RELIEVE UCCD: Duvakitug’s Efficacy and Favorable Safety in Crohn’s Disease, With Jairath, MBChB, DPhil

New results from the phase 2b RELIEVE UCCD basket trial reported on the efficacy, safety, and tolerability of Teva Pharmaceuticals and Sanofi’s investigational monoclonal antibody duvakitug in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s Disease (CD) compared to placebo.1

The findings, presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting by Vipul Jairath, MBChB, DPhil, a professor of medicine, epidemiology, and biostatistics at Western University, demonstrated a statistically significant and clinically meaningful endoscopic response with no emergent safety signals in the patient population.

Duvakitug, a human IgG1-λ2 monoclonal antibody targeting TL1A (tumor necrosis factor superfamily member 15), is designed to modulate inflammation and fibrosis associated with the pathogenesis of inflammatory bowel disease. The phase 2b RELIEVE UCCD study was a randomized, placebo-controlled, double-blind induction trial that evaluated duvakitug in UC and CD under a common basket protocol. The study met its primary endpoints of clinical remission in UC and ≥50% reduction from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD) in CD, as reported in December 2024.2

“Again, you see a proof of mechanism suggesting that this class of drugs is beneficial in both UC and CD in the phase 2 program, and these have now moved forward into pivotal trials,” said Jairath in an interview with HCPLive.

Participants were primarily randomly assigned to receive a 2250 mg subcutaneous loading dose of duvakitug or placebo, followed by a dose of duvakitug 450 mg (n = 46), 900 mg (n = 46), or placebo (n = 46) administered every 2 weeks.

The study enrolled 138 adults with moderately to severely active CD with prior documented inadequate response, loss of response, or intolerance to conventional and/or advanced therapies (ATs). Participants were stratified by prior recorded ATs.

Investigators observed a durable efficacy in both duvakitug doses, 26% of patients receiving 450 mg and 48% receiving 900 mg achieved the primary endpoints, compared with 13% of the placebo group. Endoscopic response rates based on the prespecified Bayesian analysis were 13% (450 mg) and 35% (900 mg) after placebo adjustment.

Safety outcomes were consistent with previous reports. The incidence of adverse events was similar between duvakitug 900 mg (43%) and placebo (48%), though higher in the duvakitug 450 mg group (67%). Adverse events leading to discontinuation occurred in 9% of patients receiving duvakitug 450 mg and 2% of those on duvakitug 900 mg or placebo.

“In the phase 2 trial, no new safety signals have been detected with duvakitug beyond what we expected when treating patients with Crohn's disease or ulcerative colitis,” said Jairath.

Editor’s Note: Jairath reports relevant disclosures with AbbVie, Alimentiv, Arena, and others.

References

1. Jairaith, V, Kierkuś, J, Duvall, A, et al. Duvakitug, an anti-TL1a mAb, Demonstrates Efficacy and Favorable Safety as an Induction Treatment in Adults With Moderately to Severely Active Crohn’s Disease: Results From the RELIEVE UCCD Phase 2b Basket Trial. Presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting. Phoenix, Arizona. October 27-29, 2025.

2. Press release: Duvakitug positive phase 2B results demonstrate best-in-class potential in ulcerative colitis and crohn’s disease. Sanofi. December 17, 2024. Accessed November 13, 2025. https://www.sanofi.com/en/media-room/press-releases/2024/2024-12-17-12-30-00-2998154