MK-7240 for Ulcerative Colitis
Palo Alto (17 mi)Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Merck Sharp & Dohme LLC
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing tulisokibart, a new medication, to see if it can help people with moderately to severely active ulcerative colitis. The goal is to determine if tulisokibart can reduce inflammation and heal sores in the colon, leading to fewer symptoms. The study will compare different doses of tulisokibart over several months.
What safety data exists for MK-7240 in treating ulcerative colitis?The provided research does not contain specific safety data for MK-7240, Tulisokibart, or any other name associated with this treatment for ulcerative colitis. The studies focus on other biologic drugs, anti-inflammatory agents, and treatments like tofacitinib, but none mention MK-7240 or its variants.12567
What data supports the idea that the drug MK-7240 for Ulcerative Colitis is an effective treatment?The available research shows that mirikizumab, which is another name for MK-7240, is effective in treating moderate to severe ulcerative colitis. It has been shown to help patients who did not respond to other treatments, including biological therapies and tofacitinib. Mirikizumab works by targeting a specific part of the immune system involved in ulcerative colitis, and it has been approved in Europe for this use. Additionally, it has a good safety profile and has been effective in reducing symptoms like bowel urgency, which improves patients' quality of life.4561011
Is the drug MK-7240 a promising treatment for ulcerative colitis?The drug MK-7240, also known as Tulisokibart, is considered promising for treating ulcerative colitis because it targets the IL-23 pathway, which plays a key role in the disease. This approach has shown success in other treatments, suggesting MK-7240 could be effective in managing symptoms and inflammation in ulcerative colitis.34589
Do I need to stop my current medications for this trial?The protocol does not specify if you need to stop your current medications. However, you must be on stable doses of any protocol-specified drugs during the study and meet drug stabilization requirements. If you are on UC-related antibiotics, you need to be on stable doses for at least 14 days before randomization or have discontinued them within 14 days of randomization.
Eligibility Criteria
This trial is for people with moderate to severe ulcerative colitis who've had symptoms for at least 3 months, weigh over 40 kg, and haven't responded well to certain treatments. Participants must be adults or adolescents approved by local authorities, use contraception if they can have children, and not be pregnant or breastfeeding.Treatment Details
The study tests Tulisokibart's effectiveness in achieving clinical remission of ulcerative colitis at weeks 12 and 52 compared to a placebo. It involves two forms of administration: subcutaneous (SC) injections and intravenous (IV) infusions.
11Treatment groups
Experimental Treatment
Placebo Group
Group I: Study 2: Low Dose InductionExperimental Treatment1 Intervention
Participants receive low dose IV tulisokibart.
Group II: Study 2: Low Dose ExtensionExperimental Treatment2 Interventions
Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Group III: Study 2: High Dose InductionExperimental Treatment1 Intervention
Participants receive high dose IV tulisokibart.
Group IV: Study 2: High Dose ExtensionExperimental Treatment1 Intervention
Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Group V: Study 1: Low Dose Induction, Low Dose MaintenanceExperimental Treatment3 Interventions
Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Group VI: Study 1: Low Dose ExtensionExperimental Treatment2 Interventions
Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Group VII: Study 1: High Dose Induction, Low Dose MaintenanceExperimental Treatment3 Interventions
Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Group VIII: Study 1: High Dose Induction, High Dose MaintenanceExperimental Treatment2 Interventions
Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Group IX: Study 1: High Dose ExtensionExperimental Treatment1 Intervention
Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Group X: Study 2: PlaceboPlacebo Group3 Interventions
Participants receive IV placebo.
Group XI: Study 1: PlaceboPlacebo Group3 Interventions
Participants receive IV placebo, followed by an SC placebo regimen.
Find a clinic near you
Research locations nearbySelect from list below to view details:
GI Alliance: Mansfield ( Site 0161)Mansfield, TX
Clinnova Research - Orange ( Site 3803)Orange, CA
GI Alliance - San Marcos ( Site 0130)San Marcos, TX
New York Gastroenterology Associates ( Site 0159)New York, NY
More Trial Locations
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Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
PPD, Part of Thermo Fisher ScientificIndustry Sponsor
References
Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis. [2018]We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC).
[Anti-inflammatory effect of recombinant human kallistatin in ulcerative colitis of mice]. [2018]This study was designed to evaluate the anti-inflammatory effect of recombinant human kallistatin (Kal) on ulcerative colitis (UC) in the mouse model. Acute colitis was induced by administration of 4% dextran sodium suffate (DSS) to KM mice for 7 days. The mice were then randomized into 5 groups: model control, Kal 0.2 mg·kg(-1)·d(-1), 1.0 mg·kg(-1)·d(-1) and 2.0 mg·kg-1·d(-1) group, salazosulfapyridine (SASP) group. Ten age-matched normal KM mouse were administered with saline in the normal control. The weight, colon length, inflammation factor (MPO/SOD/MDA) and TNF-α/IL-10 levels among the five groups of mice were determined. The results showed that histological index score and MPO/MDA/TNF-α levels of high-dose Kal treatment group and SASP group were significantly lower compared with the model group (P
Efficacy of tofacitinib treatment in ulcerative colitis. [2019]Tofacitinib is an oral synthetic small-molecule inhibitor of Janus kinases, which are involved in the pathogenesis of various inflammatory diseases, representing a new therapeutic option for ulcerative colitis. The efficacy and safety of tofacitinib have been demonstrated in clinical trials in patients with moderate to severe ulcerative colitis, and it has recently been approved by the European Medicines Agency to treat this disease. This article reviews the most relevant characteristics of tofacitinib, its main differences from biological agents, the studies which demonstrate its efficacy in patients with ulcerative colitis, and its optimal use in different clinical situations.
Rapid Induction and Maintenance of Remission in Refractory Ulcerative Colitis with Ustekinumab. [2020]Ulcerative colitis is a chronic debilitating disease characterized by relapsing in intestinal inflammation and ulcers with no available cure. This is a clinical case report of a 52-year-old female patient with 30 years history of left-sided chronic ulcerative colitis controlled with standard of care (mesalamine and azathioprine) which subsequently relapsed and developed into active refractory ulcerative colitis. The patient became unresponsive to her medications including different forms of mesalamines and did not respond favorably to any of the other current therapies. Numerous attempts to stabilize her condition with immunosuppressants, steroids, probiotics, antibiotics, mesalamines, and various biologic agents failed to improve her clinical symptoms, and the patient was being considered for colectomy. As the last resort, modified therapy was prescribed with ustekinumab, a non-selective, anti-IL12/23 p40 monoclonal antibody. This medication has not been yet approved for use in ulcerative colitis patients. In this clinical case we report the efficacy of ustekinumab to rapidly induce and maintain remission of the severe chronic ulcerative colitis in the patient. To the best of our knowledge, this is the first report of utilizing ustakinamub therapy for rapid induction in an active refractory ulcerative colitis patient resulting in complete remission for over one year.
Anti-interleukin-23 agents for the treatment of ulcerative colitis. [2020]Introduction: Treatment of ulcerative colitis (UC) aims to control symptoms and to suppress intestinal inflammation. Despite considerable advances, a proportion of patients do not respond to currently available drugs. The interleukin (IL)-23 axis plays a significant role in the pathogenesis of UC and has thus become an important target for drug development.Areas covered: The review briefly summarizes the pathophysiology of the IL-12/23 axis and provides a synopsis of the available evidence for efficacy and safety of ustekinumab, mirikizumab (LY3074828), risankizumab (BI655066/ABBV066), brazikumab (MEDI2070; formerly AMG139) and guselkumab (CNTO1959) in UC. We also provide an overview of ongoing and anticipated trials in this field.Expert opinion: A Phase 2 trial with mirikizumab and a Phase 3 trial with ustekinumab have demonstrated the efficacy of anti-IL-23 agents in achieving clinical and endoscopic outcomes in UC with a favorable safety profile. Trials of other anti-IL-23 agents in UC are under way and designed to explore head-to-head efficacy with existing biologics, as well as the prospect of combination biological therapy. Apart from data on longer term efficacy and safety, future trials should also explore strategies to inform the positioning of IL-23 antagonists in therapeutic algorithms.
Profile of Tofacitinib in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Recent Data. [2023]Recent advances in the understanding of the pathophysiology of ulcerative colitis (UC) have led to the expansion of our therapeutic arsenal. Conventional treatment options, including aminosalicylates, corticosteroids, thiopurines, and calcineurin inhibitors, fail to control the disease in a significant proportion of patients. Approximately 25-50% of the patients treated with tumor necrosis factor antibodies (anti-TNFα) are primary and secondary non-responders to therapy. Tofacitinib is a novel orally administered small synthetic molecule that inhibits a homologous family of enzymes, termed Janus kinases that modulate multiple key cytokines involved in the pathogenesis of UC. Phase II and III trials showed promising results in UC, leading the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to approve its administration for the induction and maintenance of remission in moderate-to-severe UC. Herein, we review tofacitinib for the management of UC, its mechanism of action pharmacokinetic properties, efficacy, and safety.
Real-World Effectiveness and Safety of Tofacitinib in Patients With Ulcerative Colitis: Systematic Review With Meta-Analysis. [2022]Knowledge of the real-world effectiveness and safety of tofacitinib for ulcerative colitis (UC) is relevant to confirm the benefit observed in clinical trials.
Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1 of Induction Treatment. [2023]We evaluated the efficacy of once-daily (QD) upadacitinib 45 mg, an oral, reversible Janus kinase inhibitor, on early symptomatic improvement for ulcerative colitis (UC). Post hoc analyses were performed on pooled data from 2 replicate, phase 3, multicenter induction trials, U-ACHIEVE Induction and U-ACCOMPLISH, to determine the earliest time point of efficacy onset.
Effectiveness and Safety of Tofacitinib in the Management of Ulcerative Colitis: A Brazilian Observational Multicentric Study. [2023]Ulcerative colitis (UC) is a chronic inflammatory bowel disease which affects the colorectal mucosa with a relapsing-remitting pattern. The therapeutic options currently available for the medical management of UC include many options. Tofacitinib is an oral small molecule, Janus kinase (JAK) inhibitor, more selective for JAK1 and JAK3, which reduces the inflammatory process involved in the pathogenesis of UC.
Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. [2023]Bowel urgency reduces ulcerative colitis patients' quality of life. Mirikizumab, a p19-directed anti-IL-23 antibody, demonstrates ulcerative colitis efficacy. Mirikizumab efficacy to reduce bowel urgency and bowel urgency association with other endpoints were analyzed in 2 Phase 3 trials.
Mirikizumab for the treatment of moderate to severe ulcerative colitis. [2023]Despite a growing number of available therapeutic options for ulcerative colitis (UC), up to 50% of patients do not respond to initial treatment or lose response over time, highlighting the need for novel therapies. The IL-23 pathway has emerged as an important therapeutic target for UC. Mirikizumab is a humanized IgG4 monoclonal antibody against the p19 subunit of IL-23, dosed intravenously during induction and subcutaneously during maintenance. It is effective for the induction and maintenance of remission in moderately to severely active UC, including patients with prior failure of biological or tofacitinib therapy. Like other IL-23 antagonists, mirikizumab has a favorable safety profile. It is the first agent of its class to receive regulatory approval for moderately to severely active UC in Europe.