This phase 2b RCT evaluated duvakitug (anti-TL1A monoclonal antibody) at two subcutaneous doses (450 mg or 900 mg every 2 weeks after a 2250 mg loading dose) versus placebo in 138 adults aged 18–75 with moderately to severely active Crohn's disease, including 57% previously exposed to advanced therapies, over 14 weeks.
Endoscopic response (≥50% reduction in SES-CD) at week 14 was achieved by 48% with duvakitug 900 mg vs. 13% with placebo (posterior probability of superiority >0.99); the 450 mg dose reached 26% vs. 13% placebo (posterior probability 0.94, meeting the pre-specified 0.90 threshold). Serious adverse events were low and comparable across groups (13% at 450 mg, 2% at 900 mg, 11% placebo).
Small sample size (~46 per arm) limits precision; study population was 95% White, limiting generalizability; 14-week endpoint does not address long-term durability or maintenance of response.
Duvakitug 900 mg SC every 2 weeks showed a clinically meaningful endoscopic response rate in biologic-experienced Crohn's disease patients with a favorable short-term safety profile. Phase 3 trials will be needed to confirm durability and establish its role relative to existing advanced therapies.
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