New Lambton Heights

Researchers are evaluating sotatercept as a potential treatment for pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and overworking the heart. PAH symptoms include difficulty breathing and reduced ability to be active. Current standard treatments address symptoms but do not stop disease progression. This Phase 3 study focuses on the long-term safety and tolerability of sotatercept when added to standard PAH therapy. Participants in this long-term follow-up study receive sotatercept through subcutaneous injections every three weeks. Only individuals who completed prior sotatercept PAH studies without early discontinuation may join. This study continues the observation and assessment of participants over an extended period to learn about the effects and safety of sotatercept combined with background PAH treatments. During the study, participants will be regularly monitored for adverse events, treatment discontinuations, and the presence of anti-drug antibodies for up to approximately 90 months. Laboratory tests will evaluate blood components such as platelets, hemoglobin, creatinine, bilirubin, and liver enzymes. Changes from baseline in body weight, blood pressure, and electrocardiogram readings will also be tracked. The study involves adherence to visit schedules and compliance with study procedures to ensure comprehensive long-term safety data collection.

Researchers are evaluating the safety and tolerability of DB-1311/BNT324 in adults with advanced or metastatic solid tumors in this Phase 1/2a trial. The study includes a dose-escalation phase to find the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase to confirm safety and explore effectiveness, including in prostate cancer patients receiving novel hormone therapy. Additionally, a sub-study will assess the effects of other drugs on DB-1311's behavior in the body. During Phase 1, participants receive increasing doses of DB-1311 administered intravenously using an accelerated titration and classic 3+3 design to determine safe dosage levels. Phase 2a expands on this to further evaluate safety and tolerability, with DB-1311 given alone or combined with hormone therapy drugs such as enzalutamide or abiraterone for prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Treatment schedules and dosing details follow the study protocol at multiple centers. Participants will undergo various assessments including safety labs, vital signs, electrocardiograms, heart function tests, and performance status evaluations up to approximately one year after treatment. Researchers will monitor treatment-related toxicities, serious adverse events, and response rates. The involvement includes tumor biopsies for biomarker analysis and adherence to follow-up visits. The total study duration varies by phase, with ongoing safety and efficacy monitoring throughout.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are investigating the effects of low-dose intracoronary thrombolytic therapy in patients who experience ST-elevation myocardial infarction (STEMI), a type of heart attack caused by a blood clot blocking the heart's blood vessels. The study focuses on patients with impaired microcirculatory perfusion, identified by an elevated Index of Microcirculatory Resistance (IMR) after angioplasty. This damage to the heart's small vessels is linked to worse clinical outcomes, and the trial seeks to determine if dissolving clots inside the coronary artery can reduce this damage and improve patient outcomes. After patients receive angioplasty and a drug-eluting stent, their IMR is measured. Those with IMR above 32 are randomly assigned to receive either low-dose tenecteplase, a clot-dissolving drug, or a placebo of sterile water directly into the coronary artery. Patients with IMR 32 or below are monitored in a registry. The tenecteplase dose is one-third of the systemic weight-based dose, infused intracoronarily. Cardiac MRI scans are performed 3-7 days after the procedure and again at 6 months for randomized patients, with follow-up visits scheduled at 30 days, 6, 12, and 24 months. Throughout the study, participants undergo cardiac enzyme tests and clinical assessments. The primary outcomes measured include rates of cardiovascular death and rehospitalization for heart failure at 24 months, as well as the size of the heart attack and bleeding within the heart muscle at 6 months. The study carefully monitors safety and treatment effects through imaging and clinical follow-up to evaluate whether low-dose tenecteplase can improve long-term heart function after STEMI.

Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on clinical outcomes for patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. This study aims to determine whether the algorithm improves technical success immediately after the procedure and device success 30 days post-procedure. It is a multi-center, international, prospective cohort study enrolling about 290 patients eligible for TAVR or surgical aortic valve replacement (SAVR). The ABC Bicuspid Sizing Algorithm helps doctors assess CT scans to guide decisions on whether patients should receive TAVR or SAVR and to select the appropriate valve size for TAVR patients. In some cases, gated CT scans or artificial intelligence-based simulations are used for further evaluation. Physicians consider these findings along with other clinical factors to decide on the final treatment and valve deployment. About 230 patients are expected to undergo TAVR using the Sapien 3 valve. Participants will have data collected at several points: before the procedure, during the procedure, at hospital discharge, and at 30 days and one year after the procedure for TAVR patients. SAVR patients will have data collected only at baseline and during their procedure. The main outcome measured is the proportion of cases achieving technical success immediately after the procedure. The study includes sites across Canada, Latin America, the Middle East, and Asia Pacific regions.

Researchers are evaluating the effectiveness and safety of plixorafenib, an oral drug, in people aged 10 years and older who have various types of cancers with specific BRAF genetic changes. These include locally advanced or metastatic solid tumors, primary central nervous system (CNS) tumors with BRAF fusions, and rare BRAF V600-mutated tumors such as melanoma, thyroid cancer, and recurrent CNS tumors. The study is a Phase 2 Master Protocol designed to assess this targeted therapy in multiple subgroups based on tumor type and genetic profile. Participants receive plixorafenib oral tablets, and the study includes several subprotocols tailored to different tumor types and BRAF alterations. Subprotocols A, B, and C focus on tumors with BRAF fusions or rare BRAF mutations, while Subprotocol D enrolls adults aged 18 to 65 with solid tumors harboring BRAF V600E mutations not eligible for other subprotocols. Before starting treatment, participants provide tumor tissue or blood samples for genetic testing and scans to monitor tumor changes. Some subprotocols require stable or decreasing corticosteroid doses before treatment. Throughout the study, participants undergo regular evaluations including imaging scans, biopsies, and laboratory tests to assess tumor response and drug levels. The main outcomes measured are the objective response rate for most subprotocols and pharmacokinetics for Subprotocol D, with follow-up lasting up to approximately four years. Safety monitoring includes tracking adverse events and ensuring recovery from prior treatments, with additional assessments for heart function and infection status as needed.

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are studying the treatment LTP001 in two groups: healthy adults (Part A) and adults with pulmonary arterial hypertension (PAH) (Part B). The study aims to evaluate the safety, tolerability, and how the body processes LTP001 in healthy volunteers, and to assess the safety and effectiveness of LTP001 in participants with PAH. This trial includes a safety extension period for participants with PAH to monitor longer-term effects. In Part A, healthy adult participants will receive single and multiple ascending doses of LTP001 or placebo to assess safety and pharmacokinetics. Part B involves participants with confirmed PAH who will receive LTP001 or placebo alongside their standard PAH treatments. The study monitors participants from baseline through various treatment periods, including a treatment period of up to 106 weeks in Part B for long-term safety assessment. Participants will undergo evaluations including monitoring for adverse events and serious adverse events from baseline through Day 35 in Part A and through Week 106 in Part B. The study also measures changes in pulmonary vascular resistance (PVR) during Part B at Week 24. Assessments include physical exams, ECGs, and walking tests to evaluate heart and lung function. Researchers will track safety, efficacy, and tolerability throughout the study duration.