Merck has initiated three Phase-2(b) trials evaluating the safety and efficacy of Tulisokibart (MK-7240), an investigational humanised monoclonal antibody targeting Tumour Necrosis Factor (TNF)-like cytokine 1A (TL1A), in patients with three immune-mediated inflammatory diseases. These are MK-7240-12 (NCT06956235) studying patients with moderate to severe Hidradenitis Suppurativa (HS); MK-7240-013 (NCT07133633) studying patients with radiographic axial spondyloarthritis(r-axSpA: also known as ankylosing spondylitis) and MK-7240-014 (NCT07176390) studying patients with Rheumatoid Arthritis (RA).
Global recruitment of these trials has begun, targeting enrollment of more than 640 patients across the three studies.
“The expansion of our Tulisokibart clinical development programme reflects Merck’s ongoing commitment to addressing the burden of immune-mediated inflammatory diseases. We’re excited to further evaluate the potential of Tulisokibart as a treatment for patients across multiple diseases in rheumatology and dermatology,” said Dr Aileen Pangan, Vice President and Head—Immunology, Global Clinical Development, Merck Research Laboratories.
With the initiation of these Phase-2 (b) trials, Tulisokibart is now being investigated in a total of six diseases. Merck is also currently conducting two Phase-3 studies evaluating the efficacy and safety of Tulisokibart in patients with two different types of Inflammatory Bowel Disease (IBD), ATLAS-UC (NCT06052059) in Ulcerative Colitis (UC) and ARES-CD (NCT06430801) in Crohn’s disease (CD), and a Phase-2 study in Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) (NCT05270668).
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