Cure8 research brief
A new biologic (duvakitug) targeting TL1A showed higher clinical remission at 14 weeks than placebo in a phase 2b trial of adults with moderately to severely active ulcerative colitis, which could expand future treatment options if confirmed in later trials.
Adults with ulcerative colitis (including those with prior advanced-therapy exposure), clinicians who treat IBD, and researchers developing new biologic therapies.
This was a multicentre, double-blind, randomised phase 2b trial (NCT05499130) that enrolled adults with moderately to severely active ulcerative colitis, including patients with prior inadequate response or intolerance to advanced therapies. Participants received a loading dose then either 450 mg or 900 mg subcutaneously every 2 weeks, or matched placebo.
The primary endpoint was clinical remission (modified Mayo) at week 14 and analyses used a Bayesian framework; both dosing arms met the prespecified probability threshold for superiority over placebo, with higher remission in the 900 mg group.
Safety appeared broadly similar across arms in this study, with no new safety signals reported in the abstract; common events included anaemia and upper respiratory tract infections, and one serious adverse event in the 900 mg arm. The trial was funded by Teva and Sanofi.
This classification and note are based on the article abstract (phase 2b trial report) published in The Lancet Gastroenterology & Hepatology. Phase 2 findings require confirmation in larger phase 3 trials and regulatory review. The study was funded by industry (Teva and Sanofi).
Review the original publication for the complete reporting, methods, and context.
Conflict statement: Declaration of interests WR has served as a speaker for AbbVie, Celltrion, Ferring, Galapagos, Janssen, Merck Sharp & Dohme, Pfizer, Roche, Sobi, and Takeda; as a consultant for AbbVie, Amgen, AOP Orphan, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Galapagos, Gilead, Index Pharma, Janssen, Medahead, Microbiotica, Pfizer, Takeda, and Teva; served as an advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Janssen, Pfizer, and Teva; and has received research funding from AbbVie, Janssen, Sandoz, Sanofi, and Takeda. RK reports lecture fees from AbbVie, Aboca, Societa Agricola, Eli Lilly, and Ferring; company grant or research support from Johnson & Johnson Innovative Medicine and Takeda; and support for attending meetings or travel from Takeda and Johnson & Johnson. SD reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB, Vial, and Vifor; and lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals, Gilead, Janssen, Mylan, Pfizer, and Takeda. BES reports consulting fees from AbbVie, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, AstraZeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Celltrion, Ensho Therapeutics, Enthera, Enveda Biosciences, Equillium, Evommune, Ferring, Fzata, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Immunyx Therapeutics, Index Pharmaceuticals, Innovation Pharmaceuticals, Kaleido, Kallyope, Merck & Co, Microba, Microbiotica, Mitsubishi Tanabe Pharma, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, Palisade Bio, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biotherapeutics, Sanofi, Sorriso Pharmaceuticals, Surrozen, Target RWE, Teva, TLL Pharmaceutical, TR1X, and Union Therapeutics; consulting and speaking fees from Abivax; consulting and speaking fees and other support from Lilly; research grants, consulting and speaking fees, and other support from Bristol Myers Squibb, Janssen/J & J Innovative Medicine, Pfizer, and Takeda; research grants and consulting fees from Theravance Biopharma; and consulting fees, stock, and stock options from Ventyx Biopharma. BR-D, RS, NG, and KA are Teva employees. PL is a Sanofi employee. HB is a former Teva employee. VJ reports consulting or advisory board fees from AbbVie, Alimentiv, Amgen, Anaptys Bio, Asahi Kasei, Asieris, AstraZeneca, Attovia, Blackbird Labs, BMS, Boehringer Ingelheim, Biomebank, Cabaletta, Caldera, Calluna, Catalytic Health, Celltrion, Ensho, Enthera, Equillium Exeliome Biosciences, Ferring, Fresenius Kabi, Gilead, Granite Bio, GSK, Janssen, Lilly, Merck, Mountainfield, MRM Health, Nxera, Organon, OSE Immunotherapeutics, Palisade Bio, Pendopharm, Pioneering Medicine, Pfizer, Prometheus, Roche/Genentech, Sanofi, SCOPE, Shattuck Labs, Sorriso, Spyre, Synedgen, Takeda, Teva, Throne Scientific, Tillotts, Union Therapeutics, Ventus, Ventyx, Vividion, Xencor, Zealand Pharma; and payment for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Pfizer, Takeda, and Tillotts; and participation on a Data Safety Monitoring Board or Advisory Board for AbbVie, Takeda, Janssen, Fresenius Kabi, Gilead, Roche. All other authors declare no competing interests.
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