TL1A Antibody Duvakitug Boosts Clinical Remission in UC, Response in CD

The Lancet Gastroenterology & Hepatology has published detailed efficacy and safety findings from the phase 2b RELIEVE UCCD trial evaluating duvakitug, an investigational anti-TL1A monoclonal antibody co-developed by Teva and Sanofi, in adults with moderate to severely active ulcerative colitis (UC) and Crohn disease (CD).^1,2

Results showed that at week 14, clinical remission rates in UC reached 36% and 48% across the 2 duvakitug dose groups compared with 20% for placebo, and endoscopic response rates in CD reached 26% and 48% compared with 13% for placebo.^1,2

The publications arrive as Sanofi and Teva advance duvakitug into phase 3 development for both indications. Anti-TL1A agents have become a closely watched drug class in inflammatory bowel disease (IBD), with Merck's tulisokibart and Roche's afimkibart also progressing through phase 3 testing in UC and CD.³ Duvakitug's high-dose response rates rank among the strongest posterior remission and response findings reported for the anti-TL1A class to date.^3,4

Assessing Duvakitug in UC and CD: RELIEVE UCCD

RELIEVE UCCD was a multicenter, randomized, double-blind, placebo-controlled phase 2b study enrolling adults 18-75 years of age with moderately to severely active UC or CD, including patients with inadequate response, loss of response, or intolerance to prior conventional or advanced therapies.

Participants were randomly assigned in a 1:1:1 ratio to a 2250 mg subcutaneous loading dose of duvakitug followed by 450 mg or 900 mg every 2 weeks, or matching placebo.

In the UC cohort, investigators screened 260 patients and randomized 137 to the modified intention-to-treat population (47 to 450 mg, 46 to 900 mg, and 44 to placebo). A total of 17 of 47 patients (36%) in the 450 mg group and 22 of 46 (48%) in the 900 mg group achieved clinical remission by modified Mayo score at week 14, compared with 9 of 44 (20%) on placebo. Posterior mean response differences versus placebo were 15% (95% CrI, −3 to 33) for the 450 mg dose and 26% (95% CrI, 8 to 44) for the 900 mg dose, with posterior probabilities of superiority of 0.95 and greater than 0.99, respectively.

In the CD cohort, 139 of 275 screened patients were randomized (46 to 450 mg, 47 to 900 mg, and 46 to placebo); 1 patient in the 900 mg group did not receive study drug, leaving 46 patients per group in the modified intention-to-treat population. 12 of 46 patients (26%) in the 450 mg group and 22 of 46 (48%) in the 900 mg group achieved endoscopic response at week 14, defined as at least a 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease, versus 6 of 46 (13%) on placebo. Posterior probabilities of superiority reached 0.94 for the 450 mg dose and greater than 0.99 for the 900 mg dose.

Patients in the UC cohort had a mean age of 41.0 years (SD, 13.1), and 31% had previous exposure to an approved advanced therapy. Patients in the CD cohort skewed slightly younger (mean age, 39.5 years; SD, 14.7), and 57% had prior advanced therapy exposure, reflecting a more treatment-experienced population entering the CD arm.

Duvakitug Safety Profile in the RELIEVE UCCD Trials

Overall adverse event rates in the UC cohort were similar across arms: 23 of 47 patients (49%) in the 450 mg group, 20 of 46 (43%) in the 900 mg group, and 23 of 44 (52%) on placebo. Anaemia occurred in 1 patient on 450 mg, 1 on 900 mg, and 3 on placebo, while upper respiratory tract infection occurred in 3 patients on 450 mg, 1 on 900 mg, and 1 on placebo. A single serious adverse event occurred in the 900 mg group, non-infective oophoritis, and 1 occurred in the placebo group, intracranial haemorrhage.

In the CD cohort, adverse events were more frequent in the 450 mg group (31 of 46 patients, 67%) than in the 900 mg group (20 of 46, 43%) or placebo (22 of 46, 48%). Nasopharyngitis affected 2 patients on 450 mg, 3 on 900 mg, and 3 on placebo, and headache affected 4 patients on 450 mg, 1 on 900 mg, and 1 on placebo. Serious adverse events occurred in 6 patients (13%) on 450 mg, 1 patient (2%) on 900 mg, and 5 patients (11%) on placebo, with investigators reporting no new safety signals in either cohort.

Duvakitug LTE Data and Future Outlook

Positive results from the RELIEVE UCCD long-term extension (LTE) study were announced on February 17, 2026, and showed durable clinical and endoscopic efficacy maintained over 44 weeks in patients with UC and CD that initially responded to the induction phase, reinforcing the efficacy from the RELIEVE UCCD phase 2b induction study.⁵

“One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it,” Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva, said in a statement at the time of the LTE data announcement.⁵ “These phase 2b results further reinforce TL1A as a compelling target and clearly strengthen the case that duvakitug has the potential to be a best-in-class therapy.”

Duvakitug is now being evaluated in ongoing phase 3 studies for UC and CD under the Teva-Sanofi collaboration, with Sanofi leading clinical development and the companies sharing global development costs and profits. The program advances alongside Merck's tulisokibart and Roche's afimkibart, both competing anti-TL1A candidates in late-stage UC and CD development.

References

1. Efficacy and safety of duvakitug in patients with ulcerative colitis (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. Published online 2026. doi:10.1016/S2468-1253(26)00120-2

2. Efficacy and safety of duvakitug in patients with Crohn's disease (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. Published online 2026. doi:10.1016/S2468-1253(26)00119-6

3. Hillenbrand A. Tulisokibart Meets Phase 3 Endpoints in Ulcerative Colitis, First for Anti-TL1A. HCPLive. June 22, 2026. Accessed July 20, 2026. https://www.hcplive.com/view/tulisokibart-phase-3-endpoints-ulcerative-colitis-anti-tl1a

4. Danese S, Allegretti JR, Schreiber S, et al. Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): a multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2025;10(10):882-895. doi:10.1016/S2468-1253(25)00129-3

5. Sanofi. Sanofi and Teva's duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn's disease. Published February 17, 2026. Accessed July 20, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-17-11-00-00-3239014