Sherman

Researchers are studying the safety and tolerability of budoprutug, a humanized monoclonal antibody that targets CD19 cells, in adults with primary membranous nephropathy (PMN). This Phase 2, open-label, multicenter trial focuses on patients who are anti-PLA2R antibody positive and continue to have proteinuria despite optimized RAAS inhibition. The study aims to evaluate three different intravenous dose regimens of budoprutug and their effects on this specific kidney condition. Participants will receive budoprutug through single intravenous doses on Day 1, Day 15, Day 169, and Day 183 within one of three sequential dose groups. Approximately 45 subjects will be enrolled, each receiving treatment according to their assigned dosing schedule. The study includes a follow-up period through Week 48, with additional monitoring for B-cell recovery as needed. During the study, participants will undergo safety assessments including monitoring for treatment-emergent adverse events up to 48 weeks. Researchers will also evaluate pharmacodynamics and preliminary efficacy through laboratory tests and clinical evaluations. Regular visits will include tests for kidney function, protein levels in urine, and blood cell counts, alongside other health assessments to ensure participant safety and gather data on how the drug affects the disease.

This research aims to evaluate the safety, tolerability, and impact on albuminuria of the drug MZE829 in adults who have proteinuric chronic kidney disease and carry the APOL1 high-risk genotype. This Phase 2 open-label study focuses on participants with specific genetic markers associated with kidney disease to better understand treatment effects. Participants will receive MZE829 in the form of oral capsules. The study involves monitoring the participants over a 12-week period to assess the drug's safety and how well patients tolerate it. Researchers will also measure changes in albuminuria, which reflects kidney function. During the study, participants will be closely monitored for any adverse events from the first day through week 12. Safety assessments and laboratory tests will be performed to track the drug’s effects. The main goal is to determine how safe and tolerable MZE829 is, along with its impact on kidney disease markers over the treatment duration.

Researchers are evaluating the safety and effectiveness of fixed dose combinations of ensifentrine with two different doses of glycopyrrolate compared to placebo and each drug alone in adults with chronic obstructive pulmonary disease (COPD). This phase IIb study focuses on measuring lung function improvements using bronchodilator effects in people with COPD. Participants have a history of smoking and meet specific lung function criteria to be included. Participants will be randomly assigned to one of six groups: two combination treatments of ensifentrine (3 mg) with glycopyrrolate at either 21.25 or 42.5 mcg, each drug alone as monotherapy, or placebo. All treatments are given twice daily for 28 days using a standard jet nebulizer. The study includes 1 to 2 weeks of screening, 4 weeks of treatment, followed by 1 week of follow-up. During the study, participants will undergo lung function testing at baseline and on days 1, 14, 28, and 29 to measure changes in forced expiratory volume in one second (FEV1). They will also have chest X-rays or CT scans reviewed, complete questionnaires on breathlessness, and have regular assessments to monitor safety and treatment effects. Participants must be able to use the nebulizer properly and attend all study visits over approximately 7 weeks.

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the efficacy and safety of orelabrutinib, a brain-penetrating BTK inhibitor, compared with placebo in adults with non-active Secondary Progressive Multiple Sclerosis (SPMS). This global phase 3 study involves about 990 participants randomized in a 2:1 ratio to receive orelabrutinib or placebo. The study focuses on patients with SPMS who have stable disease without clinical relapses for at least 24 months but with documented disability progression over the prior two years. Participants will undergo several study periods including up to 4 weeks of screening, followed by a treatment period lasting approximately 24 to 60 months depending on recruitment timing. During the double-blind treatment phase, participants receive either orelabrutinib or placebo once daily. Those experiencing confirmed disability progression after 24 weeks may enter a 2-year open-label orelabrutinib treatment. After treatment ends or if participants do not join the long-term safety study, a 4-week safety follow-up will occur. Throughout the study, participants will have regular assessments to monitor disability progression confirmed over at least 24 weeks, safety, and tolerability. Final study visits occur within 4 weeks of the study end. Those continuing on long-term treatment will not have a safety follow-up at study end. The main measure is the time to onset of confirmed disability progression events, assessed for up to about 120 weeks.

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 effects and safety of the study medicine PF-07275315 for treating moderate to severe chronic obstructive pulmonary disease (COPD), a condition that makes breathing difficult and lowers quality of life. This clinical trial includes adults aged 35 to 80 years who have had COPD for at least 12 months and a history of at least two moderate or severe COPD flare-ups in the past year. The study has two phases: Phase 2 and Phase 3, each designed to assess different outcomes related to lung function and lung flare-ups over time. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections (shots under the skin) at the clinic. The Phase 2 part lasts 24 weeks with 11 clinic visits and focuses on the change in lung function measured by forced expiratory volume in 1 second (FEV1). The Phase 3 part lasts 52 weeks with 18 clinic visits and evaluates the annual rate of moderate or severe COPD flare-ups. Both study phases compare the effects of PF-07275315 to the placebo to assess safety and effectiveness. During the study, participants will visit the clinic regularly for assessments including lung function tests and health evaluations. They will continue their usual COPD maintenance treatments throughout the trial. Researchers will monitor lung function changes and the frequency of COPD exacerbations as primary outcome measures. Participants remain in the study for about 40 weeks in Phase 2 or about 68 weeks in Phase 3, including follow-up visits to ensure safety and collect health information.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.