daily doses of oral icotrokinra or placebo. Icotrokinra is a peptide that blocks the IL-23 receptor in the gut.
All doses improved clinical response at 12 weeks. At the highest dose, remission and endoscopic improvement were also more frequent. Under the trial's fixed testing sequence, formal testing stopped when remission at 200 mg narrowly missed significance.
Phase 3 trials will determine whether this translates into durable remission. For now it is a pipeline result to watch rather than a change to treatment.
- Clinical response at week 12 was 63%, 58% and 55% across doses against 27% on placebo.
- Clinical remission was 30% at 400 mg against 11% on placebo.
- Endoscopic improvement was 37% at 400 mg against 14%.
- Serious adverse events were no more frequent than placebo through week 28.
- Availability in India is not established; current options remain injectable IL-23 and other biologics.
Why it matters
IL-23 therapies work in IBD but need injections or infusions; a daily tablet would change how they are used.
Don't overread it
This is a 12-week phase 2b trial; durability, longer-term safety and head-to-head data are not yet available.
The statistics, in plain English
Fixed-sequence testing protects against false positives by stopping formal tests after the first non-significant result. Later secondary outcomes are therefore descriptive only.
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