Sherwood Park

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 safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the effects of three different dosing schedules of povorcitinib on lung function in adults with moderately to severely uncontrolled asthma. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess both the safety and efficacy of povorcitinib in improving respiratory outcomes for this patient group. Participants have a history of asthma treatment with medium- to high-dose ICS-LABA therapy and meet specific lung function criteria before enrollment. Participants will receive one of three povorcitinib dosing regimens or a placebo while continuing their background ICS-LABA therapy. The study includes multiple treatment arms to compare the effects of different doses. The intervention period lasts 24 weeks, during which pulmonary function and other health measures will be monitored. During the study, participants will undergo regular assessments, including lung function tests measuring pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) at baseline and week 24. Researchers will also monitor safety and collect data on asthma exacerbations and symptom control. The total participation time covers the treatment duration and follow-up evaluations to assess changes in pulmonary function and overall health status.

This research aims to evaluate the effects of povorcitinib on reducing itch and improving skin lesions in adults with prurigo nodularis, a chronic skin condition characterized by itchy nodules. The study is a Phase 3 trial designed to assess the safety and efficacy of this treatment compared to a placebo in participants aged 18 to 75 years with a confirmed diagnosis of prurigo nodularis lasting at least three months. Participants will receive either oral povorcitinib tablets or placebo tablets as part of the randomized, double-blind study. Key eligibility includes having significant itch severity and at least 20 pruriginous lesions on multiple body regions. The study monitors the treatment effects over 24 weeks, focusing on improvements in itch intensity and skin lesion severity. During the study, participants will be closely monitored for changes in their itch scores and skin condition. Researchers will assess the proportion of participants achieving specified improvements by Week 24. Safety and tolerability will also be evaluated throughout the trial. Participants will undergo regular assessments including clinical evaluations, laboratory tests, and adherence monitoring to track progress and any side effects over the course of the study.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the effect of a medicine called BI 765423 on lung function in adults aged 40 years and older who have idiopathic pulmonary fibrosis (IPF). Participants must have a forced vital capacity (FVC) of at least 45% of the predicted value and lung fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The study compares BI 765423 to a placebo to see if it can improve lung capacity after three months of treatment and also examines changes in lung health markers. Participants are randomly assigned to receive either BI 765423 or a placebo. The study drug is given as an intravenous infusion every four weeks. Participants may continue their standard IPF treatments during the study. The study lasts 8 to 10 months and includes several visits for screening, treatment, and follow-up. During the study, doctors regularly measure lung function by testing FVC and take blood samples to assess study outcomes. Researchers monitor participants' health and record any side effects. The main outcome measured is the absolute change in FVC from baseline after 12 weeks of treatment. Results from both groups will be compared to evaluate the treatment's effects.

Researchers are evaluating the safety and effectiveness of brivekimig in adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition. This Phase 2b, global, multi-center study is designed as a randomized, double-blind, placebo-controlled trial that tests different doses of brivekimig. The study aims to understand how well brivekimig works compared to a placebo in improving HS symptoms and to find the best dose. Participants will receive either brivekimig or a placebo as a subcutaneous injection. The study includes a dose-ranging phase followed by a maintenance period. The total duration of treatment in the randomized phase can last up to approximately 48 weeks. For those not entering the long-term extension, the study duration will be about 60 weeks, and for those transitioning to the long-term extension, it will be about 52 weeks. During the study, participants will be monitored regularly to assess their response to treatment, including the percentage achieving a clinical response called HiSCR75 by Week 16. Researchers will evaluate safety and efficacy through clinical assessments and follow participants throughout the study period. The total involvement per participant lasts up to around 60 weeks depending on extension study participation.

Researchers are evaluating the efficacy and safety of once-weekly injectable MET097 in adults who have obesity or are overweight with related weight complications, but who do not have type 2 diabetes. This phase 3, multi-center randomized controlled trial aims to understand how well MET097 works and how safe it is over a long period. The study will last 84 weeks, with the primary effectiveness measured after 64 weeks of treatment. Participants will receive either MET097 or a placebo, both given once a week by subcutaneous injection. The study compares these two groups to assess the impact of MET097 on weight and related health issues. The treatment period is followed by continued monitoring to evaluate longer-term effects up to 84 weeks. During the study, participants' body weight changes will be carefully tracked from the start through week 64, which is the main outcome measure. Additional health assessments will occur through the 84-week duration to monitor safety and overall responses. Participants will be supported and monitored regularly to assess the medication's impact and any side effects throughout the trial.

Osteoarthritis (OA) of the knee is a slowly progressing chronic condition mainly causing joint pain, especially in older adults. Early-stage OA is often unnoticed or untreated as patients usually do not seek medical care until symptoms worsen. Researchers are exploring how community pharmacists, who are easily accessible, can support patients with early knee OA by focusing on education, self-management, and exercise, since there are no disease-modifying treatments currently available. In this study, pharmacists will identify patients 50 years or older who have had knee pain, aching, or stiffness for at least one month. Eligible patients are randomly assigned to either usual care, which includes a brief pharmacist assessment and educational brochure, or an intervention involving a comprehensive pharmacist review with drug therapy recommendations and referral to physiotherapy. Physiotherapy will be offered as individual or group sessions at a private clinic. The pharmacist also communicates with the patient's family physician if applicable. Participants will complete baseline assessments including questionnaires about knee symptoms, medical history, lifestyle, and self-management skills either in the pharmacy or online. Researchers will monitor these outcomes at baseline and 3 and 6 months post-intervention using disease-specific self-report measures. The study evaluates how pharmacist and physiotherapist collaborative care influences patient outcomes and supports early management of knee OA.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.