Holon

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

This clinical trial is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics PK of OMN6 in patients with hospital-acquired bacterial pneumonia HABP or ventilator-associated bacterial pneumonia VABP caused by the Acinetobacter baumannii complex ABC. The purpose is to identify safe and well-tolerated doses of OMN6 and understand its behavior in the body when added to standard therapies. Participants receive either OMN6 or a placebo alongside background antibiotic treatment with meropenem and colistin. OMN6 is given in three dosing cohorts 50 mg, 100 mg, or 150 mg, each administered as three 3-hour intravenous infusions on a single day, while meropenem plus colistin treatment continues for 7 to 14 days. The comparator group receives matching placebo infusions under the same schedule plus the background antibiotics. Throughout the study, participants are closely monitored for safety and the pharmacokinetics of OMN6, including measures such as maximum concentration, time to maximum concentration, area under the curve, and half-life. Safety assessments focus on the 28 days following the single-day infusion. The trial includes randomized assignment and double-blinding to ensure unbiased evaluation. The total study duration extends until primary completion in March 2027.

Researchers are evaluating the experimental antibody COM701 to see if it can delay the progression of relapsed platinum sensitive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The trial aims to find out if COM701, given as maintenance treatment, can slow disease progression, delay the need for new anti-cancer treatments, and to understand its safety profile in participants who have had prior platinum-containing therapies. This trial is a randomized, double-blind, placebo-controlled study where participants have a 67% chance to receive COM701 and a 33% chance to receive a placebo. The treatment is given through intravenous infusion once every three weeks. The study includes multiple sub-studies, with initial focus on COM701 alone and later evaluation of COM701 combined with other anti-cancer drugs as maintenance therapy. Participants will visit the clinic every three weeks for treatment infusion and undergo various health checks including physical exams, vital signs, ECG, blood and urine tests, and pregnancy tests if applicable. Disease response is monitored through tumor imaging by CT or MRI scans and analysis of tumor tissue samples. The main outcome is progression-free survival over up to two years, with safety monitored during and up to 90 days after treatment. The study duration and follow-up depend on individual participant progress.

Researchers are evaluating the safety and effects of a medicine called fosmanogepix for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida yeast. This Phase 3 clinical trial compares fosmanogepix to the standard treatment using caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard treatment by a margin of 15%. The study includes adult patients diagnosed with these infections and is sponsored by Basilea Pharmaceutica. Participants are randomly assigned to one of two groups two-thirds receive fosmanogepix intravenously, with an option to switch to oral tablets, while one-third receive caspofungin intravenously followed by oral fluconazole. Matching placebos are given to maintain blinding. Treatments are given daily, first by IV infusion at the clinic and then orally either at the clinic or at home if discharged. Treatment duration can be up to six weeks, depending on infection clearance and symptom improvement. Participants will be monitored through multiple study visits, with assessments including survival status at 30 days, treatment success at the end of treatment, and follow-up evaluations six weeks after stopping treatment. Additional evaluations include clinical and mycological responses, blood cultures, safety monitoring such as adverse events, lab tests, neurological exams, ECGs, and drug concentration measurements. The total study duration for each participant may be approximately 12.5 weeks, considering treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

Researchers are evaluating how well JNJ-78934804 works and how safe it is compared to guselkumab in participants with moderately to severely active Crohns disease, a long-term and progressive condition affecting the intestine. This Phase 3 trial aims to assess clinical remission and endoscopic remission at Week 48, focusing on treatment efficacy and safety. Participants are randomly assigned to receive either JNJ-78934804 or guselkumab. Both treatments involve induction doses at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting at Week 12. Participants meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, with maintenance doses continuing every 4 weeks from Week 28. Those completing the double-blind phase at Week 48 may enter a long-term extension phase if the investigator believes they may benefit. During the study, participants will be monitored for clinical and endoscopic remission, deep remission, corticosteroid-free remission, and patient-reported outcomes up to Week 48. Researchers will also track adverse events for up to approximately three years. Assessments include symptom scores, endoscopy reviews, and quality-of-life questionnaires to evaluate the treatments effects and safety throughout the trial.

Researchers are evaluating the effectiveness and safety of JNJ-78934804 compared to guselkumab in people with moderately to severely active ulcerative colitis UC, a chronic condition where the colon lining becomes inflamed and develops ulcers. This Phase 3 study aims to measure clinical remission and other health improvements by Week 48. Participants receive an induction dose of either JNJ-78934804 or guselkumab at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting Week 12. Those meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, then maintenance doses every 4 weeks from Week 28. After completing the 48-week double-blind treatment phase, participants benefiting from the intervention may join a long-term extension phase. Throughout the study, participants will be monitored for clinical remission, endoscopic improvement, corticosteroid-free remission, fatigue, abdominal pain, quality of life, and mental health responses. Safety is assessed by tracking adverse events up to about 3 years. The study involves randomized assignment and double-blinding, with all treatments given by subcutaneous injection. Participation may last up to several years including follow-up and extension phases.