Greenfield

This research aims to observe the long-term safety of efgartigimod treatment in adults with generalized myasthenia gravis gMG. It compares patients who are starting or have recently started efgartigimod treatment with those who have not been exposed to efgartigimod and are receiving other standard treatments. The study is non-interventional and prospective, focusing on real-world safety outcomes over an extended period. Participants are divided into two groups one receiving efgartigimod and another receiving other medications for myasthenia gravis. This study does not involve any new treatments being administered as part of the trial but monitors patients during their routine care. The study will continue for up to 10 years to gather long-term safety data. During the study, researchers will track the occurrence of serious infections and other safety concerns in both groups. Patients will be monitored through their regular clinical visits without additional interventions from the study. Participants may be followed for up to 10 years to assess safety outcomes associated with their treatments in everyday medical practice.

Researchers are evaluating the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate, delivered via a multidose dry powder inhaler with an electronic module, in participants aged 12 years and older with asthma. This Phase 3 trial aims to compare this combination treatment to fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. The study also assesses different dosing schedules, safety, tolerability, and pharmacokinetics of these inhalers. Participants will be randomly assigned to one of four groups receiving either the combination inhaler, fluticasone propionate inhaler, albuterol sulfate inhaler, or placebo, all with integrated electronic modules. Treatments are administered over a 4-week period with dosing four times daily. Pharmacokinetic assessments will be conducted after a single dose administration. The study is double-blind and placebo-controlled, with a parallel group design. Throughout the approximately 10-week study period, including screening and treatment, participants will undergo evaluations including lung function tests measuring forced expiratory volume in one second FEV1, asthma control questionnaires, and safety assessments. Researchers will monitor treatment-emergent adverse events and measure blood concentrations of the inhaled drugs. The study includes electronic monitoring of inhaler use and collects data at baseline, during treatment, and at week 4, with follow-up to assess efficacy and safety.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

Generalized myasthenia gravis gMG is an autoimmune disorder that causes muscle weakness due to autoantibodies affecting nerve-to-muscle communication. This research evaluates the safety and effectiveness of telitacicept, a drug designed to target immune system proteins involved in the disease. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension to further assess telitacicepts impact on gMG symptoms. Participants receive either telitacicept or a placebo through subcutaneous injections during the 24-week double-blind treatment period. Afterward, eligible participants may continue in a 48-week open-label extension where all receive telitacicept, followed by a variable extended open-label period until telitacicept is approved or further development ends. The study includes a 4-week screening phase before treatment and an 8-week follow-up after treatment completion. Throughout the trial, participants undergo assessments including muscle strength and daily living activity scores to measure treatment effects. Researchers monitor safety, quality of life, and muscle function using tools like the Myasthenia Gravis-Activities of Daily Living MG-ADL and Quantitative Myasthenia Gravis QMG scores. Study visits and evaluations track progress over the treatment and extension phases, with a total study duration depending on the participants time in the extended open-label period.

Researchers are evaluating the pharmacokinetic comparability between TAK-881 and HYQVIA when given as subcutaneous injections for maintenance therapy in adults with chronic inflammatory demyelinating polyradiculoneuropathy CIDP. This phase 3 trial focuses on participants who have been receiving intravenous or subcutaneous immunoglobulin treatments and aims to compare these two treatments in terms of how the body absorbs and processes them. The study includes several phases starting with screening and possibly a ramp-up phase for those switching treatments. Participants already on HYQVIA go directly to that treatment phase, which lasts 18 to 20 weeks depending on dosing intervals. Then all participants switch to TAK-881 for 24 weeks. After this, an extension phase allows continued treatment for up to 3 years, with home infusions permitted and clinic visits spaced between 12 and 24 weeks. Treatments are given by subcutaneous infusion using specialized needle sets. Participants will visit the clinic every 3 or 4 weeks during the initial phases to undergo assessments including blood sampling to measure immunoglobulin G levels at various time points. The study also tracks clinical disability scores, hand grip strength, muscle strength, and adverse events over time. Safety and treatment tolerability are closely monitored throughout the trial. Total participation may last several years including the extension phase.

Researchers are evaluating how well adults with new-onset generalized myasthenia gravis gMG respond to treatment with efgartigimod PH20 SC. This study focuses on adults who have had generalized disease signs or symptoms for less than one year and aims to assess clinical outcomes during a phase 4, open-label, single-group trial. Participants will receive subcutaneous injections of efgartigimod PH20 SC during a treatment period lasting 51 weeks. The study follows each participant for approximately 58 weeks to monitor their response to the treatment and any changes in their condition over time. During the study, participants will be regularly evaluated using measures like the proportion who achieve minimal symptom expression MSE within the first 16 weeks, changes in MG-ADL and MG-QOL-15r scores over time, and use of systemic corticosteroids as add-on therapy. Researchers will also monitor the incidence of adverse events throughout the study period to assess safety and tolerability.

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 the efficacy, safety, and tolerability of remibrutinib compared to a placebo in adult patients with Generalized Myasthenia Gravis gMG who are already on stable standard-of-care treatments. This multicenter Phase III study is randomized, double-blind, and placebo-controlled, aiming to provide important information about remibrutinibs impact on gMG symptoms. Participants will be randomly assigned to one of two groups one receiving remibrutinib tablets orally, and the other receiving matching placebo tablets, both during a 6-month core treatment period. Following this, participants can join an extension phase lasting up to 60 months, where all will receive open-label remibrutinib tablets orally. During the study, participants will undergo various assessments to monitor their symptoms and quality of life, including the Myasthenia Gravis Activity of Daily Living MG-ADL score and other clinical scales. Safety and tolerability will also be closely observed throughout the core and extension periods. The total duration of participation may extend up to nearly six years, including both study phases.

Researchers are evaluating the effects of remibrutinib compared to continuous ocrelizumab treatment in people living with relapsing multiple sclerosis RMS. This Phase 3b study aims to provide data on the efficacy, safety, and tolerability of remibrutinib when patients switch from ocrelizumab. The trial is randomized, open-label, and conducted across multiple centers globally, including the USA. Participants in the study are assigned to either switch to remibrutinib tablets taken orally or continue with ocrelizumab administered via infusion or injection at standard doses. The study includes a Core Part lasting up to 24 months, during which these treatments are compared. Those completing the Core Part may enter an Extension Part lasting up to 24 months, where all participants receive remibrutinib in an open-label format. Throughout the study, participants will undergo regular monitoring including MRI scans to measure new or enlarging T2 lesions and assessments for disease activity and adverse events. The main outcome is the annualized rate of new or enlarging T2 lesions during the Core Part, with continued evaluations during the Extension Part. Safety and tolerability are closely monitored, and total participation can last up to 48 months.

This research aims to better understand cancer cachexia CC, a condition involving weight, muscle, and fat loss that affects patients with advanced colorectal, lung, or pancreatic cancer that cannot be removed by surgery or is at stage IV. CC is linked to reduced physical function, lower quality of life, and poorer survival. The study seeks to identify different subtypes of CC based on patient characteristics to improve diagnosis and tailor treatments more effectively than a one-size-fits-all approach. It also aims to validate these subtypes and explore tumor factors that may contribute to CC. Participants will complete surveys and physical function tests lasting about 30 minutes each, provide blood samples and archived tumor tissue, and wear an actigraph device for 7 days to monitor sleep and activity. These assessments occur at the start of the study and again after three months. Standard imaging scans such as CT or PETCT are performed as part of usual care throughout the study. Medical records are reviewed at baseline, 3 months, and 1 year to collect comprehensive clinical data. During the study, researchers will evaluate physical function, symptoms, body composition, blood biomarkers, and activity levels to identify distinct CC diagnostic subtypes and their association with survival. Surveys and functional tests help measure symptoms and physical ability. The actigraph tracks daily activity and sleep patterns. The study follows participants for up to one year to monitor changes and outcomes, aiming to build a detailed database to support future research and clinical trials for cancer-related weight and muscle loss.