Sherman

Researchers are evaluating the safety and tolerability of three different dose regimens of budoprutug in adults with primary membranous nephropathy PMN who test positive for anti-PLA2R antibodies and continue to have proteinuria despite optimized RAAS inhibition. This Phase 2, open-label, multicenter study aims to assess the safety, pharmacodynamics, and early effectiveness of budoprutug, a humanized monoclonal antibody that targets CD19 to deplete specific cells through antibody-dependent cellular cytotoxicity. Participants will receive a single intravenous dose of budoprutug on Days 1, 15, 169, and 183 across three sequential dose groups. Approximately 45 subjects will be enrolled and treated with one of the three dose levels. The study includes an initial dosing period followed by extended follow-up to monitor B-cell recovery and other effects up to Week 48. During the study, participants will be closely monitored for adverse events and changes in various laboratory measures, including B cell counts, anti-PLA2R antibody levels, proteinuria, and kidney function. Researchers will evaluate safety outcomes up to Week 48 and assess pharmacokinetics such as plasma concentration and clearance. Follow-up visits will track participant health, treatment effects, and recovery over the course of the study.

This trial investigates MZE829 capsules in adults with proteinuric chronic kidney disease who also carry the APOL1 high risk genotype, specifically G1G1, G2G2, or G1G2 variants. The study aims to evaluate the safety, tolerability, and impact on albuminuria, a marker of kidney damage, in this population. It is an open-label Phase 2 trial, meaning all participants receive the study drug and results will help determine its effects and safety profile. Participants receive MZE829 capsules orally in a single-group design. The study includes two cohorts one with chronic kidney disease alongside diabetes, and another with chronic kidney disease without diabetes. The treatment and monitoring occur over a 12-week period, during which the study team assesses drug safety and effects on albuminuria levels. During the trial, participants will be monitored for adverse events and tolerability from baseline through week 12. Researchers will also measure changes in urine albumin-to-creatinine ratio UACR to evaluate kidney function. Blood samples will be taken to assess plasma drug concentrations. The total participation time is approximately 12 weeks, focusing on safety and biological effects of MZE829.

Researchers are evaluating the pharmacodynamic effect, safety, and tolerability of Povetacicept in adults with generalized myasthenia gravis gMG. This phase 2 study focuses on participants aged 18 to 80 years who have generalized muscle weakness and fall within the MGFA clinical classification II-IV. The study aims to better understand how Povetacicept affects immunoglobulin levels and the safety profile in this population. Participants will be randomly assigned to receive one of two doses of Povetacicept or a placebo via subcutaneous injection for the initial 12 weeks. Those who are eligible may continue treatment with Povetacicept for an additional 96 weeks in a long-term extension phase. This study uses a double-blind, placebo-controlled design to evaluate the treatment over a total period of up to 108 weeks. During the study, participants will undergo evaluations of immunoglobulin G levels at baseline and week 12. Safety and tolerability will be monitored throughout the entire treatment period by tracking adverse and serious adverse events. The study includes regular assessments to measure outcomes and monitor participant health, with the goal of completing by March 2029.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating orelabrutinib, a brain-penetrating BTK inhibitor, in adults with Primary Progressive Multiple Sclerosis PPMS. This phase 3, randomized, double-blind, parallel-group, multicenter study compares orelabrutinib to placebo to assess its efficacy and safety in treating PPMS. About 705 participants aged 18 to 60 years will be enrolled globally with a 21 randomization favoring orelabrutinib. Participants will receive either oral orelabrutinib or a matching placebo. Treatment will last approximately 30 to 60 months, with a minimum of 12 months on study drug. The study includes two groups one receiving orelabrutinib and the other receiving placebo, both administered orally. The trial design is intended to monitor long-term effects and progression. During the study, participants will undergo regular assessments including disability progression measured over 12 weeks and up to approximately 120 weeks. Evaluations include MRI scans to monitor lesions, timed walking and hand function tests, cognitive testing, and safety assessments such as monitoring adverse events. The study will closely follow participants for up to 5 years to understand the impact of the treatment on disease progression and safety.

This trial investigates orelabrutinib, a brain-penetrating BTK inhibitor, in patients with non-active Secondary Progressive Multiple Sclerosis SPMS. It is a phase 3, randomized, double-blind, multicenter study comparing the effects and safety of orelabrutinib against a placebo. The study will enroll about 990 participants worldwide, focusing on those with SPMS who have not had recent relapses. Participants will be randomly assigned in a 21 ratio to receive either oral orelabrutinib daily or a placebo. After a screening period of up to 4 weeks, the treatment period will last from approximately 24 to 60 months, with a minimum of 12 months treatment. Those who experience confirmed disability progression may enter a 2-year open-label phase receiving orelabrutinib. A 4-week safety follow-up will occur for those who discontinue treatment before study end or do not enter long-term safety monitoring. During the study, participants will have assessments including disability progression measured over 24 weeks, MRI scans, and various functional tests up to about 120 weeks. Researchers will monitor safety and tolerability throughout. Participants will have a final end-of-study visit within 4 weeks after study completion, with ongoing treatment or follow-up depending on eligibility for long-term safety studies.

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.

Researchers are evaluating whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G IgG in the blood over time as Gamunex-C, administered into a vein once every three weeks, in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP. This Phase 3 study aims to assess the pharmacokinetics and safety of these two treatments in participants diagnosed according to established criteria. Participants will first undergo up to 28 days of screening to confirm eligibility. Those who qualify will enter a 19-week intravenous IV treatment phase receiving Gamunex-C every three weeks, totaling seven doses. Following this, approximately one week after the last IV dose, participants will begin a 16-week subcutaneous SC treatment phase with XEMBIFY once weekly, for a total of 16 doses. Blood samples will be collected during both treatment phases to measure IgG levels. Throughout the study, participants will have regular assessments including blood draws to monitor IgG concentration and safety. The primary outcome measures focus on the steady-state area under the concentration-time curve AUC of total IgG during both the IV and SC treatment phases. Secondary outcomes include the mean trough concentration of IgG. The total study duration includes screening, two sequential treatment periods, and follow-up assessments, with the study completion expected by the end of 2027.

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 evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.