Beckley

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjögren's Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are evaluating the long-term safety of avacopan in people with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a condition involving inflammation of blood vessels. This phase 4 clinical trial focuses on assessing the safety and efficacy of avacopan over an extended period to understand its impact when combined with standard immunosuppressive treatments. Participants are randomly assigned to one of three groups: one group receives 30 mg of avacopan twice daily for 5 years along with standard care; another group takes avacopan for 1 year followed by placebo for 4 years, plus standard care; the third group receives placebo twice daily for 5 years combined with standard care. Standard care includes background immunosuppressive therapy tailored by the investigator according to guidelines and individual patient needs. Throughout the study, participants undergo regular monitoring for treatment-emergent adverse events, serious adverse events, and changes in vital signs, blood, urine, and serum chemistry over 60 months. Researchers also measure remission rates, relapse times, kidney function, quality of life, and glucocorticoid or immunosuppressant use. The study spans up to 5 years, with ongoing assessments to evaluate long-term safety and health outcomes.

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), including polymyositis (PM) and dermatomyositis (DM). This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

This trial investigates adults with active psoriatic arthritis or active axial spondyloarthritis to compare two ways of giving the drug bimekizumab: intravenously (IV) or by subcutaneous (under the skin) injection. The study aims to show that intravenous administration is not less effective than subcutaneous administration in how the drug moves through the body. It is an open-label, randomized, Phase 1 study sponsored by UCB Biopharma SRL focused on pharmacokinetics and safety.

This trial studies adults 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases (SARD-ILD). It focuses on people whose lung function has not improved after standard immunosuppressant treatment. The study aims to learn how the medicine nerandomilast affects lung health in these patients by comparing it to a placebo, with the trial sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of two groups: one takes nerandomilast tablets and the other takes placebo tablets that look identical but contain no medicine. They take the tablets twice daily for at least 26 weeks and up to one year while continuing their usual immunosuppressive therapy. The trial is double-blind and placebo-controlled to fairly evaluate the effects of nerandomilast. Each participant stays in the study for about 7.5 to 13 months, depending on when they start. During this time, they visit the study site 9 to 10 times for lung function tests and chest imaging at select visits. They also complete questionnaires about symptoms and quality of life. The researchers monitor health regularly and record any side effects. The main outcome is the change in lung disease extent measured by CT scans after 26 weeks.

Researchers are evaluating how the study medicine PF-06823859 (dazukibart) works in adults with idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM). These conditions cause muscle inflammation leading to weakness and may include a skin rash in DM. The study aims to assess the safety and effects of dazukibart compared to a placebo in people receiving stable doses of corticosteroids or immunosuppressants. Participants will receive either the study medicine or a placebo through an intravenous infusion lasting about one hour. These infusions occur every four weeks from Day 1 through Week 48 at the study site. The study is randomized and double-blind, meaning neither participants nor researchers know who gets the medicine or placebo during the trial. Participants will be involved for about 13 months, attending 15 visits at the study site. During these visits, muscle strength, skin condition, physical function, fatigue, itch, and corticosteroid use are assessed. The main measurement is the Total Improvement Score at 24 or 52 weeks depending on location. Safety and other symptom measures will be monitored throughout the study period.

Researchers are studying how the medicine dazukibart works in people with active idiopathic inflammatory myopathies, specifically dermatomyositis (DM) or polymyositis (PM). These conditions cause inflammation and weakness in muscles near the body’s center, affecting activities like climbing stairs or lifting objects. DM also involves a skin rash, and these disorders can impact lung and heart function, reducing quality of life. This trial is designed as a Phase 3, multi-center, open-label extension to assess long-term safety, tolerability, and effects of dazukibart. Participants who took part in a prior dazukibart study and completed up to Week 52 may join this extension. Those receiving dazukibart will get an intravenous (IV) infusion lasting about one hour every 4 weeks for up to 48 weeks (about 12 months). After the treatment period, there is a safety follow-up lasting about 4 months. Participants who choose not to receive the study medicine or are ineligible will only participate in safety follow-up visits, which happen every 4 weeks for up to 4 visits. During the study, participants receiving dazukibart will attend about 18 visits over roughly 16 months, while those on safety follow-up alone will have up to 4 visits. The trial monitors treatment-emergent side effects, lab and vital sign changes, lung function (Forced Vital Capacity and lung gas exchange), and mental health using the Columbia-Suicide Severity Rating Scale. Secondary measures include muscle strength, disease activity assessments, patient-reported physical function, fatigue, quality of life, and medication use. This comprehensive monitoring helps evaluate the long-term impact of dazukibart in managing idiopathic inflammatory myopathies.

Researchers are evaluating the efficacy, safety, and tolerability of the drug lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 randomized, double-blind, placebo-controlled study aims to better understand how lunsekimig works in this specific COPD population. Participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a 48-week treatment period. There are three study groups: lunsekimig dose regimen A, lunsekimig dose regimen B, and placebo. The study includes a screening period of up to 4 weeks, followed by the randomized intervention period, and then an 8-week follow-up period, totaling approximately 60 weeks of participation. Throughout the study, participants will undergo various assessments such as lung function tests measuring forced expiratory volume (FEV1), symptom and quality-of-life questionnaires including the Chronic Airways Assessment Test (CAAT) and the St. George's Respiratory Questionnaire (SGRQ-C). Researchers will monitor the rate and severity of COPD exacerbations, record any adverse events, and measure blood levels of lunsekimig and related antibodies. Safety and tolerability will be observed until 56 weeks from baseline.

Researchers are evaluating the clinical efficacy and safety of sonelokimab compared with placebo in adults with active psoriatic arthritis who have previously shown inadequate response or intolerance to anti-tumor necrosis factor (TNF) alpha therapy. This Phase 3, randomized, double-blind, placebo-controlled study also includes risankizumab as an active reference to further assess treatment options for this condition. Participants are assigned to one of four groups: two different doses of sonelokimab given by subcutaneous injection as an induction regimen of four doses followed by maintenance dosing every four weeks starting at Week 8, a placebo group receiving subcutaneous injections, or a group receiving risankizumab by subcutaneous injection. The study compares the effects of these treatments over time. Throughout the study, participants will undergo regular assessments for improvement in psoriatic arthritis symptoms using the American College of Rheumatology criteria (ACR50 and ACR20) and other measures like Minimal Disease Activity, the Health Assessment Questionnaire Disability Index, Psoriasis Area and Severity Index, and quality of life surveys. Safety and response rates will be closely monitored, with primary outcome measurement at Week 16. The study is expected to continue until January 2027.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.