Cape Coral

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants with non-alcoholic fatty liver disease and metabolic syndrome components, aiming to better understand treatment effects in this population. Participants will receive either Efimosfermin Alfa injection or a placebo, with the study designed as a three-arm trial. The treatment will be administered according to the study protocol, though specific dosing details are not provided. The study will monitor participants over a period extending to at least 52 weeks, comparing the safety and tolerability of Efimosfermin Alfa against placebo. During the study, participants will be closely observed through clinical assessments including monitoring for treatment-emergent adverse events (TEAEs), laboratory tests to detect Grade 3 and Grade 4 abnormalities, and evaluation of any adverse events leading to discontinuation of treatment. These safety and tolerability measures will be recorded at Week 52, helping researchers assess the impact of Efimosfermin Alfa over time.

This research aims to evaluate the safety and effectiveness of efimosfermin alfa in improving liver fibrosis and resolving steatohepatitis in adults with metabolic dysfunction-associated steatohepatitis (MASH) confirmed by biopsy showing stage F2 or F3 fibrosis. The study compares efimosfermin alfa to a placebo and focuses on individuals with confirmed liver damage and metabolic syndrome features. Participants will receive either efimosfermin alfa or placebo, administered as a drug treatment. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial with three groups. Treatment effects will be assessed over 52 weeks, with a primary focus on liver fibrosis and steatohepatitis changes. The study includes long-term monitoring of liver-related clinical outcomes up to 48 months after randomization. During the study, participants will undergo liver biopsies confirmed by central pathology review, and researchers will monitor liver function and fibrosis improvement. Outcome measures include the proportion of participants showing fibrosis improvement without worsening steatohepatitis, resolution of steatohepatitis with stable fibrosis, and time to liver-related clinical events. Safety and efficacy will be closely evaluated throughout the treatment and follow-up periods.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

This research aims to evaluate the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy in adults with previously untreated, unresectable, or metastatic colorectal cancer. The study is a blinded, randomized Phase 2/3 trial targeting participants with histologically confirmed recurrent or metastatic colorectal adenocarcinoma that cannot be cured with surgery. Participants must not have certain genetic markers such as mismatch repair deficiency, microsatellite instability-high status, or BRAF V600E mutation. Participants will receive either pumitamig or bevacizumab along with chemotherapy regimens including FOLFOX, FOLFIRI, or CAPOX at specified doses and schedules. The interventions involve administering these drugs on specified days, though exact dosing details are not provided. The study compares these two treatment combinations to assess their safety and efficacy in this patient population. Throughout the study, participants will be monitored for tumor response using RECIST v1.1 criteria, progression-free survival, and overall survival for up to five years. Researchers will evaluate confirmed complete or partial tumor responses, survival rates, and disease progression. The study includes regular assessments to track treatment effects and safety over a long-term follow-up period, ensuring comprehensive monitoring of participant outcomes.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are evaluating the safety and effects of two study medicines, PF-07275315 and PF-07264660, in adults with moderate to severe atopic dermatitis (AD). AD is a long-lasting itchy red rash caused by a skin reaction. The study seeks participants aged 18 or older who have had AD for at least six months, have not responded well to topical treatments, and are considered by their doctors to have moderate to severe AD. The study is divided into four stages. In Stage 1, participants received either PF-07275315, PF-07264660, or placebo; this stage is complete. In Stage 2, participants receive either PF-07275315 or placebo. In Stage 3, participants who previously received anti-inflammatory proteins will receive PF-07275315 or placebo. In Stage 4, participants will receive PF-07264660 or placebo. All treatments are given as multiple shots under the skin at the clinic during each stage. Placebo shots look like the study medicines but contain no active drug. Participants will be involved for up to 40 weeks (10 months) in Stages 1, 2, and 4, and up to 52 weeks (13 months) in Stage 3. Researchers will regularly assess their skin condition, measure improvements, and monitor for any side effects. The main outcome is the number of participants achieving at least 75% improvement in their eczema severity score at week 16. Participants will attend scheduled visits, lab tests, and follow study procedures throughout the study.

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 safety of the IC-8 Apthera intraocular lens (IOL) after treatment for posterior capsular opacification (PCO), a common complication following IC-8 Apthera IOL implantation. This post-approval study is prospective, multi-center, and non-randomized, focusing on subjects who have previously received the IC-8 Apthera IOL and later developed PCO requiring Nd:YAG laser capsulotomy treatment. The study aims to monitor safety outcomes following this laser treatment using a standardized technique after sufficient surgeon training. Participants will receive the Nd:YAG laser capsulotomy treatment to address PCO in the eye with the IC-8 Apthera IOL. The study involves a single group of subjects, all having undergone prior IC-8 Apthera IOL implantation, with the other eye implanted with a monofocal or monofocal toric IOL. The study includes about six visits over a 24-month period following the IC-8 Apthera IOL implantation, during which safety and treatment outcomes will be assessed. During the study, subjects will be monitored for several outcomes including rates of additional Nd:YAG laser treatments, treatment complications, intraocular lens related assessments, secondary surgical interventions, serious adverse events, ocular adverse events, and subjective visual disturbances using specific questionnaires. Safety and effectiveness assessments will be conducted across the 24 months post-implantation, ensuring comprehensive evaluation of the IC-8 Apthera IOL after PCO treatment.

Researchers are evaluating two types of electrical stimulation—alternating current and direct current—as additional treatments for lumbosacral radiculopathy, a condition affecting the nerves in the lower back and legs. This study aims to compare the effects of a novel direct current device called Neubie with the traditional Transcutaneous Electrical Nerve Stimulation (TENS) unit in physical therapy. The goal is to understand how these treatments impact pain levels, functional ability, nerve function, and patient satisfaction over time. Participants will undergo a 6-week treatment program at one of 16 physical therapy clinics. The study includes an initial evaluation with pain scales, disability questionnaires, nerve tests, and a Straight Leg Raise Test to assess nerve irritation. During treatment, participants receive 12 physical therapy sessions involving 30 minutes of exercises combined with either Neubie direct current stimulation or traditional TENS alternating current stimulation. If symptoms persist after 6 weeks, participants can continue treatment for up to 12 more sessions over an additional 6 weeks. Throughout the study, patients will be evaluated before treatment, at 6 weeks, and at 12 weeks using pain ratings, disability assessments, nerve function tests, and the Straight Leg Raise Test. Patient satisfaction with treatment will also be recorded. These measurements will help determine the treatments’ effects on radiculopathy symptoms and physical function, with close monitoring of neurological and functional changes over the study period.