Greenfield

Researchers are monitoring the long-term safety of efgartigimod, a biological treatment, in patients with generalized myasthenia gravis (gMG). This study is a non-interventional, prospective, post-authorization safety study designed to observe patients who are either starting or already receiving efgartigimod, as well as those with gMG who have not been treated with it. The study aims to compare the occurrence of serious infections and other safety outcomes over a period of up to 10 years. Patients with gMG who are expected to begin efgartigimod treatment at enrollment or who are currently in their first treatment cycle will be included in the efgartigimod group. Those with gMG who are not starting efgartigimod and have never received it will be enrolled in a non-efgartigimod group. There are no assigned treatments or interventions from the researchers; the study simply observes patients as they receive routine care. Participants will be followed for up to 10 years to track safety outcomes, including serious infections. Data collection will involve routine clinical assessments and monitoring as per standard medical practice. The study observes the real-world use of efgartigimod and its safety profile in managing gMG, providing valuable long-term information without altering patients' treatment plans.

Researchers are evaluating the effects of iptacopan compared with a placebo in adults aged 18 to 85 years who have generalized Myasthenia Gravis positive for acetylcholine receptor antibodies (AChR+ gMG). This Phase III, randomized, double-blind, placebo-controlled, multicenter study aims to assess the efficacy, safety, and tolerability of iptacopan while participants continue their stable standard of care treatments. The study includes participants with moderate to severe gMG symptoms and positive diagnostic criteria. Participants will be randomly assigned in a 1:1 ratio to receive either iptacopan or a matching placebo in the form of hard gelatin capsules for six months (180 days). During this time, they will continue their stable standard of care treatments. After the double-blind treatment period, a maximum 60-month open-label extension phase is offered. Safety follow-up assessments will occur one week and one month after the last dose of study treatment. During the study, participants will be evaluated for changes in their Myasthenia Gravis Activity of Daily Living (MG-ADL) total score from baseline to month 6. Researchers will monitor safety and tolerability throughout the treatment and extension periods. Vaccination status, infection monitoring, and regular clinical assessments will be part of participant evaluations to ensure safety and track disease symptoms over time.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

This research aims to assess the effectiveness and safety of lebrikizumab in adults diagnosed with perennial allergic rhinitis, a condition characterized by year-round nasal allergy symptoms. The study is a Phase 3 trial involving adult participants who have confirmed allergic reactions to indoor allergens. Researchers are investigating how lebrikizumab compares with placebo, alongside standard intranasal corticosteroid therapy, to better understand treatment options for this condition. Participants will receive either the investigational drug lebrikizumab (LY3650150) administered by subcutaneous injection, a placebo injection, or standard intranasal corticosteroid spray. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment during the trial. Treatment and observation periods will span up to 29.5 months. During the study, participants will be monitored for changes in their nasal symptoms, specifically measuring the total nasal symptom score from the start of the study to week 16. Researchers will conduct various assessments including clinical evaluations and allergy testing to track symptom changes and treatment effects. Safety will be closely observed throughout the study duration, and participants may be followed for nearly two and a half years in total.

This research aims to evaluate the efficacy and safety of telitacicept in treating generalized myasthenia gravis (gMG), an autoimmune disease where autoantibodies disrupt nerve-to-muscle communication, causing muscle weakness that worsens with activity. The study addresses the challenge of limited effective therapies for this condition. Telitacicept is a fully human fusion protein designed to block specific immune system signals that promote B-cell growth and maturation, potentially reducing autoimmune symptoms in gMG. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension. Participants will receive subcutaneous injections of either telitacicept or placebo. The study includes a 4-week screening period, a 24-week double-blind treatment phase, a 48-week open-label extension, followed by a variable-duration extended open-label extension until telitacicept is approved or development ends, and an 8-week end-of-study follow-up. Participants will undergo assessments including the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score to measure changes in daily functioning by Week 24. The study also monitors safety and efficacy over the treatment and extension periods. Throughout the trial, various clinical evaluations will be conducted to track disease status and response to treatment, ensuring comprehensive monitoring of participant health and outcomes.

Researchers are evaluating the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA, both given as subcutaneous (SC) infusions, for maintenance treatment of adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). This Phase 3 trial includes participants who have previously received intravenous or subcutaneous immunoglobulin G treatments and aims to compare these two therapies' behavior in the body. Participants must have a confirmed diagnosis of CIDP and have responded to IgG treatment before, consistent with established diagnostic criteria. The study consists of multiple phases: screening, a ramp-up phase if needed, a HYQVIA treatment phase, a TAK-881 treatment phase, and finally, an extension phase. Participants who previously received conventional subcutaneous or intravenous immunoglobulin will start with a HYQVIA ramp-up phase 1 to 2 weeks after their last dose. Those already on HYQVIA proceed straight to treatment. Participants receive SC infusions of HYQVIA for 20 weeks, then switch to TAK-881 for 24 weeks. During the extension phase, home infusions are preferred, with clinic visits spaced between 12 and 24 weeks. Throughout the study, participants visit the clinic every 3 or 4 weeks during the initial phases. Researchers will monitor immunoglobulin G levels through blood tests at specified intervals to assess drug exposure. Safety and treatment adherence are tracked, and participants complete disability assessments. The total duration includes these treatment phases and the extension, with careful follow-up to evaluate the therapies' pharmacokinetic profiles and participant well-being.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This research aims to evaluate how well adults with new-onset generalized myasthenia gravis (gMG), who have had symptoms for less than one year, respond to treatment with efgartigimod PH20 SC. The study focuses on adults diagnosed with gMG who are seropositive for AChR antibodies and have moderate disease activity, as indicated by an MG-ADL score of 5 or higher. This phase 4, open-label study seeks to understand clinical outcomes in this specific patient group. Participants will receive subcutaneous injections of efgartigimod PH20 SC during a 51-week treatment period. The study involves a single group design without a comparator, where all enrolled subjects are treated with the study drug. The overall duration for each participant, including screening and follow-up, will be approximately 58 weeks. Throughout the study, researchers will monitor the proportion of participants achieving minimal symptom expression (MSE) of myasthenia gravis within the first 16 weeks of treatment. Participants will undergo assessments to evaluate their disease status and response to therapy over time. Safety and effectiveness will be closely observed during the treatment and follow-up periods to gather comprehensive data on participant outcomes.

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.