Duvakitug – Phase IIb Trial
Architecture
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Randomized, placebo-controlled Phase IIb study assessing duvakitug, another anti-TL1A monoclonal antibody, in moderate-to-severe UC and Crohn’s disease.
Location
US, EU, Israel
Category
Hudson Yards, New York
Year
2024
Duvakitug’s Phase IIb trial focused on patients with moderate-to-severe inflammatory bowel disease (IBD), including both ulcerative colitis and Crohn’s disease populations. Conducted at sites across the US, Europe, and Israel, the study randomized participants to receive varying doses of duvakitug or placebo over 14 weeks. The primary objective was to evaluate clinical remission rates alongside secondary endpoints such as endoscopic improvement, histologic remission, and patient-reported quality of life.
The results showed a dose-dependent response, with high-dose duvakitug achieving clinical remission in nearly half the treated UC patients, a significant improvement over placebo. Parallel improvements were noted in Crohn’s disease cohorts, underscoring the drug’s broad anti-inflammatory potential. Safety data reinforced its favorable profile; adverse events were generally mild to moderate, including fatigue and headache, with no unexpected signals.
In addition to clinical endpoints, the trial explored immunologic biomarkers, such as reductions in pro-inflammatory cytokines and modulation of gut immune cell populations. These data elucidate the mechanisms underlying duvakitug’s efficacy and help identify responder profiles. The dual benefit in both UC and Crohn’s aligns with the growing recognition of shared inflammatory pathways in these diseases.
With positive Phase IIb results, duvakitug is advancing toward Phase III development, backed by a strategic partnership between Sanofi and Teva. This program represents a substantial investment aiming to address unmet needs in IBD management, particularly for patients who have failed existing therapies. The oral administration route enhances patient convenience, potentially improving adherence compared to injectable biologics.
