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

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

Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial. (PubMed, Lancet Gastroenterol Hepatol) - P2 | "This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well tolerated. Randomised controlled trials with longer duration are needed to confirm these results; a double-blind, placebo-controlled, phase 3 trial is currently underway."

Journal • P2a data • Crohn's disease • Fatigue • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Nephrology • Novel Coronavirus Disease

Tulisokibart shows promise for Crohn's disease. (PubMed, Lancet Gastroenterol Hepatol) - No abstract available

Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

AI-GUIDED DESIGN AND DEVELOPMENT OF HXN-1001: A POTENT, HALF-LIFE-EXTENDED ANTI-TL1A ANTIBODY (DDW 2025) - "In a DSS-induced colitis model using hTL1A, hTL1A/hα4β7, or hTL1A/hIL23 transgenic mice, HXN-1001 provided enhanced anti-inflammatory effects compared to RVT-3101, MK-7240, and the α4β7 integrin-targeting antibody Vedolizumab. In addition, in an imiquimod (IMQ)-induced psoriasis model, HXN-1001 outperformed the marketed anti-IL23 monoclonal antibody Risankizumab in reducing psoriatic-like inflammation, suggesting its utility in broader immune-mediated conditions...The preclinical data collectively establish HXN-1001 as a promising therapeutic candidate with broad immunomodulatory capabilities, superior efficacy compared to current standards, and an extended dosing profile suited for chronic inflammatory and autoimmune diseases. HXN-1001 is anticipated to enter clinical development in Q2 2025."

Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Rheumatology • Ulcerative Colitis • CD40LG • IFNG • TNFSF15

INFECTION ADVERSE EVENTS WITH TULISOKIBART OVER 50 WEEKS OF TREATMENT IN THE PHASE 2 CROHN'S DISEASE APOLLO-CD TRIAL (DDW 2025) - "Tulisokibart treatment over the 12-week induction demonstrated low incidence of serious infection AEs and no apparent increased risk of infection AEs compared with biologic treatments for CD in prior clinical trials. No new infection safety signals appeared in the OLE. All infection AEs resolved, most were considered nonserious and mild to moderate in severity, and no participants discontinued treatment due to an infection AE."

Adverse events • P2 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Nephrology • Novel Coronavirus Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • TNFA

LONG-TERM EFFICACY AND SAFETY OF INTRAVENOUS TULISOKIBART IN PATIENTS WITH CROHN'S DISEASE: RESULTS FROM THE OPEN-LABEL EXTENSION PERIOD OF THE PHASE 2 APOLLO-CD STUDY (DDW 2025) - "At week 50, maintenance of treatment efficacy was reported in 12-week induction responders, with dose response observed. Tulisokibart was well tolerated with no safety signals identified through 50 weeks of treatment. A phase 3 trial in a larger patient population has been initiated to confirm these findings."

Clinical • P2 data • Crohn's disease • Fibrosis • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Influenza • Nephrology • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Respiratory Diseases • CRP • TNFA