tulisokibart (MK-7240) / Merck (MSD) - LARVOL DELTA

Satellite Symposium: Is TNF-Like Ligand 1A (TL1A) Inhibition the Answer to Improving Disease Remission in Inflammatory Bowel Disease? (CCCongress 2026) - "Early studies of investigational anti-TL1A agents—including tulisokibart, afimkibart, and duvakitug—demonstrate encouraging outcomes in patients with moderate-to-severe IBD, showing improvements in symptoms as well as reductions in chronic intestinal inflammation and fibrosis. Through case-based discussions and interactive polling, participants will gain practical, up-to-date strategies to enhance IBD management and remain at the forefront of therapeutic innovation. To Register: https://www.gotoper.com/courses/is-tnf-like-ligand-1a-tl1a-inhibition-the-answer-to-improving-disease-remission-in-inflammatory-bowel-disease"

Clinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Bridging the translational gap: Preclinical efficacy assessment of biologics in humanised mouse models for inflammatory bowel disease (ECCO-IBD 2026) - "Tulisokibart, a monoclonal antibody that targets human TL1A, was given to mice for efficacy assessment...Treatment with human TL1A antibody effectively alleviated the symptoms of colitis in the colitis-bearing mice. These results show our capability of evaluating drug efficacy against IBD, enabling precious opportunities and reducing R&D cycle for drug screening of novel therapeutic candidates, providing translational insights from bench work to clinical trial."

Preclinical • Immunology • Inflammation • Inflammatory Bowel Disease

Sustained symptomatic relief and disease clearance through 50 weeks of treatment with tulisokibart in participants with moderately to severely active ulcerative colitis in the phase 2 ARTEMIS-UC study (ECCO-IBD 2026) - P2 | "Among week 12 responders treated with tulisokibart 250 mg, symptomatic remission and disease clearance were achieved in 68% and 44% of participants, respectively, by 1 year. A phase 3 trial to confirm these findings is ongoing."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • TNFA

Tulisokibart: Primary completion of P3 ATLAS-UC trial (NCT06052059) for ulcerative colitis in Aug 2026 (Merck (MSD), 44th Annual J.P. Morgan Healthcare Conference)

Trial primary completion date • Inflammatory Bowel Disease • Ulcerative Colitis

Tulisokibart: Primary completion of P3 ATLAS-UC trial (NCT06052059) for ulcerative colitis in Aug 2026 (Merck (MSD), 44th Annual J.P. Morgan Healthcare Conference)

Trial primary completion date • Inflammatory Bowel Disease • Ulcerative Colitis

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012) (clinicaltrials.gov) - P2 | N=147 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) (clinicaltrials.gov) - P3 | N=1020 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2029 ➔ Aug 2029 | Trial primary completion date: Nov 2026 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

The TL1A-DR3 axis coordinates antigen presenting cell and IL17+ T cell crosstalk in HS (ISDS 2025) - "Tulisokibart, a monoclonal TL1A blocking antibody, has shown efficacy in Crohn's disease, reducing inflammatory cytokines and Th1 and Th17 pathways, in serum and intestinal biopsies, respectively. Multi-omic data suggests that the TL1A-DR3 axis mediates macrophage/DC crosstalk to T cells and may be involved in pro-inflammatory interactions between tissue cells (KC, fibroblasts) and immunopathogenic immune cells in HS."

Crohn's disease • Dermatology • Gastroenterology • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • CD40 • CD40LG • IL17A • TNFA • TNFRSF25 • TNFSF15

Relationship Between Clinical and Histologic Findings With Tulisokibart Induction at Week 12 and Maintenance Dosing at Week 50 in the Phase 2 Randomized Controlled ARTEMIS-UC Study in Participants With Ulcerative Colitis (ACG 2025) - "There were 65 and 34 tulisokibart participants included in the HAS population for the W12 and W50 analyses, respectively. The strongest correlations were the following: endoscopic improvement:HEMI, endoscopic improvement:mucosal healing, clinical remission:HEMI, and clinical remission:mucosal healing, all >0.8 at W12 (post-induction in Cohort 1) and >0.9 at W50 (post-maintenance dosing in Cohorts 1 and 2). Normalization of fecal calprotectin also demonstrated a strong correlation with histologic endpoints ( >0.7) at W50 (Table). Strong correlations exist between clinical/endoscopic and histologic endpoints after 12 weeks of induction therapy with tulisokibart, followed by 38 weeks of maintenance therapy in induction responders."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

Efficacy and Safety of Tulisokibart Maintenance Treatment in Tulisokibart Induction, Re-induction, and Delayed Induction Responders: Open-Label Extension of the ARTEMIS-UC Trial in Patients With Ulcerative Colitis (ACG 2025) - "In Cohort 1, 47 tulisokibart induction responders, 13 re-induction responders, and 29 delayed induction responders were randomized to OLE maintenance treatment with tulisokibart. Maintenance of treatment effect was generally similar with a trend for higher efficacy with tulisokibart 250 mg vs 100 mg, observed across the 3 groups (Table). The safety profile of tulisokibart maintenance treatment was similar across the 3 groups, with no new safety signals being observed. Tulisokibart was effective as a maintenance treatment in patients with moderately to severely active UC."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

LBL-053, A Novel Anti-TL1A/p40 Bispecific Antibody for the Treatment of Autoimmune Disorders. [WITHDRAWN] (ACR Convergence 2025) - "Ustekinumab, targeting p40 subunit, has demonstrated robust efficacy and approved for IBD...The effect of LBL-053 on inhibiting TL1A-DR3 downstream signaling pathway was comparabile to RVT-3101, but better than MK-7240 and PF-07261271.LBL-053 also significantly blocked IL-23/IL-12Rβ1 interaction... LBL-053 showed dual immunosuppressive functions, simultaneously inhibiting TL1A-DR3 and IL-23/IL-12Rβ1 signaling pathway, indicating promising clinical applications for the treatment of autoimmune diseases."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • CD4 • IFNG • IL12A • IL18 • IL23A • TNFA

A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) (clinicaltrials.gov) - P2 | N=182 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013) (clinicaltrials.gov) - P2 | N=315 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Merck…announced it has initiated three Phase 2b trials evaluating the safety and efficacy of tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in patients with three immune-mediated inflammatory diseases: (Merck (MSD) Press Release) - "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); MK-7240-014 ( NCT07176390) studying patients with rheumatoid arthritis(RA)"

Trial status • Hidradenitis Suppurativa • Rheumatoid Arthritis • Spondylarthritis

RELATIONSHIP BETWEEN CLINICAL AND HISTOLOGIC FINDINGS WITH TULISOKIBART INDUCTION AT WEEK 12 AND MAINTENANCE DOSING AT WEEK 50 IN THE PHASE 2 RANDOMIZED CONTROLLED ARTEMIS-UC STUDY IN PARTICIPANTS WITH ULCERATIVE COLITIS (UEGW 2025) - "Strong correlations exist between clinical, endoscopic, and histologic endpoints after 12 weeks of induction therapy with tulisokibart, followed by 38 weeks of maintenance therapy in induction responders. These findings underscore the potential for clinical remission to reflect both endoscopic and histologic healing in UC patients, which may enhance patient management strategies and enable a more comprehensive understanding of treatment efficacy. Moreover, these findings indicate the potential of tulisokibart in achieving deep remission2 in patients with ulcerative colitis."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

EFFICACY AND SAFETY OF TULISOKIBART MAINTENANCE TREATMENT IN TULISOKIBART INDUCTION RESPONDERS VERSUS TULISOKIBART RE-INDUCTION AND DELAYED INDUCTION RESPONDERS: RESULTS FROM THE OPEN-LABEL EXTENSION OF THE PHASE 2 ARTEMIS-UC TRIAL IN PATIENTS WITH ULCERATIVE COLITIS (UEGW 2025) - "Tulisokibart was effective as a maintenance treatment in patients with moderate to severe UC. The effect was generally similar across Cohort 1 tulisokibart induction responders, re-induction responders, and delayed induction responders. Tulisokibart maintenance treatment was well tolerated across the 3 groups, with no identified safety signals."

Clinical • P2 data • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • TNFA

TL1a, Inflammatory and Fibrotic Pathways Are Upregulated in Hidradenitis Suppurativa (EADV 2025) - "Tulisokibart, a monoclonal TL1a blocking antibody, and other anti-TL1A blocking antibodies have shown efficacy in IBD including Crohn's disease which, like HS, exhibits granulomatous features, and have shown to reduce Th1 and Th17 pathways in the tissue... TL1A expression, pathway and network activity analysis suggests that TL1A may modulate immune and fibrotic pathways in HS skin. Data supports targeting TL1a as a potential effective therapy in HS."

Crohn's disease • Dermatology • Fibrosis • Gastroenterology • Hidradenitis Suppurativa • Immunology • Inflammatory Bowel Disease • CD40 • CD40LG • IFNG • IL17A • IL1B • IL1R1 • IL6 • KLRB1 • TNFA • TNFRSF25 • TNFSF15

A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) (clinicaltrials.gov) - P2 | N=182 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Long-term efficacy and safety of tulisokibart in participants with ulcerative colitis: the open-label extension of the phase 2 ARTEMIS-UC study (BSG 2025) - P2 | "A trend for higher efficacy with tulisokibart 250 mg vs 100 mg maintenance treatment was observed at week 50. Tulisokibart was well tolerated with no identified safety signals."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • TNFA

ARTEMIS-UC: A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005) (clinicaltrials.gov) - P2 | N=178 | Completed | Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Jul 2025

Trial completion • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and safety results of tulisokibart re-induction treatment in participants with ulcerative colitis in the phase 2 ARTEMIS-UC clinical trial (BSG 2025) - "Re-induction with tulisokibart was well tolerated with no serious AEs or discontinuations due to AEs and no new safety signals.Conclusions Re-induction treatment with tulisokibart is effective in participants who did not respond to initial induction treatment. Additionally, up to two tulisokibart induction regimens of 24 weeks is well tolerated with no new safety signals identified."

Clinical • P2 data • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • TNFA

A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013) (clinicaltrials.gov) - P2 | N=315 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P2 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

APOLLO-CD: A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=55 | Completed | Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ May 2025

Trial completion • Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012) (clinicaltrials.gov) - P2 | N=147 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

Comparative Efficacy of Different Targeted Therapies in Patients With Moderate-to-Severe Ulcerative Colitis: Systematic Review/Network Meta-Analysis and Mechanistic Overview. (PubMed, Pharmacol Res Perspect) - "Cobitolimod 250 mg was the first-ranked treatment (SUCRA, 92.67%) in Endoscopic remission. Vedolizumab 108 mg was the best dosage in reducing Adverse Events (AEs). The optimal dosage for reducing Serious Adverse Events (SAEs) was found to be Tulisokibart 1000/500 mg. During the maintenance phase, Etrasimod 2 mg/kg ranked first in clinical remission (OR 9.58; 95% CI, 2.82-32.59), and Upadacitinib 45 mg was superior in endoscopic remission. Additionally, the most effective medication for raising quality of life was Guselkumab 200 mg (OR 3.04; 95% CI, 1.70-5.40). Consequently, there is a need for further high-quality research to conclusively determine the best therapeutic option."

Clinical • Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis