Mississauga

Researchers are evaluating the long-term safety and effectiveness of Afimkibart (also known as RO7790121) in adults with Atopic Dermatitis who previously participated in Afimkibart clinical trials. This Phase 2 extension study aims to further understand the effects of this treatment over an extended period. Participants will receive Afimkibart through subcutaneous injections following a schedule outlined in the study protocol. The study specifically includes those who showed improvement in their skin condition during the prior trial and continued evaluation at the Week 36 follow-up visit. During the study, participants will undergo various assessments including clinical evaluations of their skin condition and completion of questionnaires about their quality of life and symptom severity. Safety will be closely monitored by tracking any adverse events from the start of the study and continuing up to six years. Blood samples will also be collected to study the drug's behavior in the body.

Researchers are investigating the long-term safety and effectiveness of APG777, a treatment for moderate-to-severe atopic dermatitis (AD), in patients who have already completed an initial APG777 study. This phase 2, multicenter, double-blind study focuses on those who may benefit from extended treatment with APG777 to better understand its ongoing effects and safety over time. The study includes three main periods: a screening visit that occurs at the end of the previous study's maintenance period, an extended treatment period where participants receive APG777 subcutaneous injections every 12 or 24 weeks, and a post-treatment follow-up period. Participants will continue using their chosen non-medicated moisturizer from the previous study throughout this extension. During the study, participants' health and response to treatment will be closely monitored, including tracking any treatment-emergent adverse events for up to three years. Researchers will assess the long-term safety and efficacy of APG777 while ensuring participants remain compliant with study protocols. This ongoing observation aims to provide detailed information on how APG777 affects patients over extended use.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2b study to evaluate the safety and effectiveness of GIA632 in adults aged 18 years and older with non-segmental vitiligo (NSV). The study aims to find the best dose of GIA632 for further testing in a Phase 3 program. Participants must have a confirmed diagnosis of NSV with specific body surface area and Facial Vitiligo Area Scoring Index (F-VASI) scores. Participants will receive either GIA632 or a placebo during a 48-week core treatment period. This period is designed to establish the dose-response relationship and compare the effects of GIA632 with placebo. After this, there will be an extension phase to assess the longer-term safety and efficacy of the treatment. During the study, participants will be monitored for changes in their facial vitiligo through F-VASI scores from baseline to week 24. Researchers will also observe overall safety and treatment effects throughout the 48 weeks and the extension period. Participants will complete study-related questionnaires and follow study procedures to support the research assessments.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating different treatment strategies for patients hospitalized with Gram-negative bloodstream infections (GN BSIs) through the BALANCE+ trial. This adaptive platform trial uses an open-label, pragmatic design embedded in routine care to address important questions in managing GN BSIs, including antibiotic treatment duration, antibiotic de-escalation, oral antibiotic options, central line management, specific pathogen treatment, and follow-up blood cultures. The study builds on previous research and aims to improve patient outcomes and reduce antimicrobial resistance, a growing global health concern. The trial includes multiple treatment comparisons, such as de-escalation versus no de-escalation of antibiotics, oral beta-lactams versus non-beta-lactams, central vascular catheter retention versus replacement, cephalosporin versus carbapenem for low-risk AmpC organisms, and routine follow-up blood cultures versus no routine follow-up. Treatments are tailored based on blood culture results and clinical decisions, with specific protocols for antibiotic switching and catheter management. The trial uses Bayesian methods with interim analyses after every 1000 patients initially, then every 200 patients, and stops domains based on predefined criteria or sample sizes. Participants are patients admitted to hospitals with confirmed Gram-negative bacteremia who meet eligibility criteria for each domain. Assessments include monitoring for death, reinfection, readmission, and new antimicrobial resistance over 90 days, measured by the Desirability of Outcome Ranking (DOOR) scale. The trial incorporates detailed inclusion and exclusion criteria and collects data through routine clinical care, ensuring ongoing evaluation of treatment effectiveness and safety throughout the study period.

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 evaluating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. This phase 2 study compares different doses of CDR132L with a placebo, which is an inactive treatment. The study aims to understand the safety and effectiveness of CDR132L in reversing heart remodeling in this population. Participants will receive either CDR132L or placebo administered intravenously once every 4 weeks. The study treatment period lasts about 24 weeks, followed by additional assessments leading up to a total study duration of approximately 60 weeks. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the main phase. During the study, participants will undergo various evaluations including heart imaging via echocardiography to measure heart function and structure, laboratory tests including NT-proBNP levels, and monitoring of heart failure symptoms. The main outcome measured is the change in normalized microRNA-132-3p levels from baseline to week 24. Researchers will also monitor safety and treatment effects throughout the study, which includes regular visits and assessments over the full 60-week period.

Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that blocks multiple pro-inflammatory cytokines involved in atopic dermatitis. This phase 2, double-blind, placebo-controlled study focuses on adults with moderate to severe atopic dermatitis that has not responded adequately to topical treatments. Participants are observed over approximately 36 to 40 weeks to compare BFB759 with a placebo. Participants are randomly assigned to receive either BFB759 or a placebo, with dosing aimed at assessing different levels of the drug's effects. The study is designed as a parallel-arm trial, meaning groups receive different treatments simultaneously without crossover. The investigational drug targets key inflammatory pathways believed to drive symptoms in atopic dermatitis. During the study, participants attend regular visits for monitoring and assessments. Researchers evaluate the drug's efficacy at 16 and 32 weeks using specific outcome measures. Safety is closely monitored throughout the treatment period. Participants are also expected to follow study instructions, avoid certain medications, and complete all scheduled visits during the study duration.

Researchers are evaluating the safety and effectiveness of brenipatide compared to placebo for people with opioid use disorder. This study focuses on participants who are also using buprenorphine, with or without naloxone, as part of their treatment. The trial includes two parts, each with separate groups of participants, to better understand how brenipatide works alongside current therapies in early recovery from opioid use disorder. The study has two parts: Part A involves a double-blind treatment phase followed by an open-label extension, while Part B offers an open-label treatment only. Brenipatide and placebo are given as subcutaneous injections, and buprenorphine is administered either sublingually or buccally. Participants will be enrolled in only one part of the study, with treatment durations potentially lasting up to 144 weeks in Part A and 116 weeks in Part B, depending on enrollment timing and study progress. Participants will regularly attend study visits where they will be assessed through urine drug screens and self-reports to measure abstinence from opioid use. They will also maintain study diaries and complete questionnaires to track adherence and effects. The main outcomes measured include the percentage of weeks participants remain abstinent from opioids between weeks 13 and 24, verified by negative drug tests and no self-reported opioid use. Safety and long-term effectiveness will be monitored throughout the study duration.