Phase 2b RELIEVE UCCD trial highlights duvakitug anti-TL1A antibody improving endoscopic response in adults with moderately to severely active Crohn’s disease.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
Duvakitug, an investigational anti-TL1A monoclonal antibody developed by Teva and Sanofi, significantly improved endoscopic outcomes in adults with moderately to severely active Crohn’s disease in the Phase 2b RELIEVE UCCD study. The results were published in The Lancet Gastroenterology & Hepatology, providing peer-reviewed evidence that supports the continued clinical development of the therapy as a potential treatment option for patients with difficult-to-treat inflammatory bowel disease.
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that often progresses despite treatment with biologics and other advanced therapies. Many patients continue to experience persistent inflammation, highlighting the need for therapies that target alternative immune pathways beyond tumor necrosis factor (TNF).
Duvakitug Targets the TL1A Pathway
Duvakitug is a human monoclonal antibody that blocks tumor necrosis factor-like cytokine 1A (TL1A), an inflammatory signaling protein implicated in intestinal inflammation and tissue fibrosis. By inhibiting this pathway, the therapy aims to reduce intestinal inflammation and promote mucosal healing in patients with Crohn’s disease.
More than half of the patients enrolled in the study had previously received at least one advanced therapy, reflecting a population with substantial unmet medical need.
Phase 2b Trial Met Primary Endpoint
The multicenter, randomized, placebo-controlled Phase 2b study (NCT05499130) enrolled adults aged 18 to 75 years with moderately to severely active Crohn’s disease who had experienced inadequate response, loss of response, or intolerance to prior therapies.
A total of 139 participants were randomized to receive a 2,250 mg loading dose followed by subcutaneous duvakitug 450 mg or 900 mg every two weeks, or placebo. The modified intention-to-treat analysis included 138 treated patients.
The primary endpoint was endoscopic response at Week 14, defined as at least a 50% reduction from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD).
The higher 900 mg dose produced the strongest efficacy signal. Endoscopic response occurred in 48% of patients receiving 900 mg compared with 13% in the placebo group. The Bayesian analysis showed a 33% higher posterior mean response rate versus placebo, with a posterior probability of superiority exceeding 99%.
The 450 mg dose also met the predefined success criterion. Endoscopic response was observed in 26% of patients, corresponding to a 13% higher posterior mean response rate than placebo and a posterior probability of superiority of 94%.
Favorable Safety Profile
Duvakitug demonstrated a safety profile consistent with previous studies, with no new safety concerns identified.
Adverse events occurred in 67% of patients receiving the 450 mg dose, 43% receiving the 900 mg dose, and 48% receiving placebo. The most commonly reported adverse events were nasopharyngitis and headache.
Serious adverse events were reported in 13% of patients in the 450 mg group, 2% in the 900 mg group, and 11% in the placebo group, suggesting no increase in serious safety events with the higher dose.
Publication Strengthens Evidence for TL1A Inhibition
The peer-reviewed publication in The Lancet Gastroenterology & Hepatology adds independent scientific validation to the Phase 2b findings and strengthens the evidence supporting TL1A inhibition as a therapeutic strategy for inflammatory bowel disease. The robust endoscopic responses observed with duvakitug, particularly at the 900 mg dose, indicate meaningful control of intestinal inflammation in a patient population that included a high proportion of individuals previously exposed to advanced therapies.
The Phase 2b results support continued clinical development of duvakitug as Teva and Sanofi evaluate its potential role in the evolving treatment landscape for Crohn’s disease. Longer-term studies will be important to determine whether the early improvements in endoscopic healing translate into sustained clinical remission, reduced disease progression, and durable safety over extended treatment periods.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.