Sherwood Park

Researchers are evaluating AZD8965 in a Phase IIb trial to study its safety, tolerability, and effectiveness in treating Idiopathic Pulmonary Fibrosis IPF. The study compares three doses of AZD8965 to a placebo in participants with IPF, including those who are on stable doses of approved antifibrotic therapies such as nintedanib, pirfenidone, or nerandomilast, as well as those not taking antifibrotic treatment. The trial is randomized, placebo-controlled, double-blind, and parallel-group in design. Participants are assigned to one of four groups placebo, low dose AZD8965, medium dose AZD8965, or high dose AZD8965. The treatment lasts for 24 weeks, during which participants receive their assigned medication. The study includes approximately 360 participants across around 200 sites worldwide. Researchers aim to assess the clinical efficacy of AZD8965 by measuring changes in lung function and study the relationship between dose and outcomes. During the study, participants will undergo various assessments including lung function tests such as forced vital capacity FVC, monitoring for adverse events, and pharmacokinetic analyses of AZD8965. Safety and tolerability are monitored up to 25 weeks. Researchers will also track any serious adverse events and treatment discontinuations. The total participation time covers the 24-week treatment period with scheduled visits to assess the study outcomes and participant health.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

This research is focused on adults aged 40 and older who have idiopathic pulmonary fibrosis IPF, a lung condition characterized by scarring and reduced lung function. The study aims to evaluate whether the medicine BI 765423 can improve lung capacity compared to a placebo. Participants must have certain lung function levels and evidence of lung fibrosis confirmed by imaging to join the study. Participants are randomly assigned to one of two groups one receives BI 765423 through an intravenous infusion every four weeks, and the other receives a placebo that looks the same but contains no active medicine. The study lasts up to 11 months, during which participants may continue their standard IPF treatments. The main treatment period focuses on observing changes in lung function over 3 to 6 months. During the trial, participants visit the study site several times for screening, treatment, and follow-up assessments. Doctors measure lung function with tests like forced vital capacity FVC and collect blood samples to monitor markers of lung health. The study compares results between the groups to assess the effects of BI 765423, while also monitoring participants overall health and any side effects.

Researchers are studying the effects and safety of the medicine PF-07275315 for adults aged 35 to 80 with moderate to severe chronic obstructive pulmonary disease COPD. COPD makes breathing difficult and reduces quality of life. This clinical trial aims to evaluate PF-07275315 compared to placebo to assess its potential as a treatment for COPD. Participants will receive either multiple injections of PF-07275315 or placebo shots in a clinic over 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. The study uses a randomized and parallel design to compare outcomes between the groups. Phase 2 participants will have 11 clinic visits over about 40 weeks, while Phase 3 participants will have 18 visits over about 68 weeks. During the trial, participants will undergo lung function tests including forced expiratory volume FEV1 measurements, and assessments of COPD exacerbations. Researchers will monitor safety, adverse events, and changes in respiratory symptoms and quality of life. The study includes regular clinic visits for treatment and evaluations, with the total duration depending on the phase of participation.

Researchers are studying Brivekimig, a medication given as a subcutaneous injection, in people with moderate to severe hidradenitis suppurativa HS. This Phase 2b, global, randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of different doses of Brivekimig for treating HS. Participants have had HS for at least six months and have moderate to severe symptoms affecting multiple areas of the body. Participants will be randomly assigned to receive one of three dosing regimens of Brivekimig or a matching placebo. The study drug is given through injections and the treatment period lasts up to approximately 48 weeks. Some participants may continue into a longer-term extension study, making total participation last up to about 52 to 60 weeks. The trial includes a maintenance period following the initial treatment. During the study, participants will have regular visits to assess their skin condition, pain levels, quality of life, and any side effects. Researchers will measure improvements using tools like the Hidradenitis Suppurativa Clinical Response HiSCR at various points up to Week 16. Safety will be monitored throughout the study, including tracking adverse events and laboratory tests. Participants drug levels and immune responses will also be checked. Overall, the trial will last up to about 60 weeks depending on extension participation.

Osteoarthritis OA of the knee is a slowly progressing chronic condition linked to aging, causing joint pain. Early-stage OA often goes unreported to doctors, with patients frequently seeking over-the-counter remedies from pharmacies. This study aims to use community pharmacists accessibility to support patients with early knee OA through education, self-management, and exercise, as there are currently no treatments that modify the disease itself. The study compares usual care to a pharmacist-physiotherapist collaborative intervention. Pharmacists will identify patients with knee pain and enroll those aged 50 or older experiencing knee pain or stiffness for at least one month. Participants are randomized to either receive usual care, which includes basic pharmacist advice and education, or an intervention involving a comprehensive pharmacist assessment, medication review, shared decision-making on drug therapy, and referral to physiotherapy. Physiotherapy includes a 6-week neuromuscular exercise program and group education sessions. Participants will complete baseline assessments covering symptoms, medical history, lifestyle, and self-management abilities. Follow-up evaluations occur at 3 and 6 months to measure disease-specific outcomes and patient activation. Pharmacists and physiotherapists will monitor progress and provide education. The study tracks effectiveness of the collaborative approach in managing early knee OA over the study period ending in 2027, with participant involvement including questionnaires, medication reviews, and physiotherapy sessions as applicable.

This research aims to evaluate the effects of combining baxdrostat 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 a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

This trial is a rollover study for adults who previously participated in specific Incyte-sponsored clinical trials involving the drug povorcitinib. It focuses on people with Hidradenitis Suppurativa HS, a condition being studied to better understand the long-term safety and effects of continuing povorcitinib treatment. The purpose is to monitor participants who have already benefited from povorcitinib in earlier studies, now entering an extended phase to further evaluate safety and treatment outcomes. Participants will continue taking povorcitinib orally, following the same dose and schedule they had in their original parent study. This study does not test new doses or compare treatments but observes continued use of the drug under the established regimen. The study may last for up to approximately three years, reflecting extended monitoring rather than initial treatment phases. During the study, participants will attend scheduled visits for assessments, including tracking any treatment-emergent adverse events and measuring symptom counts related to HS. Researchers will collect safety data over the long term and observe clinical responses. Participants must adhere to study procedures and avoid pregnancy or fathering children as required. The study aims to provide detailed safety information over an extended period while participants remain on the drug regimen from their original trial.