Monroe

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). The study aims to assess how well duvakitug maintains clinical remission compared to a placebo over time. Participants will receive either duvakitug or placebo administered by subcutaneous injection during a 40-week pivotal maintenance period. Following this, eligible participants may join a 240-week open-label extension phase where they can continue receiving treatment. Participants who do not join the extension will complete a 45-day follow-up visit. The study includes up to 32 on-site visits, with 21 visits during the maintenance phase and 11 visits during the extension phase. Throughout the study, participants will be monitored for clinical remission using the modified Mayo Score by week 40. Safety and efficacy will be assessed regularly during office visits. The total study duration may last up to 286 weeks, including treatment, extension, and follow-up periods, ensuring thorough evaluation of long-term outcomes and safety of duvakitug in UC management.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effects of ECC4703, a thyroid hormone receptor beta isoform agonist, and ECC0509, a semicarbazide sensitive amine oxidase inhibitor, alone and combined, on reducing liver fat in adults with presumed metabolic dysfunction-associated steatohepatitis (MASH). This Phase 2a trial aims to measure changes in liver fat using magnetic resonance imaging proton density fat fraction (MRI-PDFF) after 12 weeks of treatment. Participants are randomly assigned to receive low or high doses of ECC4703, ECC0509, their combination, or placebo in oral capsule form. The study compares the dose-dependent effects of these treatments on hepatic fat reduction. Placebo capsules match the active treatments to maintain blinding. The treatment period lasts for 12 weeks. During the study, participants undergo MRI scans to measure liver fat content at baseline and week 12. Researchers monitor liver enzymes, metabolic markers, and safety throughout the trial. Participants must comply with study procedures, including regular assessments and biomarker tests, to evaluate the efficacy and safety of the treatments over the 12-week period.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo for reducing body weight in adults who have overweight or obesity along with type 2 diabetes. This Phase 3, randomized, double-blind study focuses on participants who have been on stable treatment for their type 2 diabetes and aims to provide detailed information on body weight changes over time. Participants will receive either eloralintide or a placebo administered by subcutaneous injection once weekly. The study lasts about 75 weeks, including treatment and follow-up periods. The goal is to monitor the changes in body weight from the beginning of the study through week 64. During the study, participants will undergo various assessments to track body weight and overall health. Researchers will collect data on weight changes and monitor safety throughout the study period. The main outcome measured is the percentage change in body weight from baseline to week 64, ensuring close observation of participants' responses to the treatment.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease. The study includes three sub-studies focusing on induction treatment, with specific co-primary endpoints assessing clinical remission and endoscopic response at 12 weeks. Participants will receive either duvakitug or a placebo via subcutaneous injection during the treatment periods. The study duration can last up to 35 weeks and consists of a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 (open-label feeder induction) or Sub-Study 2 (pivotal induction). Non-responders may enter a 12-week extended induction phase in Sub-Study 3. After treatment, participants not enrolling in the maintenance study will have a 6-week follow-up period. Throughout the study, participants will have scheduled visits for assessments, including monitoring of clinical remission and endoscopic response using standardized scoring systems at 12 weeks. The total number of visits varies depending on sub-study participation, with up to 15 visits for those in Sub-Study 3. Safety and treatment effects will be closely monitored during these visits and follow-up periods.

Researchers are evaluating the safety and effectiveness of duvakitug in people with moderately to severely active Ulcerative Colitis (UC). This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to see if duvakitug can help achieve clinical remission in this condition. The study targets participants aged 16 to 80 years with a confirmed diagnosis of active UC for at least 3 months who have not responded well or are intolerant to other treatments. Participants will receive either duvakitug or a placebo as a solution injected under the skin (subcutaneous injection). The study includes up to 35 weeks with multiple periods: a screening period, a 12-week induction phase (either open-label or randomized), a 12-week extended induction for those who do not respond initially, and a 45-day follow-up for those not continuing into the maintenance study. During these phases, participants may have up to 8 to 15 on-site visits depending on their sub-study group. Throughout the study, participants will be monitored closely with scheduled visits for assessments including clinical evaluations related to UC activity and response to treatment. The main outcome measured is the proportion of participants who achieve clinical remission by week 12. Safety and tolerability will also be tracked during and after the treatment period, with follow-up visits to ensure participant well-being.