North Bay

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderate to severe Crohn's disease who have experienced inadequate response, loss of response or intolerance to either one prior interleukin \[IL\] antagonist, and no other biologic/small molecule (Group A); one IL antagonist and either one Janus kinase inhibitor (JAKi) or one TNFi (other than adalimumab) \[Group B\] (Cohort 1) or one prior tumor necrosis factor inhibitor \[TNFi\] and no other biologic/small molecule (Group C); one TNFi and either 1 JAKi or one IL antagonist (other than UST) (Group D) (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy. The study will enroll approximately 100 participants. Participants will be assigned to one of the two treatment groups in Part A: * Part A, Cohort 1: Vedolizumab + Adalimumab * Part A, Cohort 2: Vedolizumab + Ustekinumab All participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug). This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.

Researchers are evaluating the effects of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults who have moderate to severe ulcerative colitis (UC) and have not responded well to or tolerated up to two previous tumor necrosis factor (TNF) antagonist treatments. This Phase 4, open-label study focuses on the clinical remission achieved with this dual targeted therapy. The study includes about 65 participants and is being conducted at multiple centers in the United States and Canada. All participants will receive vedolizumab 300 mg intravenously together with tofacitinib 10 mg orally for the first 8 weeks. Those who respond to this combined treatment at Week 8 will then continue with vedolizumab alone for an additional 44 weeks. The total study duration for each participant can be up to 76 weeks, including a follow-up period of 26 weeks after the last dose of vedolizumab to monitor safety. During the study, participants will be regularly assessed for clinical response using the complete Mayo score at Week 8. The researchers will also monitor safety and remission status throughout the treatment and follow-up periods. Participants will undergo endoscopic evaluations, clinical exams, and laboratory tests to track their ulcerative colitis activity and response to the therapies.

Researchers are evaluating the efficacy and safety of different dose regimens of IMG-007 compared to placebo in adult participants with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will last up to 52 weeks and aims to find the best dosing strategy for this condition. Participants will receive either IMG-007 or a placebo by subcutaneous injection. The study involves multiple dose regimens to assess how well IMG-007 works and how safe it is. Participants will be randomly assigned to one of the treatment groups, and both participants and researchers will be unaware of the treatment assignment to ensure unbiased results. During the study, participants will be monitored regularly with assessments including the Eczema Area and Severity Index (EASI) to measure skin condition changes, focusing on the mean percent change from baseline at Week 20. Safety will also be closely tracked throughout the study. The total participation period may extend up to 52 weeks, allowing for thorough evaluation of treatment effects and safety over time.

Researchers are conducting a multicenter, randomized, double-blinded, placebo-controlled study to find the best dose of ORKA-002 for adults with moderate-to-severe plaque psoriasis. The study aims to evaluate the effectiveness and safety of ORKA-002 compared to a placebo. Approximately 160 adult participants diagnosed with plaque psoriasis for more than 6 months, who are candidates for systemic therapy or phototherapy, will take part in this Phase 2 trial. Participants will receive one of three induction dosing regimens of ORKA-002 or a placebo, both administered by subcutaneous injection. The study consists of three periods: a screening period, an induction period where treatment is given, and a post-treatment follow-up period to monitor outcomes and safety. The goal is to identify the optimal dosing regimen that provides the best balance of efficacy and safety. During the study, participants will be assessed for the proportion achieving complete clearance of psoriasis skin symptoms (100% reduction in PASI score) by week 16. Researchers will also monitor for any treatment-emergent adverse events or serious side effects through week 48. Participants will undergo various evaluations including clinical assessments and safety monitoring throughout the study duration.

Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

Syncope, a sudden temporary loss of consciousness, often leads patients to visit emergency departments (EDs). While many cases are harmless, some have serious heart-related or other causes that may not be obvious during initial ED assessment. Researchers have developed the Canadian Syncope Risk Score (CSRS) to help identify which patients need further tests, monitoring, or hospital admission. This study evaluates how well implementing CSRS-based recommendations in Canadian EDs improves patient safety and reduces unnecessary hospitalizations and ED stay times through a large, multi-center stepped wedge cluster randomized trial. The study involves 16 ED clusters across Canada split into two groups, each participating over 16 months. All sites start with usual care for three months, then gradually adopt the CSRS intervention in random order every three months until all have implemented it. The CSRS-based practice recommendations include thorough clinical evaluation, testing like troponin or CT scans as needed, using the CSRS to assess risk at the end of the ED visit, providing patient information materials, and providing 15-day outpatient heart monitoring for medium and high-risk patients. Emergency physicians will apply all these components during patient care. Participants are adults over 18 who arrive at the ED within 24 hours of a syncope episode. Researchers will measure hospital admission rates around the time of ED disposition, ED length of stay, and use of investigations. They will also assess physician adoption of the CSRS, patient safety outcomes over 30 days and one year including serious events, repeat ED visits, hospitalizations, and mortality. The study includes a transition period for implementation and ongoing monitoring of how well the CSRS recommendations are maintained after adoption.