Phase 2b RCT (RELIEVE UCCD) evaluated duvakitug — an 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 137 adults aged 18–75 with moderately to severely active ulcerative colitis over 14 weeks.
Clinical remission (modified Mayo score) at week 14 was achieved by 36% (17/47) in the 450 mg group and 48% (22/46) in the 900 mg group, versus 20% (9/44) with placebo. Posterior probabilities of superiority to placebo were 0.95 (450 mg) and >0.99 (900 mg), both exceeding the prespecified 0.90 threshold. Adverse event rates were similar across all three arms (~43–52%).
- Small sample sizes (n≈44–47 per arm) limit precision; the 95% credible interval for the 450 mg dose crossed zero (−3 to 33%). - Short 14-week primary endpoint; longer-term efficacy and safety are unknown. - Population was 96% White, limiting generalizability.
Duvakitug 900 mg every 2 weeks showed the clearest efficacy signal for inducing remission in moderate-to-severe UC, with a safety profile comparable to placebo at this early phase. Clinicians should await phase 3 data before considering this agent, as it is not yet approved.
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