Teaneck

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating a new approach to prevent cardiovascular events in patients at increased risk due to age and conditions like type 2 diabetes, prediabetes, or metabolic syndrome but without known symptomatic cardiovascular disease. The study compares a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy with standard risk factor-based care to see if the former can better reduce cardiovascular events. The Cleerly system uses imaging to visualize and quantify coronary artery disease and guides personalized treatment and education based on this assessment. The trial uses the Cleerly CAD Staging System device, which employs a proprietary algorithm to detect and stage coronary artery disease and generate a risk score to guide treatment decisions. Participants receive either this stage-based care or the usual care based on traditional risk factors. The study is prospective, randomized, and pragmatic, designed to follow patients over an average of 3.5 years to compare cardiovascular event outcomes between these two care approaches. Participants will be monitored through cardiovascular event tracking throughout the study period. Data collected includes imaging results, risk scores, and treatment adherence to evaluate the impact of the care strategies. The primary outcome is the comparison of cardiovascular event risk between the Cleerly stage-based care and risk factor-based care groups. The study also includes ongoing safety monitoring and personalized management by a cardiologist-led team via digital communication devices.

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.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

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.

Researchers are studying the rate and severity of specific eye-related side effects caused by mirvetuximab soravtansine (MIRV) in women with recurrent ovarian cancer that has high folate receptor alpha (FRα) expression. This includes both platinum-sensitive and platinum-resistant ovarian cancer types. The study aims to assess different strategies to prevent these eye side effects through thorough eye exams conducted before and during treatment. This is a Phase 2 randomized trial. Participants will be randomly assigned to one of two groups to receive different eye drop treatments to reduce eye side effects: primary prophylactic steroid eye drops or primary prophylactic vasoconstricting eye drops. All participants receive mirvetuximab soravtansine, an antibody drug conjugate targeting FRα, with additional lubricating eye drops given at least 15 minutes after the steroid or vasoconstricting drops. The treatments are self-administered as prescribed by the study doctor. During the study, participants will undergo regular eye exams and monitoring to track any eye problems related to the treatment. Researchers will count how many participants develop moderate or worse eye side effects up to 18 weeks or until 30 days after treatment ends. Safety and eye health will be closely followed, including assessments of vision and any adverse events. The study focuses on women aged 18 and older with recurrent ovarian cancer who meet specific health and treatment history criteria.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes two parts: Phase 2 to find the best dose based on safety and response, and Phase 3 to compare R-DXd with the investigator's choice of chemotherapy. R-DXd is an antibody-drug conjugate that targets CDH6, a protein overexpressed in tumor cells. Participants will receive R-DXd through intravenous infusions. In Phase 2 (Part A), the dose will be optimized, and biopsies will be collected before and during treatment if possible. In Phase 3 (Part B), participants will be randomly assigned to receive either R-DXd or chemotherapy chosen by their doctor, which may include paclitaxel, topotecan, or PLD, all given by IV infusion. The study monitors treatment effects up to 18 months in Phase 2 and up to 26 months in Phase 3. During the study, participants will have regular scans and assessments to measure tumor response and progression-free survival. Researchers will monitor safety and organ function through lab tests and performance status evaluations. Participants must be willing to follow the study visits and procedures, which include biopsy samples in Phase 2 and imaging assessments to evaluate treatment response. The study aims to provide detailed information about how well R-DXd works and its safety in this patient group.

Researchers are evaluating the safety and effectiveness of neoadjuvant carboplatin combined with mirvetuximab soravtansine in adult women with folate receptor alpha (FRα)-expressing advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This is a single-arm Phase 2 study involving about 140 participants across approximately 80 sites in the United States. The study focuses on advanced disease stages III and IV, with FRα expression confirmed in tumor cells. Participants will receive intravenous infusions of mirvetuximab soravtansine together with carboplatin on day 1 of each 21-day cycle, continuing for up to 6 to 9 cycles. Bevacizumab may also be given as an intravenous infusion if the investigator decides it is appropriate. The total duration of the study is about 3 years, during which treatments and responses will be closely monitored. During the study, participants will attend regular visits at hospitals or clinics for medical evaluations including blood tests, scans, and safety assessments. Researchers will track tumor response using independent central review over the course of up to 3 years. The study involves frequent medical monitoring to assess treatment effects and participant safety.

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult participants with gynecologic cancers. IMGN151 is an investigational drug being developed for the treatment of gynecologic cancers. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 377 participants with gynecologic cancers will be enrolled in the study at approximately 50 sites worldwide. Participants will receive intravenous infusions of IMGN151 as monotherapy or in combination with anti-cancer therapies according to their assigned study arm. In Arm A, participants will receive IMGN151 in combination with carboplatin on Day 1 of each cycle. In Arm B, participants will receive IMGN151 in combination with olaparib, twice a day (BID) on Day 1 of each cycle. In Arm C, participants will receive IMGN151 in combination with bevacizumab on Day 1 of each cycle. In Arm D, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm E, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm F, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. The total study duration will be approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.