Merck Initiates Three Phase 2b Trials Of Tulisokibart (MK-7240) In Inflammatory Diseases

Merck, known as MSD outside the United States and Canada, announced the initiation of three Phase 2b clinical trials to evaluate the safety and efficacy of tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor (TNF)-like cytokine 1A (TL1A). The studies will assess tulisokibart in patients with hidradenitis suppurativa (HS), radiographic axial spondyloarthritis (r-axSpA; ankylosing spondylitis), and rheumatoid arthritis (RA).

The trials include MK-7240-012 (NCT06956235) for moderate to severe HS, MK-7240-013 (NCT07133633) for r-axSpA, and MK-7240-014 (NCT07176390) for RA. Global patient recruitment is underway, with plans to enroll over 640 participants across the three studies.

“The expansion of our tulisokibart clinical development program 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 of immunology, global clinical development, Merck Research Laboratories. 

With these new Phase 2b trials, tulisokibart is now being evaluated in six immune-mediated inflammatory diseases. In addition to these programs, Merck is conducting two Phase 3 trials — 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).