Gastonia

Researchers are evaluating the efficacy and safety of HBS-301 in treating symptoms of idiopathic hypersomnia (IH), including excessive daytime sleepiness, sleep inertia, and fatigue. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 18 years and older diagnosed with IH. The study aims to compare HBS-301 to a placebo in relieving these symptoms and to assess its overall safety profile. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets during an 8-week double-blind treatment period. Before this, there is a screening and baseline period lasting up to 28 days. Following the double-blind phase, participants have the option to join a one-year open-label extension period where they may receive HBS-301. After completing treatment, a 30-day safety follow-up will monitor participants for any adverse effects. Throughout the study, participants will undergo various assessments including sleep studies and symptom evaluations to measure the effectiveness of HBS-301. Researchers will track changes in idiopathic hypersomnia symptoms from baseline through the end of the double-blind period. Safety will also be closely monitored during treatment and follow-up periods to ensure participant well-being over the course of the study, which may last over a year for those in the extension phase.

Researchers are evaluating the safety and effectiveness of fixed dose combinations of ensifentrine with two different doses of glycopyrrolate compared to placebo and each drug alone in adults with chronic obstructive pulmonary disease (COPD). This phase IIb study focuses on measuring lung function improvements using bronchodilator effects in people with COPD. Participants have a history of smoking and meet specific lung function criteria to be included. Participants will be randomly assigned to one of six groups: two combination treatments of ensifentrine (3 mg) with glycopyrrolate at either 21.25 or 42.5 mcg, each drug alone as monotherapy, or placebo. All treatments are given twice daily for 28 days using a standard jet nebulizer. The study includes 1 to 2 weeks of screening, 4 weeks of treatment, followed by 1 week of follow-up. During the study, participants will undergo lung function testing at baseline and on days 1, 14, 28, and 29 to measure changes in forced expiratory volume in one second (FEV1). They will also have chest X-rays or CT scans reviewed, complete questionnaires on breathlessness, and have regular assessments to monitor safety and treatment effects. Participants must be able to use the nebulizer properly and attend all study visits over approximately 7 weeks.

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.

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.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

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.

Researchers are investigating the potential benefits of GB-0895 as an additional treatment for adolescents and adults with severe asthma that remains uncontrolled despite using inhaled corticosteroids and other usual asthma treatments. This global, multicenter Phase 3 trial compares the effects of GB-0895 to a placebo in patients aged 12 to 80 years with severe uncontrolled asthma. The study also includes an optional open-label extension phase to further assess long-term effects and safety. Participants are randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every 6 months over a 52-week treatment period. Before treatment, there is a screening and run-in phase lasting about 6 weeks. After the 52 weeks of treatment, participants enter a follow-up period lasting up to 38 weeks or may choose to join the optional open-label extension lasting up to 90 weeks, during which they continue receiving GB-0895 at specified intervals. Throughout the study, participants attend visits every 1 to 2 months after the first month to monitor their health and asthma control. Researchers evaluate the annualized asthma exacerbation rate as the main outcome. Safety assessments include physical exams, vital signs, lab tests, and careful monitoring for adverse effects. The study aims to enroll about 786 participants globally to thoroughly assess the safety and effectiveness of GB-0895 as an add-on therapy for severe uncontrolled asthma.

Researchers are evaluating the safety and effects of a study medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. This condition makes breathing difficult and affects quality of life. The study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to determine if PF-07275315 is safe and effective for this group. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections administered in the clinic over 12 weeks. The study compares these two groups to assess treatment responses. The trial includes a total of 9 clinic visits and lasts about 7.5 months for each participant. During the study, participants will undergo various assessments including lung function tests to measure forced expiratory volume in 1 second (FEV1), safety monitoring through adverse event tracking, laboratory tests, vital sign checks, and electrocardiograms. These evaluations occur from baseline through 24 weeks to observe changes and treatment tolerability.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

This research collects data and biological samples from patients who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and clinical information to help future studies understand, predict, prevent, and treat serious immune-related side effects, rare infections, or rapid tumor growth after immunotherapy. Participants provide tissue and blood samples when they join the study and again one month later. Some patients may also provide stool samples if they have certain side effects like colitis. Researchers also review participants' medical records for up to one year to gather detailed health information related to their treatment and side effects. During the study, patients undergo sample collections and have their health records examined. The main outcome measured is the establishment of a national biorepository containing these samples and data, which will be used in future research over the course of one year. This study aims to support better understanding and management of immunotherapy side effects in cancer treatment.